If you don't remember your password, you can reset it by entering your email address and clicking the Reset Password button. You will then receive an email that contains a secure link for resetting your password
If the address matches a valid account an email will be sent to __email__ with instructions for resetting your password
Adequate postoperative pain control in hand surgery is a multifactorial issue affecting patient satisfaction, outcomes, and safety. However, prescription opioid abuse is becoming an increasingly prevalent problem in the Unites States. The purpose of this study was to determine if there was a difference in pain levels or pill consumption when using nonopioids, ibuprofen (IBU) and acetaminophen (ACE), versus an opioid, oxycodone (OXY), after carpal tunnel release (CTR) performed exclusively under local anesthesia without sedation.
Patients scheduled for primary unilateral CTR under local anesthesia alone were randomized to receive 10 deidentified opaque capsules of either OXY 5 mg, IBU 600 mg, or ACE 500 mg after surgery. Both the patient and the surgeon were blinded to the distributed medication. Patients reported the worst pain experienced daily (0–10 scale), the number of pills consumed daily, and any adverse effects from postoperative days 0–5.
Analgesic pill-type distribution between the 105 patients who completed the study was 37 OXY, 34 IBU, and 34 ACE. For the endoscopic CTR group, mean total pills consumed from the day of surgery through postoperative day 5 for OXY, IBU, and ACE were 2.9, 4.2, and 2.7, respectively. The average worst daily pain scores for all days for the OXY, IBU, and ACE groups were 2.8, 2.5, and 2.8, respectively. For the open CTR group, mean total pills consumed from the day of surgery through postoperative day 5 for OXY, IBU, and ACE were 3.7, 5.1, and 4.2, respectively. The average worst daily pain scores for all days for the OXY, IBU, and ACE groups were 3.4, 2.5, and 2.3, respectively. Four of 5 adverse events were reported by OXY group patients, but all were minor with no reoperations or readmissions.
We recommend using nonopioids such as ACE and IBU in the postoperative management after CTR surgery, and regardless of the medication prescribed, we advise prescribing no more than 5–10 pills after surgery.
Although adequate pain control affords improved patient satisfaction and potentially speeds up rehabilitation, there is growing evidence that patients are being overprescribed opioids with potentially negative consequences for both the individual patients and the community at large.
In fact, the Centers for Disease Control and Prevention estimate that nearly 15,000 people die each year in the United States from prescription painkillers including hydrocodone and oxycodone, resulting in what is being referred to as an opioid crisis.
Related to hand and upper extremity surgery, we have previously found that patients are being inappropriately prescribed 3 times more than the number of opioids needed after upper extremity surgeries in general, and 5 times more than the number of opioids needed after carpal tunnel release (CTR) surgery specifically.
recently reported that approximately 6% of preoperatively opioid-naïve patients continue to consume opioids 6 months after surgery, irrespective of whether the surgery was deemed major or minor, including hand surgery.
demonstrated that 13% of opioid-naïve patients continue to fill opioid prescriptions 90 days after hand surgery procedures.
Given the improved awareness of the risks associated with inappropriate opioid overprescribing, there is a general move to decrease the number of postoperative opioids prescribed and to increase the use of nonopioids whenever possible.
To evaluate the efficacy of using nonopioids in hand surgery, we undertook a prospective, double-blinded, randomized controlled trial evaluating opioid versus nonopioid pain medications after CTR surgery. Our study hypothesis was that there would be no difference in pain levels or pill consumption after surgery between opioids and nonopioids.
After institutional review board approval was obtained, a prospective, randomized, controlled, double-blinded study was undertaken with 2 hand surgery fellowship-trained, board-certified orthopedic surgeons, who performed CTR surgery under local anesthesia without sedation. We adhered to the Consolidated Standards of Reporting Trials guidelines. During their preoperative office visit, patients were invited to participate if they were older than 18 years of age and were indicated to undergo an isolated, primary, unilateral CTR under local anesthesia. Exclusion criteria included bilateral procedures, additional soft tissue or bony procedures performed simultaneously, the use of sedation and/or general anesthesia, pregnant female patients, non–English speaking patients, known allergies or medical contraindications to oxycodone (OXY), ibuprofen (IBU), acetaminophen (ACE), lidocaine and/or epinephrine, and a history of chronic pain and/or current opioid use. After obtaining consent, the patient’s demographic information and surgical details were entered into a secure, password-protected research database that was organized and maintained by the nonblinded research coordinator.
Postoperative study medications were prepared by a consulting pharmacy. Patients were randomized to receive one of the following 3 postoperative pain medications: OXY 5 mg, IBU 600 mg, or ACE 500 mg. All medications were formulated into opaque pill capsules and containers and labeled with serial numbers. Each container included 10 of the aforementioned pills, with instructions to take 1 pill every 6 hours as needed for pain. Both the patient and the surgeon were blinded to the medication type.
The allocations were maintained, randomized, and distributed by the nonblinded research coordinator, who provided them to the surgical facilities and the physician for dispersal to the patient on the day of surgery (DOS). Furthermore, the research coordinator maintained the drug accountability log for all medications that were secured and distributed to the patients. In addition to receiving the medications on the DOS, the patients were given a pain diary log to maintain and to return along with the pill container at the first postoperative visit.
All surgical procedures were performed by the 2 surgeons in an identical manner. The surgical site was infiltrated with a total of 15–20 mL of 1% lidocaine with epinephrine and 1–2 mL of bicarbonate. No preoperative antibiotics were given. After standard surgical preparation, either a mini-open or endoscopic CTR was performed. For the mini-open CTR, an incision was placed in the base of the palm in line with the third webspace. After dissection past the superficial palmar fascia and once satisfied the transverse carpal ligament (TCL) was clear of any traversing nerve branches, the ligament was released sharply until complete decompression of the median nerve was confirmed under direct visualization. The wound was washed and closed. A soft dressing was applied, which patients were advised to remove 2 days after surgery.
For the endoscopic CTR, a transverse incision was made proximal to the wrist flexion crease, lining up with the ring finger, and ulnar to the palmaris longus. Subcutaneous tissues were dissected sharply down to the antebrachial fascia, which was incised. At this point, the synovial elevator was inserted underneath the transverse carpal ligament to remove any adhesions from the undersurface of the TCL. Once the tip of the elevator could be palpated at the distal edge of the carpal tunnel, it was replaced with a hamate finder, which created a path for the blade assembly. Next, the endoscope (Microaire, Charlottesville, VA) was introduced into the carpal tunnel while aiming at the ring finger, hugging the hook of the hamate, and pressing against the deep side of the ligament. After defining the distal aspect of the TCL and having a clear view of the transverse fibers of the TCL, the blade was elevated, and the distal half of the TCL was released. The blade was then dropped, and complete release of the distal half of the TCL was confirmed. Then, the proximal half of the TCL was released. Finally, the blade assembly was reinserted to verify complete TCL release. The wound was washed and closed. A soft dressing was applied that could be removed 2 days after surgery.
After surgery, all patients were asked not to take any other pain medications in addition to, or in place of, the study medications. If a different, stronger, or lighter medication was desired, the patient was instructed to contact the surgeon. At that point, the patient and surgeon would be unblinded by the research coordinator so that an appropriate alternative medication could be prescribed. This event was recorded. In addition, if all 10 prescribed pills had been consumed and a refill of the same medication was requested, then the surgeon was unblinded to allow for an appropriate refill. Lastly, if the patient experienced any adverse event from the prescribed study medication, then the surgeon was unblinded and appropriate management was initiated.
Within 2 weeks of the surgery, patients were seen directly by their treating surgeon for their first postoperative visit. During this visit, the pill container with any remaining pills was collected, the pain diary was collected, and a questionnaire assessing satisfaction with the pain medications and any adverse events was administered. The patient’s pain diary log recorded the following information: worst pain experienced during each day, the number of pills consumed each day, the duration of pill consumption, and overall satisfaction rating of their pain control. The pain diary employed a daily 11-point numeric rating scale (NRS) for pain that has been validated by prior studies.
Patient satisfaction was assessed using a series of 3 questionnaire items: (1) Were the 10 painkillers provided after surgery an adequate amount? (2) Were the painkillers strong enough to manage the pain after surgery? (3) Were the painkillers too strong for managing the pain after surgery. In the provided questionnaire, the patient’s answer options consisted of the following: strongly agree, agree, neutral, disagree, and strongly disagree.
Descriptive statistics were performed on all demographic data. In addition, single-factor analysis of variance was used to determine whether differences in discrete variables (number of pills consumed daily and daily pain scores) between randomized medication groups reached statistical significance (P < .05). Group subanalyses and post hoc tests were performed using independent t-tests. To detect a 1 pill difference in consumption and a 1.0-unit difference as measured on a visual analog scale for pain, we estimated that 16 patients per medication cohort would be necessary to detect a significant difference. To account for attrition, we attempted to consent over 100 patients.
A total of 110 patients undergoing isolated, primary unilateral CTR under local anesthesia alone were enrolled in the study. Forty-nine patients underwent mini-open CTR and 61 underwent an endoscopic CTR. The cohort comprised 52% females (57) and 48% (53) males. The average age of the participants was 61 years (range: 19–88 y; standard deviation: 12.5). Blinded analgesic medication distribution was as follows: 39 patients received OXY, 34 patients received IBU, and 37 patients received ACE. Based on our protocol, 5 patients were excluded from the study. In these cases (3 patients receiving ACE; 2 patients receiving OXY), the patients contacted the office for a stronger medication, and the patients and their surgeon were unblinded. Subsequently, these patients were prescribed an alternative pain medication based on their preference.
Excluding the 5 patients reviewed above, the remaining 105 patients completed the study (53 female patients and 52 male patients). The mean age was 62 years (range: 19–88 y; standard deviation: 12.0). Mini-open CTR was performed in 46 cases and the endoscopic technique was used in 59 cases. Surgery was performed on the right side in 61 patients and on the left side in 44 patients. Patient demographics and subgroups are shown in Table 1.
For the endoscopic CTR group, the average total pills consumed from the DOS through postoperative day 5 for the OXY, IBU, and ACE groups were 2.9, 4.2, and 2.7, respectively (P > .05). Throughout the study period, the average worst daily pain scores (0–10 scale) for the OXY, IBU, and ACE groups were 2.8, 2.5, and 2.8, respectively (P > .05).
For the mini-open CTR group, the average total pills consumed from the DOS through postoperative day 5 for the OXY, IBU, and ACE groups were 3.7, 5.1, and 4.2, respectively (P > .05). Throughout the study period, the average worst daily pain scores (0–10 scale) for the OXY, IBU, and ACE groups were 3.4, 2.5, and 2.3, respectively (P < .05). Post hoc 1-tailed independent t-tests confirmed significantly greater average daily pain scores in the OXY group when compared with the IBU and ACE groups (P < .05). The differences in average daily pain scores between the IBU and ACE groups were not significant.
For each of the 3 pain medicine groups, mean average pill consumption did not differ between patients undergoing mini-open CTR and those undergoing endoscopic CTR (P > .05) (Fig. 1). Similarly, there was no difference in average worst daily pain scores between these groups (P > .05) (Fig. 2).
Five patients (2 patients receiving OXY, 2 patients receiving IBU, and 1 patient receiving ACE) disclosed taking a different pain medication at some point during the study period but were maintained in the study based on the intention-to-treat principle. Specifically, 1 patient discontinued his or her blinded pain medication (ACE) secondary to ineffectiveness and independently started taking IBU. One patient (IBU) opted not to take the study medication after leaving the surgery center and instead took a combination of over-the-counter medications of his or her choice. The other 3 patients (2 OXY, 1 IBU) took their blinded pain medication but also supplemented with a different medication at least once during the study period. Excluding these 5 patients from the data analysis did not alter any of the findings. Furthermore, 3 patients requested a refill beyond their 10 prescribed pills (2 patients who received IBU, 1 patient who received ACE).
Of the 105 patients completing the study, 5% experienced an adverse reaction to their assigned medication. All 5 adverse reactions were minor in nature and were discovered at the first postoperative visit via the questionnaire. Four patients in the OXY group (11%) had an adverse reaction. Three of these patients experienced nausea and 1 experienced mild pruritus. One patient in the ACE group (3%) reported an episode of diarrhea after taking the medication. No patients in the IBU group reported an adverse reaction.
On average, patients overwhelmingly agreed that 10 pills were an adequate amount (strongly agree or agree: OXY = 88%; IBU = 91%; ACE = 91%) and that the provided medication was strong enough (strongly agree or agree: OXY = 76%; IBU = 72%; ACE = 81%). Furthermore, patients did not feel that the pain medication was too strong (strongly disagree or disagree: OXY = 85%; IBU = 88%; ACE = 87%). Detailed results are shown in Table 2.
Perioperative pain management in surgery is becoming increasingly challenging. Although there is growing pressure to make the surgical experience more pain free, the use of opioids to manage postoperative pain is complicated by the ongoing opioid crisis. For instance, CTR is the most common procedure performed by hand surgeons, yet opioids are routinely overprescribed in the attempt to better manage patients’ postoperative pain.
The findings of this study challenge the efficacy of routinely prescribing opioids after CTR surgery.
In terms of overall pain experience after mini-open CTR, the OXY group had more pain with an average pain score of 3.4 (on a 0–10 scale), compared with 2.5 for IBU and 2.3 for ACE. However, the minimal clinical important difference for the pain NRS, which is dependent on the specific procedure, is unknown in patients undergoing CTR. In fact, for upper extremity surgeries, the only known minimal clinical important difference for pain NRS is limited to shoulder arthroplasty, for which it is 1.4.
Determining the minimal clinically important difference for the American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and visual analog scale (VAS) measuring pain after shoulder arthroplasty.
found that the minimal clinical important difference for pain NRS was 1.0 and that patient acceptable pain control was considered 3.3 or less. Given the borderline differences in NRS at levels that are thought to be acceptable, we would not consider the difference in our study to be clinically relevant.
In terms of overall pill consumption after either endoscopic or mini-open CTR, the average pill consumption of all 3 groups was similar. Furthermore, greatest pill consumption was on day 0 and day 1. Together, these findings suggest that patients should be advised to expect that their greatest pain will occur the day of and first day after surgery but that their pain may be equally effectively managed with nonopioids such as IBU or ACE. Overall, the consumption of 3–5 pills on average is consistent with patterns identified in other series.
Between the mini-open and endoscopic CTR groups, the pain experience and pill consumption were similar. Previous studies comparing open versus endoscopic techniques conflict regarding which procedure is more painful in the early postoperative course.
There are various reasons for why surgeons choose to prescribe a certain amount of opioids after surgery, and they may include wishing to not undertreat their patients’ pain, avoiding patient complaints, and preventing patient phone calls for refills. Interestingly, only 10 pills were prescribed to each group in our study, yet there were only 3 refill requests out of 105 participants (3%). Moreover, only 5 patients called to request a stronger pain medication, and 2 of them were already receiving OXY, which was the strongest medication used in this study. One of these patients was started on acetaminophen, whereas the other was given IBU. The other 3 patients who requested a stronger pain medication were receiving ACE. Of these 3, 1 was converted to Tylenol #3, 1 was started on IBU, and 1 was given naproxen. There were no requests for a different or stronger medication in the IBU group.
In terms of adverse events, there were no major events or reoperations, and only 5 patients complained of minor occurrences. Four of these 5 occurred in the OXY group and consisted of relatively typical opioid-related complications, such as nausea and pruritis. There was 1 patient in the ACE group who claimed that the medication caused diarrhea. There were no complaints of gastroesophageal reflux disease, excessive bleeding, or any other adverse events in the IBU group.
Overall, the findings demonstrated that patients were content with the amount and potency of the pain medication prescribed, regardless of the group they were in. Given that the study period only included the first 2 weeks after surgery, the true clinical outcomes cannot be determined by this study. However, surgical outcomes after open and endoscopic CTR are well established and were not the focus of this study.
Strengths of this study include its prospective nature, randomization, double-blinding of both the surgeon and patient, and the use of 3 commonly used, inexpensive, and readily available analgesics. Moreover, using CTR as the study procedure, including its 2 most common forms (open and endoscopic), is advantageous given that it is a commonly performed procedure. Lastly, limiting cases to those performed under local anesthesia alone removes any effect that the surgical anesthesia could potentially have contributed to the postoperative pain experience and/or adverse events.
There are several limitations of this study. First, the 5 patients who were excluded for requesting a stronger medication should ideally have been accounted for given that they were failures of treatment. Because this occurred to patients in various groups (2 OXY and 3 ACE) and only 1 of these patients was subsequently prescribed an opioid, we think it is unlikely to have changed the conclusion of the study. However, as no IBU patients requested stronger medications, it is possible that there is some clinical advantage to its preferential use. Secondly, we were unable to compare the patients who elected to enroll in this study with the ones who did not, and therefore, the results may be susceptible to bias from a volunteer effect. Thirdly, due to uneven distribution, 1 of our 6 treatment groups (ACE after open CTR) did not achieve the appropriate sample size based on our sample size estimate. Therefore, it is possible that we are underpowered to detect subtle differences. However, on the basis of the small differences seen between the groups in both pain experience and pill consumption, we believe that it is unlikely for any such difference to be clinically relevant. Finally, we evaluated only CTR surgery, and thereby we may have potentially limited the applicability of our findings to other surgeries.
In conclusion, on the basis of our study findings, we would recommend using nonopioids such as ACE and IBU for pain management after CTR surgery. Moreover, regardless of the medication prescribed, we would advise prescribing no more than 5–10 pills after CTR surgery.
This study was supported by a grant from the American Foundation for Surgery of the Hand - Clinical Grant #1430.
Determining the minimal clinically important difference for the American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and visual analog scale (VAS) measuring pain after shoulder arthroplasty.