Clinical trial NCT02313675
Conditions: Postoperative Pain Carpal Tunnel Release Distal Radius Fracture
Keywords: carpal tunnel syndrome opioid analgesics postoperative pain IV tylenol IV toradol
Sponsor: John Fowler
Start date: 2015-05-01; Completion date: 2017-05-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to determine the efficacy of intra-operative administration of IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients and distal radius fracture patients.

Detailed description:
The study population will include patients presenting for surgery with carpal tunnel syndrome as well as surgical treatment of distal radius fracture. Patients will be treated intra-operatively with either IV tylenol, IV toradol, both, or neither. All patients will receive the standard post-operative prescriptions for pain management. Daily pain surveys scoring pain from 0-10 will be distributed to the subjects to be filled out over the course of 10 days prior to first post-operative visit, usually 10-14 days later. Number of pain pills used before the first post-operative visit will also be measured.

We hypothesize that the effects of intra-operative administration of IV tylenol and/or IV toradol will have a significant effect on decreasing post-operative pain in the first 10 days following distal radius fracture surgeries, with a significant difference in pain described as at least a 2 points on a 0-10 pain scale.

We also hypothesize that intra-operative administration of IV tylenol and/or IV toradol will not have such significant effect on decreasing post-operative pain for carpal tunnel release surgery.

A secondary aim is to evaluate the post-operative opioid consumption of patients within these treatment groups. We hypothesize that opioid consumption will be decreased in the groups receiving IV tylenol and/or toradol for distal radius fracture surgery compared to the placebo group. We do not expect such a difference for the carpal tunnel release surgery group.

Arms: arm 1: One time intra-operative IV acetaminophen administration arm 2: One time intra-operative IV ketorolac thromethamine administration arm 3: One time intra-operative IV combination of acetaminophen/ketorolac administration arm 4: One time intra-operative 50ml IV normal saline administration
Interventions: intervention 1: Acetaminophen intervention 2: Ketorolac Tromethamine intervention 3: Saline
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Prot_000.pdf: 
Pain Outcomes of Intra-operative IV Tylenol and/or Toradol for Carpal Tunnel and Distal 
Radius Fracture Surgeries 
NCT 02313675 
Initial IRB approval: 5/11/15 
Most recent IRB renewal: 1/25/17 


This study was designed as a randomized, double-blind, placebo-controlled study. The study was 
approved by our local Institutional Review Board, PRO14110464. It was registered with 
Clinicaltrials.gov, NCT02313675. Patients were recruited from the clinical practice of the senior 
author and enrolled in the study if consented to undergo endoscopic carpal tunnel release. The 
following exclusion criteria were used: current pregnancy, allergy to acetaminophen or 
ketorolac; medical contraindication to acetaminophen and/or ketorolac; pre-operative/current use 
of opioids; history of IV drug abuse; workers’ compensation. 
The Investigational Drug Service (IDS) at our institution randomized subjects using a blocked 
computerized randomization protocol and dispensed the study medication. The four treatment 
arms include: placebo (Group 1), IV acetaminophen (Group 2), IV ketorolac (Group 3), or both 
IV acetaminophen and IV ketorolac (Group 4). The dose of ketorolac was 10 mg and the dose of 
acetaminophen was 1000 mg. Subjects and surgeon were blinded to the medication given as IDS 
will dispensed the medications in opaque syringes. The medications were given 5 minutes prior 
to skin incision. 
All patients undergoing carpal tunnel release were treated according to the same standard 
protocol for anesthesia and pain control. Patients were placed under sedation by the 
anesthesiologist using a standard weight-based dose of propofol and maintained on light sedation 
using a standard weight-based titration of propofol. After adequate sedation, the senior author 
injected a mixture of 5 mL of 1% lidocaine and 5 mL of 0.5% marcaine into the surgical field for 
intra-operative procedural anesthesia. All carpal tunnel releases were performed using a single 
incision endoscopic technique. 
All patients received the same standard post-operative prescriptions for pain management: 
Tylenol 1000 mg by mouth every 8 hours, naproxen 500 mg by mouth every 12 hours, and 
oxycodone 5 mg by mouth every 6 hours as needed for severe pain rated as more than 7 out of 10 
on an 11-point pain scale (0-10). Each oxycodone prescription was for 20 tablets and no refills 
were authorized. Pain surveys were distributed to the subjects on the day of surgery and the 
subjects were instructed to complete the surveys every 8 hours for 7 days after surgery. The 
subjects also noted the number of oxycodone tablets consumed per day. 

SAP_001.pdf: 
Pain Outcomes of Intra-operative IV Tylenol and/or Toradol for Carpal Tunnel and Distal 
Radius Fracture Surgeries 
 
NCT 02313675 
 
Initial IRB approval: 5/11/15 
Most recent IRB renewal: 1/25/17 


An a priori power analysis determined that eleven subjects per treatment group were required 
(total of 44 patients) to detect a difference in the 11-point pain score of 1.0 between groups. 
Patients recorded pain levels at 8 hour intervals and daily opioid use for seven days after surgery. 
Data analysis included calculation of descriptive statistics including frequency counts and 
percentages for categorical variables and measures of central tendency (means, medians) and 
dispersion (standard deviations, ranges) for continuous variables. ANOVA and Kruskal-Wallis 
tests were used to compare mean pain and opioid consumption between groups.