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Prospective Pain Study Comparing Different Treatments After Hand Surgery

Primary Purpose

Post-operative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5mg of Oxycodone every 6 hours as needed for pain
600mg of Ibuprofen every 6 hours as needed for pain
500mg of Acetaminophen every 6 hours as needed for pain
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Patients indicated to undergo primary, unilateral carpal tunnel release or trigger finger release surgery under local anesthesia alone.
  2. Age eligibility is > 18 years of age.
  3. Local anesthesia with 1% lidocaine with 1:100,000 epinephrine and Bicarbonate.

Exclusion Criteria

  1. Bilateral procedures.
  2. Additional soft tissue or boney procedures performed simultaneously.
  3. The use of sedation and/or general anesthesia.
  4. Pediatric patients (age < 18 years).
  5. Pregnant female patients.
  6. Non-English speaking patients.
  7. Known allergies or medical contraindications to Oxycodone, Ibuprofen, Acetaminophen.
  8. History of chronic pain and/or narcotic use preoperatively.

Sites / Locations

  • Rothman Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Opioid Group

NSAID group

Acetaminophen

Arm Description

Outcomes

Primary Outcome Measures

Numeric rating Scale for Pain
11-point numeric rating scale (NRS) for pain

Secondary Outcome Measures

Full Information

First Posted
July 12, 2018
Last Updated
July 12, 2018
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT03597308
Brief Title
Prospective Pain Study Comparing Different Treatments After Hand Surgery
Official Title
PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING OXYCODONE, IBUPROFEN AND ACETAMINOPHEN AFTER WIDE AWAKE HAND SURGERY
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 17, 2017 (Actual)
Primary Completion Date
July 14, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the efficacy of three different types of pain medication (Oxycodone - an opioid, Ibuprofen - a non-steroidal anti-inflammatory, and Acetaminophen - a non-opioid analgesic) in the management of postoperative pain following single soft tissue procedures of the hand and wrist performed exclusively under local anesthesia without sedation. The results of this study will help define optimal prescribing guidelines following the two most common hand surgeries while also potentially validating the use of opioid alternatives post-operatively in order to help mitigate excessive or unnecessary dispensal of opioid analgesics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Opioid Group
Arm Type
Active Comparator
Arm Title
NSAID group
Arm Type
Active Comparator
Arm Title
Acetaminophen
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
5mg of Oxycodone every 6 hours as needed for pain
Intervention Description
5mg of Oxycodone every 6 hours as needed for pain
Intervention Type
Drug
Intervention Name(s)
600mg of Ibuprofen every 6 hours as needed for pain
Intervention Description
600mg of Ibuprofen every 6 hours as needed for pain
Intervention Type
Drug
Intervention Name(s)
500mg of Acetaminophen every 6 hours as needed for pain
Intervention Description
500mg of Acetaminophen every 6 hours as needed for pain
Primary Outcome Measure Information:
Title
Numeric rating Scale for Pain
Description
11-point numeric rating scale (NRS) for pain
Time Frame
2 weeks post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients indicated to undergo primary, unilateral carpal tunnel release or trigger finger release surgery under local anesthesia alone. Age eligibility is > 18 years of age. Local anesthesia with 1% lidocaine with 1:100,000 epinephrine and Bicarbonate. Exclusion Criteria Bilateral procedures. Additional soft tissue or boney procedures performed simultaneously. The use of sedation and/or general anesthesia. Pediatric patients (age < 18 years). Pregnant female patients. Non-English speaking patients. Known allergies or medical contraindications to Oxycodone, Ibuprofen, Acetaminophen. History of chronic pain and/or narcotic use preoperatively.
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prospective Pain Study Comparing Different Treatments After Hand Surgery

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