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Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis

Primary Purpose

Carpometacarpal Osteoarthritis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Placebo: Multivitamin
Sponsored by
Indiana Hand to Shoulder Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Carpometacarpal Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Adults (18 years of age or older)
  • Patients presenting with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis
  • Eaton Classification stage II, III, or IV OA of the first CMC joint based on xrays
  • Patients who plan to undergo a ligament reconstruction and tendon interposition (LRTI) or thumb suspensionplasty procedure within 6 months of enrolling to study
  • Bilateral thumbs included

Exclusion Criteria:

  • <18 years age
  • Prior surgical history of ipsilateral 1st CMC arthroplasty or procedures involving thumb CMC joints
  • Prior ipsilateral tendon rupture or ipsilateral peripheral nerve palsy
  • History of opioid dependency or current chronic opioid use
  • Contraindication to acetaminophen use
  • Contraindication to NSAID use
  • Contraindication or known allergy to peripheral nerve blockade, including coagulopathy
  • Contraindication to supraclavicular block due to anatomic variability or inability to tolerate phrenic nerve blockade.
  • Contraindication to multivitamin use
  • Liver dysfunction

Sites / Locations

  • Indiana Hand to Shoulder CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Test Group

Arm Description

Preoperative multivitamin and postoperative standardized pain management regimen

: Preoperative acetaminophen and postoperative standardized pain management regimen

Outcomes

Primary Outcome Measures

Visual Analogue Scale (VAS)
Patients report pain on a scale of 0 (no pain) to 100 (worst possible pain)
Number of Narcotic Pills Used
Number of Narcotic Pills Used

Secondary Outcome Measures

Full Information

First Posted
September 22, 2022
Last Updated
September 26, 2023
Sponsor
Indiana Hand to Shoulder Center
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1. Study Identification

Unique Protocol Identification Number
NCT05556356
Brief Title
Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis
Official Title
Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana Hand to Shoulder Center

4. Oversight

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

5. Study Description

Brief Summary
Basilar thumb arthritis is a common problem that affects 7% of men and 15% of women. It is regarded as one of the more painful procedures commonly performed by hand surgeons. Opioid overuse and diversion are significant problems in the country that contribute to opioid addiction as well as deaths from opioid overdose. Prior studies have examined the effect of different nerve block compositions on perioperative and postoperative analgesia, but none have looked at perioperative loading analgesia. We will attempt to address this problem by exploring alternative analgesia regimens to decrease opioid prescribing after 1st carpometacarpal (CMC) joint arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpometacarpal Osteoarthritis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Preoperative multivitamin and postoperative standardized pain management regimen
Arm Title
Test Group
Arm Type
Experimental
Arm Description
: Preoperative acetaminophen and postoperative standardized pain management regimen
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
pre-operative acetaminophen (1000mg)
Intervention Type
Other
Intervention Name(s)
Placebo: Multivitamin
Intervention Description
pre-operative Multivitamin
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
Patients report pain on a scale of 0 (no pain) to 100 (worst possible pain)
Time Frame
2 weeks
Title
Number of Narcotic Pills Used
Description
Number of Narcotic Pills Used
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (18 years of age or older) Patients presenting with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis Eaton Classification stage II, III, or IV OA of the first CMC joint based on xrays Patients who plan to undergo a ligament reconstruction and tendon interposition (LRTI) or thumb suspensionplasty procedure within 6 months of enrolling to study Bilateral thumbs included Exclusion Criteria: <18 years age Prior surgical history of ipsilateral 1st CMC arthroplasty or procedures involving thumb CMC joints Prior ipsilateral tendon rupture or ipsilateral peripheral nerve palsy History of opioid dependency or current chronic opioid use Contraindication to acetaminophen use Contraindication to NSAID use Contraindication or known allergy to peripheral nerve blockade, including coagulopathy Contraindication to supraclavicular block due to anatomic variability or inability to tolerate phrenic nerve blockade. Contraindication to multivitamin use Liver dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lexie Reissaus, CCRP
Phone
317-471-4312
Email
lreissaus@ihtsc.com
Facility Information:
Facility Name
Indiana Hand to Shoulder Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lexie Reissaus, CCRP
Phone
317-471-4312
Email
lreissaus@ihtsc.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis

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