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NCT05556356 | RECRUITING | Carpometacarpal Osteoarthritis


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

Indiana Hand to Shoulder Center

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.

Condition or disease

Carpometacarpal Osteoarthritis

Intervention/treatment

Acetaminophen

Placebo: Multivitamin

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : SINGLE
Primary Purpose : OTHER
Official Title : Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis
Actual Study Start Date : 2022-09-13
Estimated Primary Completion Date : 2024-05
Estimated Study Completion Date : 2024-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT05556356


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Locations


RECRUITING

United States, Indiana

Indiana Hand to Shoulder Center

Indianapolis, Indiana, United States, 46260

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