Trigger Thumb Randomized Controlled Trial

NCT03873480 | Completed

• 1 other identifier: 18-015288
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

We are conducting this study to determine if administration of local anesthetic to the thumb prior to surgery can reduce the amount of anesthetic gas given during the course of surgery.

Conditions

Trigger Thumb

Outcome Measures

Primary Outcomes (1)

• Difference in administered anesthesia

  The primary outcome will be the difference in administered gaseous sevoflurane during the course of trigger thumb surgery between the control group and intervention group.

  3 years

Secondary Outcomes (4)

• Difference in observed pain score

  3 years

• Difference in operative time

  3 years

• Difference in length of stay

  3 years

• Difference in complication rates

  3 years

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

Participants randomized into the intervention group will receive an injection of 2.5 cc of 0.25% marcaine without epinephrine prior to the incision. The local anesthetic will be administered by the treating surgeon. All other aspects of the procedure will be kept in accordance with the standard of care for trigger thumb surgeries.

Procedure: Administration of Marcaine without Epinephrine prior to the start of surgery

Non-Intervention Arm

NO INTERVENTION

Those that are not randomized into the intervention group will receive the standard of care for a trigger thumb release, which is administration of 2.5 cc of 0.25% marcaine without epinephrine following completion of surgery. The local anesthetic will be administered by the treating surgeon.

Interventions

Administration of Marcaine without Epinephrine prior to the start of surgery PROCEDURE

The intervention is the timing of administration of marcaine without epinephrine during a trigger thumb surgery.

Intervention Arm

Eligibility Criteria

• Age: 0 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males or females, age 0-4 years, presenting to the Children's Hospital of Philadelphia (CHOP) Department of Orthopaedics with unilateral trigger thumb that requires surgical treatment.
• American Society of Anaesthesiologists (ASA) Classification of 1 or 2.
• Parental/guardian permission (informed consent).

You may not qualify if:

• Males or females over the age of 4.
• ASA Classification higher than 2.
• Patients presenting with systemic diseases or significant comorbidities.
• Patients that received treatment for trigger thumb at an outside institution.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Apurva S Shah, MD, MBA

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: October 2, 2018
• Primary Completion: November 10, 2020
• Study Completion: November 10, 2020
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)