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Trigger Thumb Randomized Controlled Trial

Primary Purpose

Trigger Thumb

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Administration of Marcaine without Epinephrine prior to the start of surgery
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Thumb

Eligibility Criteria

0 Years - 4 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. American Society of Anaesthesiologists (ASA) Classification of 1 or 2.
  3. Parental/guardian permission (informed consent).

Exclusion Criteria:

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

Sites / Locations

  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention Arm

Non-Intervention Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Difference in observed pain score
The secondary outcome will be the difference in observed pain scores during the post-operative period following a trigger thumb surgery between the control group and intervention group. The FLACC (face, legs, activity, consolability) Behavioural pain scale will be used. There are 5 components, e.g. face, legs, activity, cry, and consolability, that are given a grade of 0, 1, or 2. The sum of the each component grade will give the pain scale score. 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Difference in operative time
The secondary outcome will be the difference in operative time during the course of a trigger thumb surgery between the control group and intervention group.
Difference in length of stay
The secondary outcome will be the difference in total length of study following a trigger thumb surgery between the control group and intervention group.
Difference in complication rates
The secondary outcome will be the difference in complication rates following a trigger thumb surgery between the control group and intervention group.

Full Information

First Posted
March 11, 2019
Last Updated
September 15, 2022
Sponsor
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT03873480
Brief Title
Trigger Thumb Randomized Controlled Trial
Official Title
Administration of Local Anesthetic in Trigger Thumb Surgery: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
November 10, 2020 (Actual)
Study Completion Date
November 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Thumb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-Intervention Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Administration of Marcaine without Epinephrine prior to the start of surgery
Intervention Description
The intervention is the timing of administration of marcaine without epinephrine during a trigger thumb surgery.
Primary Outcome Measure Information:
Title
Difference in administered anesthesia
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Difference in observed pain score
Description
The secondary outcome will be the difference in observed pain scores during the post-operative period following a trigger thumb surgery between the control group and intervention group. The FLACC (face, legs, activity, consolability) Behavioural pain scale will be used. There are 5 components, e.g. face, legs, activity, cry, and consolability, that are given a grade of 0, 1, or 2. The sum of the each component grade will give the pain scale score. 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time Frame
3 years
Title
Difference in operative time
Description
The secondary outcome will be the difference in operative time during the course of a trigger thumb surgery between the control group and intervention group.
Time Frame
3 years
Title
Difference in length of stay
Description
The secondary outcome will be the difference in total length of study following a trigger thumb surgery between the control group and intervention group.
Time Frame
3 years
Title
Difference in complication rates
Description
The secondary outcome will be the difference in complication rates following a trigger thumb surgery between the control group and intervention group.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Apurva S Shah, MD, MBA
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Deidentified individual participant data will not be made available.

Learn more about this trial

Trigger Thumb Randomized Controlled Trial

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