Skip to main content
OpenTrials
Completed

NCT Number: NCT03873480

Trigger Thumb Randomized Controlled Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Trigger Thumb Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Entrapment Trigger Finger Disorder

Age range

0 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Difference in administered anesthesia

    Time frame: 3 years

    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 outcomes

  1. Difference in observed pain score

    Time frame: 3 years

    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

  2. Difference in operative time

    Time frame: 3 years

    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.

  3. Difference in length of stay

    Time frame: 3 years

    The secondary outcome will be the difference in total length of study following a trigger thumb surgery between the control group and intervention group.

  4. Difference in complication rates

    Time frame: 3 years

    The secondary outcome will be the difference in complication rates following a trigger thumb surgery between the control group and intervention group.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

Administration of Local Anesthetic in Trigger Thumb Surgery: A Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2019
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.