Trigger ThumbNCT03873480
Trigger Thumb Randomized Controlled Trial
A study testing Administration of Marcaine without Epinephrine prior to the start of surgery in people with Trigger Thumb, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 4 years
- Conditions the study is for
- Trigger Thumb
- What is being tested?
- Administration of Marcaine without Epinephrine prior to the start of surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2018to 10 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Administration of Local Anesthetic in Trigger Thumb Surgery: A Randomized Clinical 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.
- Conditions
- Trigger Thumb
- Being tested
- Administration of Marcaine without Epinephrine prior to the start of surgery
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of Marcaine without Epinephrine prior to the start of surgeryProcedure or surgery
The intervention is the timing of administration of marcaine without epinephrine during a trigger thumb surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (4)
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
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start2 Oct 2018
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger ThumbStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Apurva S Shah, MD, MBA, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873480
- Sponsor's protocol ID
- 18-015288
- Status last verified
- Sep 2022
- First submitted
- 11 Mar 2019
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified individual participant data will not be made available.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Local Anesthetic in Trigger Thumb Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03873480
- Acronym / sponsor ID
- 18-015288
- Conditions
- Trigger Thumb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Procedure: Administration of Marcaine without Epinephrine prior to the start of surgeryParticipants 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. |
| 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. |
Who may qualify
- Ages
- 0 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of Marcaine without Epinephrine prior to the start of surgeryThe intervention is the timing of administration of marcaine without epinephrine during a trigger thumb surgery. | Procedure or surgery | Intervention Arm |
Primary outcome
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.
4 secondary outcomes
Difference in observed pain score
Time frame: 3 years
Difference in operative time
Time frame: 3 years
Difference in length of stay
Time frame: 3 years
Difference in complication rates
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: No. Deidentified individual participant data will not be made available.
Related trials for Trigger Thumb
Active, not recruiting
The TriggerHappy Trial
Trigger Finger, Trigger Thumb
Not yet recruiting
Pull-out Tenolysis Versus Simple A1 Pulley Release in Trigger Digits
Trigger Digit
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Apurva S Shah, MD, MBA principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of Marcaine without Epinephrine prior to the start of surgery in people with Trigger Thumb, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in administered anesthesia (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.