Timing of Tourniquet Release

NCT06576869 | Completed

• 1 other identifier: 22.028.02
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective randomized clinical trial comparing clinical outcome measures in patients who undergo elective upper extremity surgery when tourniquet is dropped prior to closure as opposed to when tourniquet is dropped after closure. The study will compare objective data obtained intraoperatively as well as standard clinical outcome measures such as pain scores at routine follow up.

Conditions

Injury

Keywords

Tourniquet study

Outcome Measures

Primary Outcomes (4)

• Visual analog pain scale

  Visual number scale to rate pain from 0-10 where 0 equals no pain and 10 equals worst possible pain

  2 weeks, 10 weeks and 6 months.

• Quick DASH form

  Assessment of symptoms and ability to perform certain activities.

  2 weeks, 10 weeks, 6 months.

• Hematoma assessment

  Performed by MD, assessment of the presence of a hematoma and if present, it is measured.

  2 weeks, 10 weeks, 6 months.

• Satisfaction with surgery

  Patient to rate their satisfaction with their surgery and to indicate whether or not they would recommend the surgery to family/friends with the same condition.

  2 weeks, 10 weeks, 6 months.

Study Arms (2)

A: Closure without releasing the tourniquet.

ACTIVE COMPARATOR

Tourniquet is dropped after closure.

Procedure: Upper extremity orthopedic surgeries.

B: Releasing the tourniquet and then closing the incision

ACTIVE COMPARATOR

Tourniquet is dropped prior to closure.

Procedure: Upper extremity orthopedic surgeries.

Interventions

Upper extremity orthopedic surgeries. PROCEDURE

Upper extremity orthopedic surgeries that require the use of a tourniquet.

A: Closure without releasing the tourniquet.; B: Releasing the tourniquet and then closing the incision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consented study subjects 18 years or older
• Subjects with any upper extremity injury or ailment that would require the use of a tourniquet while doing surgery
• Subject undergoing surgery by one of the six fellowship trained Orlando Health upper extremity surgeons previous listed
• Subject without prior surgery to the operative extremity

You may not qualify if:

• Subject under the age of 18 at the time of consent/enrollment
• Subject has had previous surgical procedures at the surgery site
• Subject with bleeding disorder comorbidities
• Subjects who have tourniquet released and then re-inflated during their procedure
• Subjects who do not have English as their preferred language and require an interpreter.

Sponsors & Collaborators

• Orlando Health, Inc.: lead

Study Sites (1)

Orlando Health Jewett Orthopedic Institute

Orlando, Florida, 32806, United States

Location

Related Publications (3)

• Zhang P, Liang Y, He J, Fang Y, Chen P, Wang J. Timing of tourniquet release in total knee arthroplasty: A meta-analysis. Medicine (Baltimore). 2017 Apr;96(17):e6786. doi: 10.1097/MD.0000000000006786.

  PMID: 28445317 BACKGROUND

• Fitzgibbons PG, Digiovanni C, Hares S, Akelman E. Safe tourniquet use: a review of the evidence. J Am Acad Orthop Surg. 2012 May;20(5):310-9. doi: 10.5435/JAAOS-20-05-310.

  PMID: 22553103 BACKGROUND

• Kam PC, Kavanagh R, Yoong FF. The arterial tourniquet: pathophysiological consequences and anaesthetic implications. Anaesthesia. 2001 Jun;56(6):534-45. doi: 10.1046/j.1365-2044.2001.01982.x.

  PMID: 11412159 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: June 2, 2022
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)