Timing of Tourniquet Release

"Timing Of Tourniquet Release, A Prospective Randomized Trial"

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.

Study Overview

• Status: Completed
• Conditions: Injury
• Intervention / Treatment: Procedure: Upper extremity orthopedic surgeries.

Detailed Description

Patients will be enrolled prior to surgery and consented to participate in the study [HPJ2]. Patients will be enrolled by the research staff with a provider including attending and resident surgeons as well as advanced practiced providers that are assigned to the upper extremity team. A computerized random number generator will be used to randomize patient allocation to either study arm: closure without releasing the tourniquet vs releasing the tourniquet and then closing the incision. Randomization will occur at the time of surgery. In order to standardize the procedure a 4-inch ace wrap will be wrapped around the upper arm and a tourniquet will be placed over this in order to ensure adequate padding [HPJ3] [AW4]. At the conclusion of the surgical procedure but prior to skin closure, the randomized number will be revealed to the surgeon and the surgeon will either release the tourniquet or will keep the tourniquet inflated and then close the skin. After the surgery is completed, information will be collected on the intraoperative data collection form to include: • Length and exact location of incision• Whether the patient is on anticoagulant medication., o This includes type/dose of medicationo Duration for taking the medicationo Was the medication halted prior to surgery; if so, when• Surgeon performing the surgery• Surgical procedure• Surgery location (Ambulatory Care Center (ACC), Orlando Regional Medical Center (ORMC), etc.) • When tourniquet is dropped (before/after closure)• Tourniquet Time• Time from tourniquet release to closure• Total Surgical time (time from incision until complete skin closure) • Turnover time• Was electrocautery required to control any bleeding; if so, what type and what was electrocauterized? Clinical outcome measures collected during postoperative follow up. • Visual analog pain scale• Quick Disability of the Arm, Shoulder and Hand (DASH) form• Complications including hematoma size• Satisfaction with treatment (scale 1-5)o completely satisfied - 5, somewhat satisfied - 4, neither satisfied or dissatisfied - 3, partly dissatisfied - 2, completely dissatisfied - 1• Likely to recommend this surgery to a friend family member who has the same condition - yes or no Patients enrolled in the study will follow up in clinic at the following time intervals: 2 weeks, 10 weeks, and 6 months per standard of care.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health Jewett Orthopedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A: Closure without releasing the tourniquet.; Tourniquet is dropped after closure.	Procedure: Upper extremity orthopedic surgeries.; Upper extremity orthopedic surgeries that require the use of a tourniquet.
Active Comparator: B: Releasing the tourniquet and then closing the incision; Tourniquet is dropped prior to closure.	Procedure: Upper extremity orthopedic surgeries.; Upper extremity orthopedic surgeries that require the use of a tourniquet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Orlando Health, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Actual): May 9, 2023
• Study Completion (Actual): May 9, 2023

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Tourniquet study
• Other Study ID Numbers: 22.028.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In order to protect the rights of our study participants, protected heath information will not be identified or shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No