Clinical trial NCT06576869: Timing of Tourniquet Release, A Prospective Randomized Trial
Official title: "Timing Of Tourniquet Release, A Prospective Randomized Trial"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury
Keywords: Tourniquet study
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.,

  * This includes type/dose of medication
  * Duration for taking the medication
  * Was the medication halted prior to surgery; if so, when
* Surgeon performing the surgery
* Surgical procedure
* Surgery location (ACC, 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analog pain scale
timeFrame: 2 weeks, 10 weeks and 6 months.
measure: Quick DASH form
timeFrame: 2 weeks, 10 weeks, 6 months.
measure: Hematoma assessment
timeFrame: 2 weeks, 10 weeks, 6 months.
measure: Satisfaction with surgery
timeFrame: 2 weeks, 10 weeks, 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health Jewett Orthopedic Institute
state: Florida
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.