Clinical trial NCT03914235: Anesthesia Tumescent for Surgical Management of Tenosynovitis.
Official title: Efficacy of Tumescent Local Anesthesia in the Surgical Management of Tenosynovitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tenosynovitis
Keywords: Tumescent anesthesia
tenosynovitis
Visual Analog Scale
Tourniquets
Epinephrine
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2019-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness of the tumescent anesthesia technique in the surgical management of hand tenosynovitis. For this, an open clinical trial was conducted, which included patients with hand tenosynovitis (carpal tunnel syndrome, trigger finger and Quervain syndrome), which were randomly assigned to a group. The control group was released pulleys and ligaments with local anesthetic technique and hemostasis with pneumatic tourniquet; While the study group was released from the pulleys and ligaments with tumescent anesthesia. The study variables were: anesthesia time, trans-surgical bleeding, pain, total procedure time and tissue reperfusion time.

Detailed description: Introduction: The WALANT technique (Wide Awake Local Anesthesia No-Torniquet) proposes the use of local anesthesia, epinephrine and tourniquet in the areas of the hand to be repaired, making costs and time and comfort more efficient.

Objective: Evaluation of the effectiveness of the WALANT technique versus regional anesthesia with tourniquet in pain control, surgical management of stenosing tenosynovitis.

Material and methods: Open clinical trial including patients with the trigger finger, tunnel syndrome in the operating room, candidates for surgery, and excluding previous surgeries at the site of the injury, hemodynamic instability, peripheral vascular diseases, smoking, anxiety, or psychiatric diseases. The anesthetic method was applied to the incision sites according to the diagnosis and the proposed procedure. At the end of the test, tumescent solution and control, 1% lidocaine plus pneumatic tourniquet on the forearm at 250mmHg. The main variables were: type of anesthesia and pain during the procedure. Descriptive and inferential statistics were applied (xi2, t-student or Mann-Whitney U).

Eligibility criteria: Inclusion Criteria:

* Right holders of the Mexican Social Security Institute
* Over 18 years
* Trigger Finger Diagnosis
* Diagnosis of Carpal Tunnel Syndrome
* Diagnosis of Quervain Syndrome
* Acceptance and signature of informed consent

Exclusion Criteria:

* Necessity for concomitant surgery
* Previous surgeries on the injured site
* Hemodynamic instability
* History of peripheral vascular diseases
* Do not wish to participate in the study
* Hypersensitivity to medication
* Smoking

Primary outcomes:
measure: Procedure pain: Visual Analog Scale
timeFrame: immediate post surgery
Secondary outcomes:
measure: Bleeding
timeFrame: immediate post surgery
measure: Anesthesia application time
timeFrame: at the beginning of the application of anesthesia
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Western Medical Center, Mexican Institute of Social Security
state: Jalisco
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Clotilde Fuentes Orozco, PhD
role: PRINCIPAL_INVESTIGATOR
References: