Anesthesia Tumescent for Surgical Management of Tenosynovitis.

Sponsor

Instituto Mexicano del Seguro Social (Other)

Overall Status

Completed

CT.gov ID

NCT03914235

Collaborator

(none)

Enrollment

Location

Arms

8.2

Actual Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tenosynovitis	Combination Product: Tumescent Anesthesia Drug: Lidocaine Device: Pneumatic tourniquet Procedure: Open release of the tendon	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of Tumescent Local Anesthesia in the Surgical Management of Tenosynovitis.

Actual Study Start Date :

Aug 1, 2018

Actual Primary Completion Date :

Mar 31, 2019

Actual Study Completion Date :

Apr 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tumescent anesthesia A tumescent solution was prepared; consisting of 40 cc of 0.9% Saline Solution, 10 cc of 2% Lidocaine, 0.4 cc of Epinephrine (1: 1000) and 4 cc of 7.5% Sodium Bicarbonate. This solution was applied in the incision sites according to the diagnosis and the proposed procedure. In case of trigger finger, 3 cc was applied subcutaneously in the proximal palmar crease of the affected finger; for Quervain syndrome, 5 to 6 cc of tumescent solution was injected along the first extensor compartment at the radial styloid level; and in the case of Carpal Tunnel Syndrome, 10 cc of tumescent solution was infiltrated on the flexor retinaculum in the subcutaneous tissue and from 7 to 10 cc below it. Subsequently, 20 minutes were waited for the epinephrine to cause vasoconstriction, and the asepsis of the limb was continued , sterile fields were placed, the incision site was corroborated and the surgical procedure proposed for each pathology was started.	Combination Product: Tumescent Anesthesia A tumescent solution is prepared with 2% lidocaine (10ml), 1:1000 epinephrine (0.4ml) and 7.5% sodium bicarbonate (4ml) dissolved in 0.9% saline solution (40ml) and applied from 3 to 20ml (depending on the pathology to be repaired) at the incision site. Procedure: Open release of the tendon Standard surgical procedure for carpal tunnel syndrome, trigger finger and Quervain syndrome.
Active Comparator: Local anesthesia with tourniquet. Lidocaine 1% was applied to the incision sites according to the diagnosis and the proposed procedure. In case of trigger finger, 3 cc was applied subcutaneously in the proximal palmar crease of the affected finger; for Quervain syndrome, 5 to 6 cc were injected along the first extensor compartment at the radial styloid level; and in the case of Carpal Tunnel Syndrome, 10 cc was infiltrated on the flexor retinaculum in the subcutaneous tissue and from 7 to 10 cc below it. Afterwards, a pneumatic tourniquet was placed at the level of the forearm at 250 mmHg after exsanguination with a bandage from Esmarch. The asepsis of the limb was continued, sterile fields were placed, the incision site was corroborated and the surgical procedure proposed for each pathology was started. At the end of the surgical procedure, it was closed by planes, a soft bandage was placed, the tourniquet was removed and the patient was taken to recovery.	Drug: Lidocaine Apply 3 to 20 ml at the incision site, depending on the pathology to be repaired(carpal tunnel syndrome, trigger finger or Quervain syndrome). Other Names: Lidocaine 1% Device: Pneumatic tourniquet Level of the forearm at 250 mmHg, after exsanguination with Esmarch bandage. Procedure: Open release of the tendon Standard surgical procedure for carpal tunnel syndrome, trigger finger and Quervain syndrome.

Arm

Intervention/Treatment

Experimental: Tumescent anesthesia

A tumescent solution was prepared; consisting of 40 cc of 0.9% Saline Solution, 10 cc of 2% Lidocaine, 0.4 cc of Epinephrine (1: 1000) and 4 cc of 7.5% Sodium Bicarbonate. This solution was applied in the incision sites according to the diagnosis and the proposed procedure. In case of trigger finger, 3 cc was applied subcutaneously in the proximal palmar crease of the affected finger; for Quervain syndrome, 5 to 6 cc of tumescent solution was injected along the first extensor compartment at the radial styloid level; and in the case of Carpal Tunnel Syndrome, 10 cc of tumescent solution was infiltrated on the flexor retinaculum in the subcutaneous tissue and from 7 to 10 cc below it. Subsequently, 20 minutes were waited for the epinephrine to cause vasoconstriction, and the asepsis of the limb was continued , sterile fields were placed, the incision site was corroborated and the surgical procedure proposed for each pathology was started.

Combination Product: Tumescent Anesthesia

A tumescent solution is prepared with 2% lidocaine (10ml), 1:1000 epinephrine (0.4ml) and 7.5% sodium bicarbonate (4ml) dissolved in 0.9% saline solution (40ml) and applied from 3 to 20ml (depending on the pathology to be repaired) at the incision site.

Procedure: Open release of the tendon

Standard surgical procedure for carpal tunnel syndrome, trigger finger and Quervain syndrome.

Active Comparator: Local anesthesia with tourniquet.

Lidocaine 1% was applied to the incision sites according to the diagnosis and the proposed procedure. In case of trigger finger, 3 cc was applied subcutaneously in the proximal palmar crease of the affected finger; for Quervain syndrome, 5 to 6 cc were injected along the first extensor compartment at the radial styloid level; and in the case of Carpal Tunnel Syndrome, 10 cc was infiltrated on the flexor retinaculum in the subcutaneous tissue and from 7 to 10 cc below it. Afterwards, a pneumatic tourniquet was placed at the level of the forearm at 250 mmHg after exsanguination with a bandage from Esmarch. The asepsis of the limb was continued, sterile fields were placed, the incision site was corroborated and the surgical procedure proposed for each pathology was started. At the end of the surgical procedure, it was closed by planes, a soft bandage was placed, the tourniquet was removed and the patient was taken to recovery.

Drug: Lidocaine

Apply 3 to 20 ml at the incision site, depending on the pathology to be repaired(carpal tunnel syndrome, trigger finger or Quervain syndrome).

Other Names:

Lidocaine 1%

Device: Pneumatic tourniquet

Level of the forearm at 250 mmHg, after exsanguination with Esmarch bandage.

Procedure: Open release of the tendon

Standard surgical procedure for carpal tunnel syndrome, trigger finger and Quervain syndrome.

Outcome Measures

Primary Outcome Measures

Procedure pain: Visual Analog Scale [immediate post surgery]
Evaluated by Visual Analog Scale, A subjective psychometric response scale used to measure distinct behavioral or physiological phenomena based on linear numerical gradient, with values from 0 to 10. In the value 0 the absence or less intensity is located and in 10 the greater intensity of pain.

Secondary Outcome Measures

Bleeding [immediate post surgery]
Bleeding estimated in consensus between anesthesiologist and surgeon, based on the gauze used during surgery
Anesthesia application time [at the beginning of the application of anesthesia]
The interval of time in minutes that is required to apply the anesthetic method chosen in the area to be used

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Western Medical Center, Mexican Institute of Social Security	Guadalajara	Jalisco	Mexico	44340

Sponsors and Collaborators

Instituto Mexicano del Seguro Social

Investigators

Principal Investigator: Clotilde Fuentes Orozco, PhD, Instituto Mexicano del Seguro Social

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CLOTILDE FUENTES OROZCO, Investigador de tiempo completo, Instituto Mexicano del Seguro Social

ClinicalTrials.gov Identifier:

NCT03914235

Other Study ID Numbers:

R-2018-1301-021

First Posted:

Apr 16, 2019

Last Update Posted:

Apr 29, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by CLOTILDE FUENTES OROZCO, Investigador de tiempo completo, Instituto Mexicano del Seguro Social

Additional relevant MeSH terms:

Tenosynovitis

Lidocaine

Study Results

No Results Posted as of Apr 29, 2019