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Anesthesia Tumescent for Surgical Management of Tenosynovitis.

Primary Purpose

Tenosynovitis

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Tumescent Anesthesia
Lidocaine
Pneumatic tourniquet
Open release of the tendon
Sponsored by
Instituto Mexicano del Seguro Social
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tenosynovitis focused on measuring Tumescent anesthesia, tenosynovitis, Visual Analog Scale, Tourniquets, Epinephrine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Western Medical Center, Mexican Institute of Social Security

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tumescent anesthesia

Local anesthesia with tourniquet.

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Procedure pain: Visual Analog Scale
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
Bleeding estimated in consensus between anesthesiologist and surgeon, based on the gauze used during surgery
Anesthesia application time
The interval of time in minutes that is required to apply the anesthetic method chosen in the area to be used

Full Information

First Posted
April 11, 2019
Last Updated
April 25, 2019
Sponsor
Instituto Mexicano del Seguro Social
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1. Study Identification

Unique Protocol Identification Number
NCT03914235
Brief Title
Anesthesia Tumescent for Surgical Management of Tenosynovitis.
Official Title
Efficacy of Tumescent Local Anesthesia in the Surgical Management of Tenosynovitis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
April 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tenosynovitis
Keywords
Tumescent anesthesia, tenosynovitis, Visual Analog Scale, Tourniquets, Epinephrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tumescent anesthesia
Arm Type
Experimental
Arm Description
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.
Arm Title
Local anesthesia with tourniquet.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Tumescent Anesthesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Lidocaine 1%
Intervention Description
Apply 3 to 20 ml at the incision site, depending on the pathology to be repaired(carpal tunnel syndrome, trigger finger or Quervain syndrome).
Intervention Type
Device
Intervention Name(s)
Pneumatic tourniquet
Intervention Description
Level of the forearm at 250 mmHg, after exsanguination with Esmarch bandage.
Intervention Type
Procedure
Intervention Name(s)
Open release of the tendon
Intervention Description
Standard surgical procedure for carpal tunnel syndrome, trigger finger and Quervain syndrome.
Primary Outcome Measure Information:
Title
Procedure pain: Visual Analog Scale
Description
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.
Time Frame
immediate post surgery
Secondary Outcome Measure Information:
Title
Bleeding
Description
Bleeding estimated in consensus between anesthesiologist and surgeon, based on the gauze used during surgery
Time Frame
immediate post surgery
Title
Anesthesia application time
Description
The interval of time in minutes that is required to apply the anesthetic method chosen in the area to be used
Time Frame
at the beginning of the application of anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clotilde Fuentes Orozco, PhD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Medical Center, Mexican Institute of Social Security
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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Anesthesia Tumescent for Surgical Management of Tenosynovitis.

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