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Anesthesia Tumescent for Surgical Management of Tenosynovitis.

NCT03914235 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-04-29

No results posted yet for this study

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.

Conditions

  • Tenosynovitis

Interventions

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.

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).

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.

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    lead OTHER_GOV

Principal Investigators

  • Clotilde Fuentes Orozco, PhD · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-03-31
Completion
2019-04-08

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03914235 on ClinicalTrials.gov