Effect of Different Concentrations of Lidocaine in Relieving Pain in Wide Awake Hand Surgery Using Tumescence

December 31, 2020 updated by: Muhammad Mustehsan Bashir, King Edward Medical University

Effect of Different Concentrations of Lidocaine in Relieving Pain Peroperatively and 24 Hours Postoperatively in Wide Awake Hand Surgery Using Tumescent Local Anesthesia Technique

Lidocaine has been used along with adrenaline in tumescent anesthesia for a variety of procedures. This has been quite popular especially in wide awake surgery of the hand with no tourniquet. However, the appropriate lidocaine concentration is yet to be established. This randomized control trial will study the minimum effective lidocaine concentration in hand surgery using the tumescent technique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Pujab
      • Lahore, Pujab, Pakistan, 54000
        • Department of plastic Surgery,Mayo Hospital King Edward Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients aged 16 to 60 years of either gender
  2. Patients with post burn/post traumatic contractures involving fingers & palm
  3. Patients with nerve injury or flexor/extensor tendons injury distal to mid forearm.

Exclusion Criteria:

  1. Patients with history of ischemic heart disease, chronic liver disease (ALT/AST 40 IU/L), renal disease (creatinine 13mg/dl), bleeding disorder, peripheral arterial disease & peripheral neuro3pathy .
  2. Surgical site infection .
  3. History of allergic hypersensitivity to epinephrine or lidocaine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.1% lidocaine
Drug: lidocaine
different concentrations of lidocaine with same concentration of adrenaline
Other Names:
  • adrenaline
Experimental: 0.2% lidocaine
Drug: lidocaine
different concentrations of lidocaine with same concentration of adrenaline
Other Names:
  • adrenaline
Experimental: 0.3% lidocaine
Drug: lidocaine
different concentrations of lidocaine with same concentration of adrenaline
Other Names:
  • adrenaline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total duration of analgesia
Time Frame: Within 24 hours of randomization.
Patients were randomized to either 0.1percent, 0.2 percent and 0.3 percent groups. Tumescent local anesthesia was infiltered. Surgery was started approximately 25 minutes after the infiltration. Start of surgery was designated 0 minute. Duration of pain free surgery was noted in minutes. Pain scores was measured after surgery. When pain scores was equal to or more than 4, analgesia was given and total time in minute from start of surgery till this time was taken as total duration of analgesia.
Within 24 hours of randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Edward Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

December 27, 2020

First Submitted That Met QC Criteria

December 31, 2020

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 31, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27/RC/KEMU

Drug and device information, study documents

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lidocaine

Clinical Trials on lidocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe