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

NCT ID: NCT04692896

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lidocaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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0.1% lidocaine

Group Type EXPERIMENTAL

lidocaine

Intervention Type DRUG

different concentrations of lidocaine with same concentration of adrenaline

0.2% lidocaine

Group Type EXPERIMENTAL

lidocaine

Intervention Type DRUG

different concentrations of lidocaine with same concentration of adrenaline

0.3% lidocaine

Group Type EXPERIMENTAL

lidocaine

Intervention Type DRUG

different concentrations of lidocaine with same concentration of adrenaline

Interventions

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lidocaine

different concentrations of lidocaine with same concentration of adrenaline

Intervention Type DRUG

Other Intervention Names

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adrenaline

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Edward Medical University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Mustehsan Bashir

Professor of Plastic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of plastic Surgery,Mayo Hospital King Edward Medical University

Lahore, Pujab, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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27/RC/KEMU

Identifier Type: -

Identifier Source: org_study_id

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