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

Phase 1

Completed

• Conditions: Lidocaine
• Interventions: Drug: lidocaine

• Registration Number: NCT04692896
• Lead Sponsor: King Edward Medical University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Status Verified: 2020-12
• Study First Submitted: 2020-12-27
• Study First Submitted QC: 2020-12-31
• Last Update Submitted: 2020-12-31
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.1% lidocaine	lidocaine	-
0.2% lidocaine	lidocaine	-
0.3% lidocaine	lidocaine	-

Primary Outcome Measures

Name	Time	Method
total duration of analgesia	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.

Trial Locations

Locations (1)

Department of plastic Surgery,Mayo Hospital King Edward Medical University; 🇵🇰 Lahore, Pujab, Pakistan