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Completed

NCT Number: NCT04692896

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

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.

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Key information

Conditions

Lidocaine

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of plastic Surgery,Mayo Hospital King Edward Medical University

Lahore, Pujab, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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 .
  • Surgical site infection .
  • History of allergic hypersensitivity to epinephrine or lidocaine.

Treatment and study plan

Lidocaine

Drug

different concentrations of lidocaine with same concentration of adrenaline

Other names: adrenaline

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2021
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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