Effect of Different Concentrations of Lidocaine in Relieving Pain in Wide Awake Hand Surgery Using Tumescence
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedFirst Submitted
Initial submission to the registry
December 27, 2020
CompletedFirst Posted
Study publicly available on registry
January 5, 2021
CompletedJanuary 5, 2021
December 1, 2020
7 months
December 27, 2020
December 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
total duration of analgesia
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.
Study Arms (3)
0.1% lidocaine
EXPERIMENTAL0.2% lidocaine
EXPERIMENTAL0.3% lidocaine
EXPERIMENTALInterventions
different concentrations of lidocaine with same concentration of adrenaline
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of plastic Surgery,Mayo Hospital King Edward Medical University
Lahore, Pujab, 54000, Pakistan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Plastic Surgery
Study Record Dates
First Submitted
December 27, 2020
First Posted
January 5, 2021
Study Start
September 1, 2017
Primary Completion
March 31, 2018
Study Completion
March 31, 2018
Last Updated
January 5, 2021
Record last verified: 2020-12