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

Lidocaine Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04692896
• Other study ID #: 27/RC/KEMU
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: December 2020
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lidocaine

Intervention

Drug:
• lidocaine
different concentrations of lidocaine with same concentration of adrenaline

Locations

Country	Name	City	State
Pakistan	Department of plastic Surgery,Mayo Hospital King Edward Medical University	Lahore	Pujab

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.