Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh

Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh: A Randomized Control Trial

Investigator is studying the effects of Lidocaine and Adrenaline Soaked Gauze vs Normal Saline Soaked Gauze at Skin Graft Donor Site of Thigh.

Haemostatic effect, epithelization and post operative pain will be assessed on follow up.

Study Overview

• Status: Completed
• Conditions: Non-healing Wound
• Intervention / Treatment: Drug: 2% Lidocaine and 1:100,000 Adrenaline; Drug: Normal saline

Detailed Description

After admission participants will be randomized either to be in Group A or Group B. Closed envelop technique will be used for random assignment of the patients.

Group A will be receiving 2% lidocaine and 1:100,000 adrenaline soaked gauze while group B will be given only normal saline soaked gauze at donor-site for ten minutes.

The primary end point of study is intraoperative bleeding. The secondary end points of study include no. of dressings required in first 24 hours after surgery, donor site epithelization at 14th post-operative day, post-operative pain in first 24 hours after surgery along with systemic analgesia requirement after surgery.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Zaara Zahid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Patients of both the gender of age > 15 years

  • Multiple donor-sites

Exclusion Criteria:

Bleeding disorder

• Concomitant injuries
• Donor site other than thigh
• Previously harvested donor-site
• Patients on antiplatelet medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A ( Lidocaine + Adrenaline); Group A patients will receive 2% Lidocaine and 1:100,000 adrenaline soaked gauze over skin graft donor site of thigh per operatively for 10 minutes. After 10 minutes this dressing will be removed and sufratul dressing will be applied over donor site.	Drug: 2% Lidocaine and 1:100,000 Adrenaline; Topical application of 2% Lidocaine and 1:100,000 Adrenaline in the form of dressing will be applied over skin graft donor site of thigh for 10 minutes.
Placebo Comparator: Group B ( Normal Saline); Group B patients will receive normal saline soaked gauze over skin graft donor site of thigh intraoperatively for 10 minutes. After 10 minutes this dressing will be removed and sufratul dressing will be applied over donor site	Drug: Normal saline; Topical application of Normal saline will be applied over skin graft donor site of thigh as a control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra operatieve bleeding	Intra-operative Bleeding from donor site of graft will be assessed per operatively as being normal or more than normal.	per operative
Post operative bleeding	post operative bleeding will be assesd in post operative period by number of dressings required.	24 hours
Post operative pain	post operative pain will be assessed in the post operative period by visual analog score. Score ranges from 0 to 10 with 0 indicating no pain whereas 10 is worst pain.	24 hours
Analgesia requirement	Post operative analgesia requirement of patient will be observed by number of medications required	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epithelization of donor site	Epithelization over donor site will be assessed on 14th post operative day by subjective assesment	14 days

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Publications and helpful links

General Publications

• Gacto P, Miralles F, Pereyra JJ, Perez A, Martinez E. Haemostatic effects of adrenaline-lidocaine subcutaneous infiltration at donor sites. Burns. 2009 May;35(3):343-7. doi: 10.1016/j.burns.2008.06.019. Epub 2008 Oct 23.

Helpful Links

• Gacto P, Miralles F, Pereyra J, Perez A, Martinez E. Haemostatic effects of adrenaline-lidocaine subcutaneous infiltration at donor sites. Burns. 2009;35(3):343-7.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): June 10, 2020
• Study Completion (Actual): June 10, 2020

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 7, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: 1506

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No