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CTRI Number  CTRI/2025/01/079185 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 19/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to see the impact of lidocaine patch on pain relief after caesarean section. 
Scientific Title of Study   Efficacy of Lidocaine patch for postoperative pain relief after caesarean section: A double-blinded randomized controlled trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Purnaa Mandal 
Designation  Junior resident 
Affiliation  All India Institute of Medical Sciences Patna 
Address  B5A OT Complex IPD building Department of Anaesthesiology All India Institute of Medical Sciences Patna Phulwarisharif Patna BIHAR India

Patna
BIHAR
801505
India 
Phone  7980271715  
Fax    
Email  purnaamandal98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kunal Singh 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Room no. 501 B5A OT Complex IPD building Department of Anaesthesiology All India Institute of Medical Sciences Patna Phulwarisharif Patna BIHAR India

Patna
BIHAR
801507
India 
Phone  9411514945  
Fax    
Email  drsinghkunal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kunal Singh 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Room no. 501 B5A OT Complex IPD building Department of Anaesthesiology All India Institute of Medical Sciences Patna Phulwarisharif Patna BIHAR India

Patna
BIHAR
801507
India 
Phone  9411514945  
Fax    
Email  drsinghkunal@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, 5th Floor IPD, All India Institute of Medical Sciences Patna, Bihar- 801507, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Patna 
Address  All India Institute of Medical Sciences Patna, Phulwarisharif, Patna, Bihar, PIN 801507 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Purnaa Mandal  All India Institute of Medical Sciences Patna  Department of Anaesthesiology,5th Floor IPD building, All India Institute of Medical Sciences Patna, Phulwarisharif
Patna
BIHAR 
7980271715

purnaamandal98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences Patna Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Adhesive bandage tape of similar shape and size applied on either side of surgical wound with 1 cm margin , in a sterile manner. 
Intervention  Lidocaine patch group  700mg lidocaine patch cut in 2 halves (350 mg each) applied topically on either side of surgical wound with 1 cm margin 12 hourly for 36 hours, in a sterile manner.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Women between 18 years to 40 years of age.
Scheduled for elective cesarean section.
American Society of Anesthesiologist physical status 2.
Gestational age more than 32 weeks.
Body Mass Index (BMI) less than or equal to 30. 
 
ExclusionCriteria 
Details  Known allergy or hypersensitivity to lidocaine or any component of the lidocaine patch.
Pre-existing chronic pain conditions.
Contraindication for neuraxial anaesthesia.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the analgesic effects of a 5% lignocaine patch compared to placebo patch in reducing postoperative pain intensity among women undergoing elective cesarean section deliveries using Numerical rating scale  At 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the analgesic effects of a 5% lignocaine patch compared to placebo patch in reducing postoperative pain intensity among women undergoing elective cesarean section deliveries using Numerical Rating Scale.   at 2, 6, 12 and 36 hours. 
The administration of a 5% lignocaine patch will result in reduced opioid consumption compared to conventional intervention among women undergoing cesarean section deliveries.  At 24 hours 
To find out patient’s impact on sleep due to pain using Daily Sleep Interference Scale .  At 24 hours 
To find out the incidence of post operative nausea and vomiting with the use of 5% lidocaine patch using 4-point rating .  At 24 hours 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/02/2025 
Date of Study Completion (India) 19/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Lidocaine is a local anaesthetic of the amide type which stabilises excitable membranes by inactivation of sodium channels. Its action on neuronal membranes prevents neuronal conduction. When applied topically in the form of patch, lidocaine produces a local analgesic effect. Lignocaine patch has a dual mode of action: the pharmacological action of lidocaine diffusion and the mechanical action of the hydrogel patch that protects the hypersensitive area. The lidocaine contained in the patch diffuses continuously into the skin, providing a local analgesic effect.

Caesarean section deliveries are one of the most common surgical procedures worldwide, offering a safe alternative for childbirth in cases where vaginal delivery poses risks to the mother or the baby.  Inadequate pain relief not only diminishes the mother’s comfort but also impedes her ability to care for her newborn and recover swiftly. For pain control use of opioid can be a major risk factor for PONV and post-operative sedation. The use of 5% lignocaine patch may contribute to lesser analgesic consumption and early recovery in mothers  undergoing caesarean section delivery under spinal anaesthesia.

This study aims to evaluate the potential postoperative analgesic effects of the 5% lignocaine patch in women undergoing cesarean section under spinal anesthesia and it’s utility as a valuable adjunct in the multimodal approach to postoperative pain management.

 
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