| 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
|
|
|
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
|
|
|
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. |