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CTRI Number  CTRI/2025/02/080870 [Registered on: 19/02/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Pain Relief After C-Section between Injected drug and Nerve Block . 
Scientific Title of Study   ANALGESIC EFFICACY OF ERECTOR SPINAE PLANE BLOCK COMPARED WITH INTRATHECAL MORPHINE AFTER ELECTIVE CESAREAN SECTION A RANDOMISED DOUBLE BLIND STUDY  
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 K SWETHA 
Designation  JUNIOR RESIDENT 
Affiliation  MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  MAHATMA GANDHI MEDICAL COLLEGE SRI BALAJI VIDYAPEETH PILLAYARKUPPAM PUDUCHERRY


TAMIL NADU
607402
India 
Phone  08073101188  
Fax    
Email  drswethaind@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR RANI P  
Designation  PROFESSOR 
Affiliation  MGMCRI 
Address  MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE, SRI BALAJI VIDYAPEETH PILLAYARKUPPAM PUDUCHERRY

Pondicherry
PONDICHERRY
607402
India 
Phone  9443116908  
Fax    
Email  anaesrani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DRKSWETHA 
Designation  JUNIOR RESIDENT  
Affiliation  MGMCRI 
Address  MAHATMA GANDHI MEDICAL COLLEGE SRI BALAJI VIDYAPEETH PILLAYARKUPPAM PUDUCHERRY


TAMIL NADU
607402
India 
Phone  08073101188  
Fax    
Email  drswethaind@gmail.com  
 
Source of Monetary or Material Support  
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE SRI BALAJI VIDYAPEETH PILLAYARKUPPAM PUDUCHERRY 607402 
 
Primary Sponsor  
Name  MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  MAHATMA GANDHI MEDICAL COLLEGE SRI BALAJI VIDYAPEETH PILLAYARKUPPAM PUDUCHERRY 607402  
Type of Sponsor  Research institution and hospital 
 
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 
DrKSwetha  MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE  DEPARTMENT OF ANAESTHESIOLOGY, SECOND FLOOR, MAIN OT COMPLEX, SRI BALAJI VIDYAPEETH PILLAYARKUPPAM PUDUCHERRY 607402
Pondicherry
PONDICHERRY 
08073101188

drswethaind@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bilateral erector spinae block at the level of T 10 with 0.2 ml per kg of 0.25 % Bupivacaine  Surgery will conducted with Hyperbaric bupivacaine 0.5 % 12mg and following surgery bilateral erector spinae block will be performed at the level of T10 with 0.2 ml per kg of 0.25 % Bupivcaine  
Comparator Agent  Spinal Anaesthesia with Morphine as adjuvant   intrathecal bupivacaine heavy 12mg with 100mcg morphine at L3-L4 or L4-L5 space before surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  • Age between 18-40 years
• Elective LSCS with no fetal compromise.
 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA
Pregnancy induced hypertension
Bleeding disorder
Morbid obesity
H/o OSA
H/o Allergies to Local Anaesthetics
H/o Bronchial Asthma
Fetal distress
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the Visual Analog Score at 4 hours interval in the post op period for 1st 24 hours.  Pain score seen post operatively  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the time for first analgesic request.
To assess the incidence of pruritis, nausea and vomiting in both the groups.
To assess the parturient satisfaction regarding post op analgesia.
To assess the Haemodynamics for the first 24 hours .
 
 
The parameters are assesed over a period of 24 hours 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

 

This randomized, prospective, double-blind study will be conducted in Mahatma Gandhi Medical College and Research Institute between June 2024 and Dec 2025. Prospective parturients who are posted for elective and emergency LSCS with no fetal compromise under spinal anaesthesia will be the study population.

Inclusion criteria: age between 18-40years, scheduled for elective and emergency cesarean section, American society of Anesthesiologist physical status II emergency LSCS with indication of previous LSCS.

Exclusion criteria: Pregnancy induced hypertension, bleeding disorder, morbid obesity, H/O OSA, H/O allergies to local anaesthetics, H/O bronchial asthma, fetal distress.

Sample size is calculated using statistics and sample size (BIOSTATVN) android application (Author - Mr. Thai thanh true version 1). Based on study by Mohammed Ahmed Hamed et al, with recommended dose of 0.2ml/kg of 0.25% Bupivacaine the pain score will be equivalent to intrathecal morphine at 8 hours of postoperative period. A minimal sample size of 64 is required in each group for a power of 0.80, alpha level of 0.05 and a median effect size of 0.7, the required number of participants in each group is 33. To overcome the dropouts, the calculated sample size is increased  to reach 45 parturients in each group.

 Participants will be enrolled by means of consecutive sampling and they will be explained about the study and written informed consent will be obtained.

They will be randomly allocated into two equal groups (the ITM group as A or the ESPB group as B ) consecutively. The participants and data collectors will be unaware of group allocation until study completion. Preoperative investigations, including an electrocardiogram (ECG), complete blood count, renal function tests, and a coagulation profile, will be performed. All parturients will be advised nil per oral (NPO) for 8 hrs prior to the surgery. Upon arrival to the pre-operating room, intravenous (IV) access will be obtained (one 18G peripheral venous cannula). In the operating theatre the routine monitoring procedures (pulse oximetry, ECG, and non-invasive blood pressure monitoring) will be initiated. All parturients will receive 8 mg ondansetron intravenously as premedication, and 10 m/kg of Ringer’s lactate solution will be infused during the spinal procedure. With the parturient in sitting position or lateral position as per patient comfort the skin on the back was sterilized and 2 mL of 2% lidocaine will be then administered as a subcutaneous infiltration. Spinal anesthesia will be performed using a midline method into the L4-5 or L3-4 interspaces with a 25G Quincke spinal needle. After confirming free flow of the cerebrospinal fluid through the needle, 12 mg of 0.5% hyperbaric bupivacaine will be slowly introduced for those in the ESPB group; those in the ITM group received a spinal injection of 12 mg of hyperbaric 0.5% bupivacaine plus 100 mcg of preservative-free morphine. The patient will then immediately be moved to the supine position with a 15° left tilt and fitted with an oxygen mask. After confirming an adequate anesthesia level, the surgical procedure will be performed with continuous hemodynamic monitoring and recording. If the systolic blood pressure is  reduced to 20% below the baseline or less than 90 mmHg, 6 mg Mephenteramine will be administered intravenously. Moreover, if the heart rate slowed to 50 beats/min or less, 0.6 mg atropine will be administered intravenously. Upon delivery of the fetus, 10 units of oxytocin will be given by IV infusion. APGAR score of the baby will be noted. At the end of the cesarean section surgery, parturients in the ESPB group will receive ultrasound guided bilateral ESPB at the level of the ninth thoracic transverse process. Parturients turned to a lateral position, and the transducer was positioned vertically 3 cm to the side of the midline to visualize the muscles of the back, the transverse process, and the pleura among the two transverse processes. Then, after subcutaneous infiltration of 3 mL of 2% lidocaine, a 22G blunt needle will be introduced in the cranial-caudal direction toward the transverse process (T9) using the in-plane method till the needle tip crosses all the muscles. After ensuring negative aspiration, interfascial injection of 0.2ml/kg mL of 0.25% bupivacaine will be performed. The procedure will be repeated on the opposite side of the back. Sham blocks will be used for participants in the ITM group; the sham blocks involved a non-invasive ultrasound scan, and a short bevel needle was gently pressed on both sides. We will instruct the participants to report any signs of local anesthetic toxicity throughout the injection procedure (eg, change in mental status, anxiety, oral numbness, and ringing in the ears). For all participants, spinal level will be assessed and recorded before the block. At the end of the cesarean section, parturients will be transported to a postoperative anesthesia care unit (PACU), and the routine monitoring procedures will be followed. Any intraoperative or postoperative nausea or vomiting will be managed with 10 mg metoclopramide. All participants will receive 30 mg ketorolac intravenously at the time of the ESPB or sham blocks. Participants will be transferred to the obstetrics ward when they attained a modified Aldrete score ≥9. Throughout the first 24 hrs, patients will receive IV paracetamol 1 g every 8 hrs for postoperative analgesia. Postoperative mean arterial blood pressure, postoperative pulse rate, and postoperative visual analogue scale (VAS) pain score (ranging from 0 to 10, where 0 indicated no pain and 10 indicated maximum pain) will be measured at rest and with cough. All of these parameters will be assessed upon arrival in the PACU and at 4, 8, 12, 16, and 24 hrs. The total tramadol intake in 24 hrs and the time to the first analgesic request will be noted. Participant satisfaction will be assessed on a 4-point scale (1: excellent, 2: good 3: fair, 4: poor). Adverse effects included nausea and vomiting (0 = no symptoms, 1 = only nausea, 2 = nausea and vomiting), respiratory depression (respiratory rate less than 10), sedation (0 = awake and alert, 1 = quietly awake, 2 = asleep but easily arousable, 3 = deep sleep, responding to painful stimulus), and pruritus (1 = no pruritus, 2 = mild pruritus, 3 = moderate pruritus, 4 = severe pruritus). The data collector will be blinded to group distribution. The primary outcome of our study will be the severity of pain, measured using the VAS score 8 hrs after the surgery during rest. Secondary outcomes are the total tramadol intake, VAS score at other postoperative time points (upon arrival to the PACU and 4, 8, 12, and 24 hrs after surgery), the time to the first analgesic request, participant satisfaction, and any side effects or complications.

Statistical analysis will be carried out using SPSS version 20.0 (IBM SPSS, US) software with Regression Modules installed. Descriptive analyses were reported as mean and standard deviation of continuous variables

 

 

 
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