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CTRI Number  CTRI/2023/03/050565 [Registered on: 10/03/2023] Trial Registered Prospectively
Last Modified On: 03/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparison of drugs for post operative pain relief in caesarean section 
Scientific Title of Study   Comparison of the Analgesic Efficacy of Wound Infiltration with Tramadol versus Bupivacaine for Postoperative Pain Relief in Caesarean Section under subarachnoid block: A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RUCHIKA KATHURIA 
Designation  Assistant Professor 
Affiliation  Maharaja Agrasen Medical College, Agroha, Hisar 
Address  Department of Anaesthesiology, Maharaja Agrasen Medical College,Agroha
Department of Anaesthesiology, Maharaja Agrasen Medical College, Agroha
Hisar
HARYANA
125001
India 
Phone  08053440544  
Fax    
Email  ruchikakathuria15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  VIBHA MEHTA 
Designation  Professor 
Affiliation  Maharaja Agrasen Medical College, Agroha, Hisar 
Address  Department of Anaesthesiology, Maharaja Agrasen Medical College,Agroha
Department of Anaesthesiology, Maharaja Agrasen Medical College, Agroha
Hisar
HARYANA
125001
India 
Phone  08053440544  
Fax    
Email  drvibhamehta1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  RUCHIKA KATHURIA 
Designation  Assistant Professor 
Affiliation  Maharaja Agrasen Medical College, Agroha, Hisar 
Address  Department of Anaesthesiology, Maharaja Agrasen Medical College, Agroha
Department of Anaesthesiology, Maharaja Agrasen Medical College, Agroha
Hisar
HARYANA
125001
India 
Phone  08053440544  
Fax    
Email  ruchikakathuria15@gmail.com  
 
Source of Monetary or Material Support  
Maharaja Agrasen Medical College, Agroha 
 
Primary Sponsor  
Name  Maharaja Agrasen Medical College, Agroha 
Address  Department of Anaesthesiology, Maharaja Agrasen Medical College, Agroha 
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 
Ruchika Kathuria  Maharaja Agrasen Medical College  Main Operation Theatre Complex, Post--operative Anaesthesia Care Unit, Post-operative obstetric ward.
Hisar
HARYANA 
8053440544

ruchikakathuria15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research, Maharaja Agrasen Medical College, Agroha, Hisar, Haryana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z488||Encounter for other specified postprocedural aftercare, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Administration of either tramadol or bupivacaine  Prophylactic wound infiltration with either tramadol or bupivacaine. Inj.Tramadol hydrochloride 2 mg/kg in 20 mL of 0.9% normal saline, Inj. Bupivacaine 20 mL of 0.25% isobaric bupivacaine. 
Comparator Agent  Drugs used are Tramadol and Bupivacaine  Comparison of Tramadol versus Bupivacaine for Postoperative Pain Relief for 24 hours in Caesarean Section. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. American Society of Anaesthesiologists’ physical status II.
2. Patients undergoing caesarean section under subarachnoid block. 
 
ExclusionCriteria 
Details  Patients
1. who refuse to give consent
2. with severe cardiopulmonary, renal or liver disease, pre-eclampsia, eclampsia, seizure disorder.
3. with contraindication to spinal anaesthesia like local site infections, coagulopathies or any spinal deformities.
4. who have infection at surgical site.
5. with history of allergy or hypersensitivity to local anaesthetics
6. with psychiatric illness that would interfere with assessment of pain will be excluded from the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison between the analgesic efficacy of wound infiltration with tramadol and bupivacaine for postoperative pain using NRS and time of rescue analgesia.  Assessment of post operative pain and time of rescue analgesia for upto 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of adverse events.  24 hours post operative. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   24/03/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT APPLICABLE 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Caesarean section is one of the most frequently performed surgeries in obstetrics. Optimal pain relief of the mother results in early mobilization and initiation of breast feeding. Multimodal analgesia is expected to provide high quality analgesia. Different methods such as drugs [nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, corticosteroids], and peroperative local anaesthetic infiltration have been used to reduce pain. Subcutaneous administration of opiates is a method of postoperative pain control after caesarean section. In our study, we aim to compare the analgesic efficacy of wound infiltration with tramadol versus bupivacaine for postoperative pain relief in caesarean section under subarachnoid block. A total of 80 patients will be randomly allocated into 2 groups with 40 patients in each group. Patients belonging to group T will receive tramadol hydrochloride 2 mg/kg in 20 mL of 0.9% normal saline while those belonging to group B will receive 20 mL of 0.25% isobaric bupivacaine. In the postanesthesia care unit (PACU) and ward, pain will be assessed using a Numerical Rating Scale. Incidence of side-effects such as nausea, vomiting, and shivering will be noted. The consumption of ondansetron and the rescue analgesics (Diclofenac and Paracetamol) over the first 24 h following surgery will be noted. Thereafter, comparisons will be made among the two groups based on the data collected. The different variables and occurrence of side effects, if any, would also be noted and compared amongst all groups. Since this is a randomized prospective trial, the anticipated outcome cannot be commented upon.

 
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