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
|
|
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
|
|
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. |