| CTRI Number |
CTRI/2022/12/048403 [Registered on: 22/12/2022] Trial Registered Prospectively |
| Last Modified On: |
21/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two local anaesthetic drugs for pain relief after LSCS with help of nerve block. |
|
Scientific Title of Study
|
Comparative analysis
of duration of post operative analgesia between bupivacaine versus ropivacaine in
ultrasound guided transverses abdominis plane block in patients undergoing lower segmental cesarean section: A prospective, randomised study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raghavendra Ullas L |
| Designation |
Post Graduate |
| Affiliation |
Rajarajeswari Medical college and Hospital |
| Address |
Department of Anaesthesiology,Rajarajeswari Medical College and Hospital,Mysore Road,Kambipura,Bangalore
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
9901884491 |
| Fax |
|
| Email |
ullasable@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudheer R |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Medical college and Hospital |
| Address |
Department of Anaesthesiology,Rajarajeswari Medical college and Hospital,Mysore Road,Kambipura,Bangalore
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
9741117754 |
| Fax |
|
| Email |
sudheerramegowda81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudheer R |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Medical college and Hospital |
| Address |
Department of Anaesthesiology,Rajarajeswari Medical college and Hospital,Mysore Road,Kambipura,Bangalore
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
9741117754 |
| Fax |
|
| Email |
sudheerramegowda81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Medical college and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Raghavendra Ullas L |
| Address |
Rajarajeswari Medical college and Hospital |
| Type of Sponsor |
Other [Self] |
|
|
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 Raghavendra Ullas L |
Rajarajeswari Medical college and Hospital |
Department of ANAESTHESIOLOGY Rajarajeswari Medical college and Hospital, Kambipura, Bangalore
Bangalore
KARNATAKA |
9901884491
ullasable@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
| Intervention |
TRANSVERSE ABDOMINIS PLANE BLOCK after the completion of surgery |
For Lower Segmental Cesarean Section, Patient will be followed up for 24 hours VAS score will be recorded every 2 hours and rescue analgesia will be given if VAS score is more than 4 . Time of first Rescue analgesia noted and comparing both the groups |
| Comparator Agent |
TRANSVERSE ABDOMINIS PLANE BLOCK after the completion of surgery |
Group A will be given TAP block after Surgery with Inj. Bupivacaine 0.25% 20ml bilaterally.
Group B will be given TAP block after Surgery with Inj. Ropivacaine 0.25% 20ml bilaterally.
Patient will be followed up for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA I to II Female patients.
2. Aged between 20 to 40 years.
3. Normal liver and renal function test, Coagulation profile.
4. Undergoing Lower Segment Caesarean Section Surgery under spinal anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Patients with history of allergy to local Anaesthetics.
2. Patients with history of mental disorders.
3. Patient Refusal.
4. Morbid obesity (BMI>40), Coagulopathy and significant cardiovascular respiratory, renal, hepatic or metabolic diseases or CNS disorders.
5. Infection at site of procedure. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the duration of Post operative analgesia using Bupivacaine (0.25%) and Ropivacaine (0.25%) in bilateral transversus abdominis plane block after spinal anaesthesia for lower segment cesarean section. |
To Note VAS score at 0,1, 2, 4, 8, 12, 16, 18 upto 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time of First rescue analgesia in minutes in both groups as noted by VAS score |
To Note VAS score at 0,1, 2, 4, 8, 12, 16, 18 upto 24 hours and note hemodynamic parameters |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/12/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Transversus abdominis plane (TAP) block is increasingly playing a role in postoperative analgesia for lower abdominal surgeries. It decreases opioid consumption and analgesic requirement with the benefits of reducing opioid side effects specially nausea, vomiting and also aids earlier ambulation and reduce number of days of hospital admission.In our study an effort has been made to compare duration post operative analgesia between Bupivacaine versus Ropivacaine in patients undergoing lower segmental cesarean section. |