| CTRI Number |
CTRI/2021/07/035203 [Registered on: 28/07/2021] Trial Registered Prospectively |
| Last Modified On: |
27/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of post operative pain relief in cesarean delivery with buprenorphine and morphine when used along with 0.25%bupivacaine in ultrasound guided transversus abdominis plane block. |
|
Scientific Title of Study
|
Comparison of burprenorphine and morphine an adjuvant to 0.25% bupivacaine for post operative analgesia with ultrasound guided transversus abdominal plane block in cesarean delivery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M MUGUNDA RAJ |
| Designation |
PG student |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
No-109,1st floor,
Department of anaesthesiology,
Sri manakula vinayagar medical college and hospital,
Kalitheerthalkuppam,Madagadipet.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9894228804 |
| Fax |
|
| Email |
mugunthraj94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R KRISHNA PRABU |
| Designation |
Professor |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
No-109,1st floor,
Department of anaesthesiology,
Sri manakula vinayagar medical college and hospital,
Kalitheerthalkuppam,Madagadipet.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9943770977 |
| Fax |
|
| Email |
drkrishnaprabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M MUGUNDA RAJ |
| Designation |
PG student |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
No-109,1st floor,
Department of anaesthesiology,
Sri manakula vinayagar medical college and hospital,
Kalitheerthalkuppam,Madagadipet.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9894228804 |
| Fax |
|
| Email |
mugunthraj94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia,Sri manakula vinayagar medical college and hospital,605107 |
|
|
Primary Sponsor
|
| Name |
M MUGUNDA RAJ |
| Address |
N0-7,Ap quarters,sri manakula vinayagar medical college and hospital,pondicherry,605107 |
| 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 |
| M MUGUNDA RAJ |
Sri manakula vinayagar medical college and hospital |
No-109,
Department of anaesthesiology,
Sri manakula vinayagar medical college and hospital, kalitheerthalkuppam,
Madagadipet,
Pondicherry,605107
Pondicherry
PONDICHERRY |
9894228804
mugunthraj94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri manakula vinayagar medical college and hospital -Ethic 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 |
Morphine,
Bupivacaine |
Morphine (5mg) diluted to 15ml mixed with 0.5% bupivacaine 15ml, so the total mixture (30ml) containing 5mg morphine and 0.25% bupivacaine. 15ml of mixture is injected on the either side of Transverse abdominis muscle plane. |
| Intervention |
Buprenorphine,
Bupivacaine
|
Buprenorphine 150mcg diluted to 15ml mixed with 0.5% bupivacaine 15ml, so the total mixture (30ml) containing 150mcg buprenorphine and 0.25% bupivacaine.15ml of mixture is injected on the either side of Transverse abdominis muscle plane. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patient with ASA physical status-2 posted for cesarean delivery |
|
| ExclusionCriteria |
| Details |
1. Chronic pain disorder
2. Known allergy or hypersensitivity to the study drug
3. Coagulopathy
4.local infection at block site
5.patient refusal for the procedure |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative pain assessment (VAS score),
Heart rate,
Respiratory rate,
Blood pressure,
Oxygen saturation. |
All these parameters are measured every 15mins for 1st hour,then every hourly upto 12hours,Then every 4th hourly upto 24hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 24 hour analgesic consumption, nausea, vomiting, pruritis, |
Monitored for 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/08/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post operative pain in cesarean delivery is of utmost concern, inadequate pain relief may lead to Poor recovery and prolong hospital stay. Hence it require a multimodal approach, as transversus abdominis plane has extended course of subcostal, ilioinguinal, iliohypogatric and genitofemoral nerves.A transversus abdominis plane (TAP) block is more appropriate in lower abdominal surgeries.As blind injections can result in inadvertent injury to bowel or blood vessels using ultrasound guided transversus abdominis plane block is more is more appropriate. Bupivacaine has shown its efficacy in providing post operative analgesia for 6 to 8hours adding an adjuvant will prolong its effect.In this study we are about to compare the post operative analgesic effect of buprenorphine and morphine when added as adjuvant to 0.25% bupivacaine in ultrasound guided transversus abdominis plane block, in patient undergoing cesarean delivery. |