| CTRI Number |
CTRI/2020/09/027583 [Registered on: 03/09/2020] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| 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
|
EFFECT OF DEXMEDETOMIDINE WITH BUPIVACAINE VERSUS BUPIVACAINE ALONE IN BILATERAL QUADRATUS LUMBORUM BLOCK FOR POST OPERATIVE ANALGESIA AFTER CAESAREAN DELIVERY |
|
Scientific Title of Study
|
EFFECT OF DEXMEDETOMIDINE AS AN ADJUVANT TO BUPIVACAINE VERSUS BUPIVACAINE ALONE IN BILATERAL QUADRATUS LUMBORUM BLOCK FOR POST OPERATIVE ANALGESIA AFTER CAESAREAN DELIVERY –
A PROSPECTIVE RANDOMISED DOUBLE BLINDED STUDY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varun KaruppiahT |
| Designation |
Post graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room no 119, G block, Mens hostel
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai
Department of Anaesthesiology and Pain Medicine
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9884039276 |
| Fax |
|
| Email |
varunk1495@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh Kumar Kodali |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Staff Quarters
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai
Department of Anaesthesiology and Pain Medicine
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9444230150 |
| Fax |
|
| Email |
vrajesh.kodali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varun KaruppiahT |
| Designation |
Post graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room no 119, G block, Mens hostel
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai
Department of Anaesthesiology and Pain Medicine
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9884039276 |
| Fax |
|
| Email |
varunk1495@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Varun Karuppiah T |
| Address |
Room no 119, G block, Mens hostel
Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Varun KaruppiahT |
Department of Anaesthesiology and Pain Medicine |
Sri Ramachandra Institute of Higher Education and Research,
Porur, chennai 600116
Chennai
TAMIL NADU |
9884039276
varunk1495@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: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine alone in Bilateral Quadratus Lumborum Block post Caesarean delivery |
Post op analgesic efficacy of Bupivacaine alone in Bilateral Quadratus Lumborum Block post Caesarean delivery |
| Intervention |
Dexmedetomidine added to Bupivacaine in Bilateral Quadratus Lumborum Block post Caesarean Delivery |
To assess the post op analgesic efficacy of addition of dexmedetomidine to Bupivacaine in Bilateral Quadratus Lumborum Block post Caesarean Delivery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy, gestation age of at least 37 weeks, undergoing Caesarean section under spinal anesthesia of ASA grades 2 |
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Age <18 or >45 years
3. BMI >32
4. Allergy to local anesthesic agents
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to initial onset of pain (VAS 4) and time to first rescue analgesia |
0 mins
30 mins
1 hr
2 hrs
4hrs
8hrs
12hrs
16hrs
20hrs
24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of rescue analgesia used |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/09/2020 |
| Date of Study Completion (India) |
31/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Quadratus Lumborum block (QLB) is an abdominal truncal block used
for somatic analgesia of both the upper and lower abdomen. The more posterior QLB
provide superior local anaesthetic spread to the para vertebral space and
sympathetic nerves in the thorocolumbar fascia. The wider spread of the local
anaesthetic agents produce extensive post-operative analgesia which has been
proven in Caesarean deliveries.
The effect of Dexmedetomidine as an
adjuvant with local anaesthetic has not been extensively studied in QLB,
whereas the same has been shown to prolong the duration of analgesia in
Transversus Abdominis Plane (TAP) block.
In this prospective, randomized study, we aimed to compare
bilateral quadratus lumborum block with dexmedetomidine and bupivacaine versus
bupivacaine alone for post- operative analgesia after caesarean delivery. |