| CTRI Number |
CTRI/2021/01/030289 [Registered on: 06/01/2021] Trial Registered Prospectively |
| Last Modified On: |
03/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF ANALGESIC EFFECT OF TRANSVERSUS ABDOMINIS PLANE BLOCK (MID-ABDOMEN) AND
QUADRATUS LUMBORUM PLANE BLOCK(LOWER BACK) FOR PAIN RELIEF AFTER CAESAREAN DELIVERY |
|
Scientific Title of Study
|
COMPARISON OF TRANSVERSUS ABDOMINIS PLANE BLOCK AND
QUADRATUS LUMBORUM PLANE BLOCK FOR POST OPERATIVE
ANALGESIA FOLLOWING CAESAREAN DELIVERY
A PROSPECTIVE RANDOMISED SINGLE 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 |
Kiran Muthu Rajah |
| Designation |
Postgraduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology and Pain Medicine
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai - 600116
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9600001484 |
| Fax |
|
| Email |
kiranmuthurajah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar Kodali v |
| Designation |
Associate Professor of Department of Anaesthesiology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology and Pain Medicine
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai - 600116
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9444230150 |
| Fax |
|
| Email |
vrajesh.kodali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kiran Muthu Rajah |
| Designation |
Postgraduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology and Pain Medicine
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai - 600116
TAMIL NADU
600116
India |
| Phone |
9600001484 |
| Fax |
|
| Email |
kiranmuthurajah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Kiran Muthu Rajah |
| Address |
Department of Anaesthesiology and Pain Medicine,
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai -600116 |
| 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 |
| DrKiran Muthu Rajah |
Sri Ramachandra Institute of Higher Education and Research |
Department of Anaesthesiology and Pain Medicine,
Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116
Kancheepuram
TAMIL NADU |
9600001484
kiranmuthurajah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Quadratus Lumborum plane block |
Quadratus Lumborum Plane block given using 0.4ml/kg 0.125% Bupivacaine +0.5mcg/kg Dexmedetomidine on either side |
| Comparator Agent |
Transversus Abdominis Plane block |
Transversus abdominal plane block given using 0.4ml/kg 0.125% Bupivacaine +0.5mcg/kg Dexmedetomidine on either side |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant Patients ASA II
2. Normal Singleton Pregnancy – Gestational Age ≥ 37weeks
3. Elective Caesarean Section under Subarachnoid block |
|
| ExclusionCriteria |
| Details |
1. Patient Refusal
2. Emergency Lower segment Caesarean Section
3. Coagulation or Bleeding disorders
4. Anatomical abnormalities at block site
5. Allergy to study drug
6. Localized infection at block site
7. Inability to comprehend or participate in the pain scoring |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total number of rescue analgesics used for 24 hours. |
0 minute, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours from the
time of administration of the block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intensity of postoperative pain recorded through Visual Analogue Score |
0 minute, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours from the
time of administration of the block |
| Time to initial onset of pain (VAS 4) and time to first rescue analgesia. |
0 minute, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours from the
time of administration of the block |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
Final Enrollment numbers achieved (Total)= "94"
Final Enrollment numbers achieved (India)="94" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2021 |
| Date of Study Completion (India) |
20/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - kiranmuthurajah@gmail.com
- For how long will this data be available start date provided 05-01-2022 and end date provided 05-07-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
After obtaining Informed consent, patient who fit into inclusion criteria will be enrolled into the study. All patient’s assessment will be done on previous day and nil per oral orders will be given as per department protocol.
Baseline Blood Pressure and heart rate will be recorded before shifting to operating room. After shifting to operating room electrocardiography, noninvasive blood pressure, and oxygen saturation will be connected. An 18G iv line would be secured, following which patients will receive Spinal anaesthesia with 0.5% heavy bupivacaine using 27G Pencan Needle. Intraoperatively heart rate, non-invasive blood pressure, Spo2 will be monitored every 10 to 15 minutes.
Patient will be randomized to one of the groups using computer generated random number. Group A - Patients undergoing Transversus Abdominis Plane Block Group B – Patients undergoing Quadratus Lumborum Block
The allocated group to which the patient belongs would be informed to the anaesthesiologist performing the block prior to shifting the patient inside the Operating room. At the end of the conduct of Caesarean section the allocated block would be performed by the anaesthesiologist
Both groups will receive 0.4ml/kg 0.125% Bupivacaine +0.5mcg/kg Dexmedetomidine on either side using Linear probe of bedside USG machine (Sonosite R ultrasound system, Sonosite INC,) After administering the block, the patient would be shifted to Post Anaesthetic Care Unit and later to the ward and observed by staff nurses for who are blinded regarding the type of block given to the patient for 24 hours.
When VAS >4, the rescue analgesia (Tramadol 50mg IV) will be given and time noted by the Staff nurses
PARAMETERS OBSERVED:
Pain levels assessed using Visual Analogue Scale (VAS), Heart rate, Blood Pressure (SBP/DBP) and SpO2 are noted at 0 minute, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours from the time of administration of the block by the staff nurses in the PACU and ward.
Time to first rescue analgesic (Tramadol 50mg IV) from the time of administration of block.
Patient will continue to be observed in PACU and WARD for total rescue analgesia up to 24 hours from the time of administration of the block |