| CTRI Number |
CTRI/2024/02/062925 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the duration of post operative pain relief after administration of ultrasound-guided Quadratus Lumborum block and Transversus Abdominis Plane block in patients undergoing Cesarean Section. |
|
Scientific Title of Study
|
Ultrasound-Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for post operative analgesia in patients undergoing Lower Segment Cesarean Section: A randomized comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonali Samant |
| Designation |
Post Graduate Student |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences, Dr. Ram Manohar Lohia Hospital |
| Address |
Department of Anaesthesiology,
3rd floor, PGIMER building,
Atal Bihari Vajpayee Institute of Medical Sciences, Dr. Ram Manohar Lohia Hospital, New Delhi.
New Delhi
DELHI
110001
India |
| Phone |
7042057756 |
| Fax |
|
| Email |
sonalisamant16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Gupta |
| Designation |
Associate Professor |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences, Dr Ram Manohar Lohia Hospital, New Delhi |
| Address |
Department of Anaesthesiology,
3rd floor, PGIMER building,
Atal Bihari Vajpayee Institute of Medical Sciences, Dr Ram Manohar Lohia Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9899567234 |
| Fax |
|
| Email |
nehaguptadeuri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Samant |
| Designation |
Post Graduate Student |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences, Dr Ram Manohar Lohia Hospital, New Delhi |
| Address |
Department of Anaesthesiology,
3rd floor, PGIMER Building,
Atal Bihari Vajpayee Institute of Medical Sciences, Dr Ram Manohar Lohia Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
7042057756 |
| Fax |
|
| Email |
sonalisamant16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Atal Bihari Vajpayee Institute of Medical Sciences, Dr Ram Manohar Lohia Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Atal Bihari Vajpayee Institute of Medical Sciences, Dr Ram Manohar Lohia Hospital, New Delhi-110001 |
| 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 |
| Dr Sonali Samant |
Atal Bihari Vajpayee Institute of Medical Sciences, Dr Ram Manohar Lohia Hospital, New Delhi |
Department of Anaesthesiology,
PGIMER building,
ABVIMS, Dr RML hospital,
Baba Kharak Singh Marg,
Near Gurudwara Bangla Sahib,
Connaught Place, New Delhi, Delhi 110001
New Delhi
DELHI |
7042057756
sonalisamant16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Atal Bihari Vajpayee Institute of Medical Sciences, Dr Ram Manohar Lohia Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Quadratus Lumborum block |
Ultrasound-guided Quadratus Lumborum Block with 20 ml of 0.25% bupivacaine administered on each side (maximum dose- 2 mg/kg).The nerve block will be administered at the end of the surgery in the operation theatre and patient will be monitored for 24 hrs. |
| Intervention |
Transversus Abdominis Plane block |
Ultrasound-guided Transversus Abdominis Plane Block with 20 ml of 0.25% bupivacaine on each side (maximum dose- 2 mg/kg). The nerve block will be administered at the end of the surgery in the operation theatre and patient will be monitored for 24 hrs. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients posted for Lower Segment Cesarean Section under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1. ASA physical status III and IV
2. Known allergy to local anaesthetic drugs
3. Coagulation disorders
4. Local infection at the site of block |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia (time at which first rescue analgesic required) |
time at which first rescue analgesic required, that is, Numeric Rating Score more than 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for administration of block (time taken from insertion of needle to administration of drug) |
time taken from insertion of needle to administration of drug |
| Adverse effects related to the block- Local hematoma or infection, lower limb weakness, hemodynamic variations . |
24 hrs |
| Total dose of rescue analgesic required in first 24hrs postoperatively |
24 hrs |
| Maternal satisfaction |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
29/02/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ultrasound-guided Quadratus Lumborum block and Transversus Abdominis Plane block are well established modes of administering postoperative analgesia in various abdominal surgeries. However, there are very few studies comparing the efficacy of these two blocks in Lower Segment Cesarean Section surgeries. In this study, the efficacy of these two blocks will be measured in terms of the duration of postoperative analgesia, that is, the time at which first rescue analgesic would be required, in patients undergoing Lower Segment Cesarean Section under spinal anaesthesia. The blocks will be performed at the end of the surgery with 20 ml of 0.25% Bupivacaine on each side (maximum dose not exceeding 2 mg/kg) . The outcome measures will be evaluated using appropriate statistical tools.
|