| CTRI Number |
CTRI/2021/01/030742 [Registered on: 25/01/2021] Trial Registered Prospectively |
| Last Modified On: |
22/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of two techniques-ultrasound guided quadratus lumborum block and intrathecal fentanyl for post operative analgesia in patients undergoing caeserean section |
|
Scientific Title of Study
|
Comparison of ultrasound-guided bilateral quadratus lumborum block versus intrathecal fentanyl for postoperative analgesia after caesarean section: a randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhasish Patnaik |
| Designation |
Anaesthesiologist |
| Affiliation |
Air Force Hospital |
| Address |
Officer in charge OT,
Department of Anaesthesiology and critical care,
Air force Hospital,Rowriah,Jorhat
05 Air Force Hospital
Jorhat,Assam
Jorhat
ASSAM
785005
India |
| Phone |
8826347370 |
| Fax |
|
| Email |
subhasishpatnaik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhasish Patnaik |
| Designation |
Anaesthesiologist |
| Affiliation |
Air Force Hospital |
| Address |
Officer in charge OT,
Departement of Anaesthesiology & critical care ,Air force Hospital,Rowriah,Jorhat
05 Air Force Hospital
Jorhat,Assam
Jorhat
ASSAM
785005
India |
| Phone |
8826347370 |
| Fax |
|
| Email |
subhasishpatnaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhasish Patnaik |
| Designation |
Anaesthesiologist |
| Affiliation |
Air Force Hospital |
| Address |
Officer in charge OT,
Department of Anaesthesiology and critical care,Air force Hospital,Rowriah,Jorhat
05 Air Force Hospital
Jorhat,Assam
Jorhat
ASSAM
785005
India |
| Phone |
8826347370 |
| Fax |
|
| Email |
subhasishpatnaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| 05 Air Force Hospital,Jorhat,Assam |
|
|
Primary Sponsor
|
| Name |
Air Officer Commanding |
| Address |
05 Air Force Hospital
Jorhat,Assam |
| 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 |
| subhasish patnaik |
05 Air Force Hospital,Jorhat |
Operation theatre,Old Family ward,Post operative Room,
Jorhat
ASSAM |
8826347370
subhasishpatnaik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 5 Air Force Hospital |
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 |
Intrathecal Fentanyl
Ultrasound guided Quadratus Lumborum Block |
One Group- recieve intrathecal fentanyl
Other group will receive ultrasound guided Qudratus lumborum block |
| Comparator Agent |
Intrathecal Fentanyl |
25 microgram of fentanyl intrathecally for post operative analgesia |
| Intervention |
Ultrasound Guided Quadratus Lumborum Block |
Ultrasound guided (linear probe,in plane approach ) bilateral quadratus lumborum block with local anaesthestics agent- 15 ml of 0.375% Ropivacine each side |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ALL American society of Anaesthesiologist Physical Status-II patients undergoing caeserean section under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1)Patients history of allergy to any of the study drugs,
2)Body mass index (BMI) ≥ 35 kg/m2
3)History of Opioid abuse
4)Gestational Diabetes
5)Heart failure
• Fungal/viral systemic/local infection
• Hypertensive disorders
• Psychiatric illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time to first rescue analgesia and pain score at 4,6 ,12 ,24 hours in both the groups |
04,06,12,24 hours after the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To note the time for first ambulation ,quality of recovery and any adverse effects like nausea, vomiting, respiratory depression |
24 hours |
|
|
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)
|
26/01/2021 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background- Caeserean section is the most performed surgeries in obstetrics and gynaecology.Adequate analgesia after surgery is much required for the patients for early ambulation and also to feed the newborn.Opioids have been the cornerstone for analgesia .However they are associated with adverse effects like nausea,vomiting,pruritus.Truncal blcoks like transversus abdominis (TAP) block has already been studied as a alternative for opiods. Recent studies have concluded that TAP block does not provide adequate analgesia as it relives the somatic pain only. Quadratus lumborum block is a extension of TAP block.It affects both the soamtic and visceral pain and provide adequate analgesia.The study is aimed to compare the effect of ultrasound guided quadratus lumborum block in post analgesia of patients undergoing caeserean section.Any positive outcome will result in providing opiod free analgesia to post caeserean patients |