| CTRI Number |
CTRI/2017/12/010987 [Registered on: 27/12/2017] Trial Registered Prospectively |
| Last Modified On: |
05/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of Pain relief after Ultrasound Guided Quadratus Lumborum Block and Transversus Abdominis Plane Block in of Cesarean Section |
|
Scientific Title of Study
|
Comparison of Ultrasound Guided Quadratus Lumborum Block with Ultrasound Guided Transversus Abdominis Plane Block for Postoperative Analgesia after Lower segment cesarean Section Under Spinal Anaesthesia: A Prospective Randomized 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 |
Dr Ashok Jadon |
| Designation |
Chief Consultant Anaesthesia |
| Affiliation |
Tata Motors Hospital, Jamshedpur |
| Address |
Department of Anaesthesia, 1st Floor, OT Complex, Tata Motors Hospital, Telco Colony, Kharangajhar, Jmashedpur
Department of Anaesthesia, 1st Floor, OT Complex, Tata Motors Hospital, Telco Colony, Kharangajhar, Jmashedpur
Purbi Singhbhum
JHARKHAND
831005
India |
| Phone |
8210626810 |
| Fax |
06572286318 |
| Email |
ashok.jadon@tatamotors.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Jadon |
| Designation |
Guide |
| Affiliation |
Tata Motors Hospital, Jamshedpur |
| Address |
Department of Anaesthesia, 1st Floor, OT Complex, Tata Motors Hospital, Telco Colony, Kharangajhar, Jmashedpur
Department of Anaesthesia, 1st Floor, OT Complex, Tata Motors Hospital, Telco Colony, Kharangajhar, Jmashedpur
Purbi Singhbhum
JHARKHAND
831005
India |
| Phone |
8210626810 |
| Fax |
06572286318 |
| Email |
ashok.jadon@tatamotors.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Jadon |
| Designation |
Chief Consultant Anaesthesia |
| Affiliation |
Tata Motors Hospital, Jamshedpur |
| Address |
Department of Anaesthesia, 1st Floor, OT Complex, Tata Motors Hospital, Telco Colony, Kharangajhar, Jmashedpur
Department of Anaesthesia, 1st Floor, OT Complex, Tata Motors Hospital, Telco Colony, Kharangajhar, Jmashedpur
Purbi Singhbhum
JHARKHAND
831005
India |
| Phone |
8210626810 |
| Fax |
06572286318 |
| Email |
ashok.jadon@tatamotors.com |
|
|
Source of Monetary or Material Support
|
| Tata Motors Hospital, Jamshedpur |
|
|
Primary Sponsor
|
| Name |
Dr Ashok Jadon |
| Address |
Duplex-63, Vijaya Heritage phase-6, kadma, Jamshedpur |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Tata Motors Hospital Jamshedpur |
Telco Colony, Kharangajhar, Jamshedpur-831004 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashok Jadon |
Tata Motors Hospital |
Anaesthesia department, 1st floor, OT Complex,Tata Motors Hospital, Jamshedpur
Purbi Singhbhum
JHARKHAND |
8210626810
06572286318
ashok.jadon@tatamotors.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Motors Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, Patients of lower segment caesarean section under spinal anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Quadratus Lumborum Block (QL-3) |
After Caesarean section surgery, Transmuscular Quadratus lumborum Block (QL-3) with 20ml 0.375% Ropivacaine on each side will be given with the help of Ultrasound using Low frequency (2-5 Mhz)probe in lateral position. |
| Intervention |
Ultrasound guided Transversus Abdominis Plane Block |
After Caesarean section surgery, Transversus Abdominis Plane Block with 20ml 0.375% Ropivacaine on each side will be given with the help of Ultrasound using High frequency (6-13Mhz) probe. |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing lower segment casearean section under spinal anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Refusal to consent, Uncontrolled hypertension and diabetes mellitus, coagulopathy, allergic to local anaesthetic |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Time to first analgesic request.
2.Number of Tramadol injections |
1.Hours after block.
2. 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pain, Nausea, sedation scores.
2. Complication of Blocks
3. Patients satisfaction |
1. During 24 hrs.
2. Within 24 hrs
3. After 24 hrs. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2018 |
| Date of Study Completion (India) |
01/02/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
02/02/2019 |
|
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)?
|
Brief Summary
Modification(s)
|
Transversus Abdominis Plane (TAP) block is already established technique to provide add-on analgesia in multi-modal analgesic regimen in caesarean section patients. Quadratus lumborum block (QL-3)is a new promising technique which has been used successfully to provide effective postoperative analgesia in many abdominal surgeries. However, information regarding its use in caesarean section surgery is limited. This is a randomized controlled trial which will compare the Trans-muscular Quadratus Lumborum Block (QL-3) with Transversus Abdominis Plane Block (TAP) in terms of duration of analgesia and requirements of rescue analgesics injection Tramadol in patients of lower segment caesarean section done under spinal anaesthesia. Two groups, each group containing 30 patients will receive either TAP or QL-3 block with 20ml 0.375% Ropivacaine each side. Primary and secondary outcomes will be compared by using appropriate statistical tool. |