| CTRI Number |
CTRI/2022/08/044599 [Registered on: 03/08/2022] Trial Registered Prospectively |
| Last Modified On: |
27/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study between transverse abdominis plane block and quadratus lumborum block for pain management in Caesarean Section operation. |
|
Scientific Title of Study
|
A comparative study between transversus abdominis plane block and quadratus lumborum block for analgesia in elective caesarean section. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ananya Devi |
| Designation |
Postgraduate trainee student |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care
Gauhati Medical College and Hospital
Bhangagarh
Kamrup, Assam
Kamrup
ASSAM
781032
India |
| Phone |
9706551974 |
| Fax |
|
| Email |
ananyadevi1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Faiza Ahmed Talukdar |
| Designation |
Head of the Department |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care
Gauhati Medical College and Hospital
Bhangagarh
Kamrup
Kamrup
ASSAM
781032
India |
| Phone |
9864031429 |
| Fax |
|
| Email |
faizaahmedtalukdar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananya Devi |
| Designation |
Post graduate trainee student |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care
Gauhati Medical College and Hospital
Bhangagarh
Kamrup, Assam
Kamrup
ASSAM
781032
India |
| Phone |
9706551974 |
| Fax |
|
| Email |
ananyadevi1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ananya Devi
Post graduate Trainee Student
Department of Anesthesiology and Critical Care,
Gauhati Medical College and Hospital
Bhangagarh , Guwahati
Kamrup Metro
Assam 781032 |
|
|
Primary Sponsor
|
| Name |
Dr Ananya Devi |
| Address |
Department of Anaesthesiology and Critical Care
Gauhati Medical College and Hospital
Bhangagarh
Kamrup, Assam
781032 |
| 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 |
| Dr Ananya Devi |
Gauhati Medical College and Hospital |
Department of Anaesthesiology and Critical Care
Bhangagarh
Kamrup Metro
Assam
Kamrup
ASSAM |
9706551974
ananyadevi1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Gauhati Medical College and 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 |
Quadratus lumborum block to assess post operative analgesia in elective Cesarean section. |
36 patients will be given ultrasound guided bilateral quadratus lumborum block with 0.2ml/kg of 0.2 % Ropivacaine through a 20 G spinal needle before giving spinal anesthesia in elective Caesarean section in the age group of 18-35 years. The duration of post operative analgesia will be assessed at 2nd, 4th, 6th, 12th and 24th hours with Numerical Rating Scale(NRS). Also, the total number of analgesic doses required and severity of post operative pain will be assessed over a period of 24 hours. |
| Intervention |
Transversus abdominis plane block to assess post operative analgesia in elective Cesarean section. |
36 patients will be given ultrasound guided bilateral transversus abdominis plane block with 0.2ml/kg of 0.2 % Ropivacaine through a 20 G spinal needle before giving spinal anesthesia in elective Caesarean section in the age group of 18-35 years. The duration of post operative analgesia will be assessed at 2nd, 4th, 6th, 12th and 24th hours with Numerical Rating Scale(NRS). Also, the total number of analgesic doses required and severity of post operative pain will be assessed over a period of 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA physical status 2
2. Normal singleton pregnancy with a gestational period of minimum 37 weeks
3. Elective caesarean section under spinal anaesthesia
4. Informed and written consent |
|
| ExclusionCriteria |
| Details |
1.Patient not willing to give consent
2.Patient belonging to ASA physical status 3 or more
3.Allergy to study drugs
4.Infection at the site of block
5.Patient with known coagulopathy or patients on anticoagulation therapy
6.Patient with pregnancy induced hypertension
7.Patient with gestational diabetes mellitus
8.Patient with fetal distress
9.Patient with cardiac disease
10.Patient with kidney disease
11.Patient with morbid obesity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of analgesia in each group after administration of block in the post operative period |
Analgesia will be assessed at 2,4,6,12,24 post operative hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the total number of analgesic dose required over a period of 24 hours.
2. To compare the severity of post operative pain assessment via numerical rating scale. |
Analgesia will be assessed at 2,4,6,12,24 post operative hours |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
10/08/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
It will be sent for publication in peer reviewed journal once the trial is over. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Effective
post-operative analgesia after caesarean section (CS) is important because it
facilitates early amelioration, ambulation and expedites breastfeeding. It
prevents various undesirable side effects such as respiratory complications,
venous thromboembolism, and increased hospital stay. Commonly, opioids are used
for post-caesarean pain relief which is associated with respiratory depression,
gastrointestinal side effects, pruritus, itching, urinary retention etc.
Multimodal analgesia techniques have been applied in post operative pain
management, such as NSAIDs ,opioids, regional anaesthesia etc .Amongst
these ,regional anaesthesia is widely practised nowadays and gaining
popularity. Regional anaesthesia can be done by both landmark guided and Ultrasound
guided method .Various truncal blocks are used for analgesia for caesarean
section such as transversus abdominis plane block, rectus sheath block, erector
spinae block ,quadratus lumborum block etc. The transversus
abdominis plane(TAP) block involves injecting local anaesthetic into the plane
between Transversus abdominis and Internal oblique, which block the sensory
nerve supply to the anterior abdominal wall. TAP block is an easy and most
commonly done procedure for post-operative analgesia, as already been
established in many studies. The Quadratus
lumborum (QL) block is a posterior abdominal wall block which permits spread of
local anaesthetic agent around the quadratus lumborum muscle into a triangular
space known as a lumbar interfascial triangle which lies beside the middle
layer of the thoracolumbar fascia. There are not many studies that have been
done regarding QL block. So in our study we will compare quadratus lumborum
block with transversus abdominis block. References: 1. 1. Kerai S, Saxena KN, Taneja B. Post-caesarean
analgesia: What is new? Indian J Anaesth. 2017;61:200–14. 2. 2. Sinha A, Jayaraman L, Punhani D, Chowbey P.
Transversus abdominis plane block for pain relief in patients undergoing in
endoscopic repair of abdominal wall hernia: A comparative, randomised
double-blind prospective study. J Minim Access Surg.
2018;14(3):197-201. 3. 3. Ghisi D, Fanelli A, Vianello F, Gardini M, Mensi G,
La Colla L, Danelli G. Transversus Abdominis Plane Block for Postoperative
Analgesia in Patients Undergoing Total Laparoscopic Hysterectomy: A Randomized,
Controlled, Observer-Blinded Trial. Anesth Analg. 2016 Aug;123(2):488-92. 4. 4. Schuenke MD, Vleeming A, Van Hoof T, Willard FH. A
description of the lumbar interfascial triangle and its relation with the
lateral raphe: Anatomical constituents of load transfer through the lateral
margin of the thoracolumbar fascia. J Anat. 2012;221:568–76. 5. 5. Verma, Kalpana et al. “Comparison of transversus
abdominis plane block and quadratus lumborum block for post-caesarean section
analgesia: A randomised clinical trial.†Indian Journal of
Anaesthesia vol. 2019: 63(10): 820-826.
6. 6. Yousef NK. Quadratus Lumborum Block versus
Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal
Hysterectomy: A Randomized Prospective Controlled Trial. Anesth Essays Res.
2018 Jul-Sep;12(3):742-747. |