| CTRI Number |
CTRI/2024/06/068654 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Research study comparing pain relief effectiveness between Erector Spinae plane block and Quadratus Lumborum block in adult elective abdominal hysterectomy surgeries. |
|
Scientific Title of Study
|
Comparision of analgesic efficacy between USG guided Erector Spinae Plane Block and Quadratus Lumborum Block in adult elective abdominal hysterectomy surgeries under Spinal Anaesthesia |
| 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 Pallav Pattnaik |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences, Raebareli |
| Address |
Department of Anaethesia, AIIMS , Munshiganj , Raebareli , U.P
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
9438650310 |
| Fax |
|
| Email |
pallav.pattnaik3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupendra Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, Raebareli |
| Address |
Department of Anaesthesia , AIIMS , Munshiganj , Raebareli , U.P
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
9694744962 |
| Fax |
|
| Email |
abhiraj997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupendra Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, Raebareli |
| Address |
Department of Anaesthesia , AIIMS , Munshiganj , Raebareli , U.P
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
9694744962 |
| Fax |
|
| Email |
abhiraj997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesiology, AIIMS Raebareli, UP |
|
|
Primary Sponsor
|
| Name |
AIIMS Raebareli |
| Address |
AIIMS Raebareli , Munshiganj , Raebareli , U.P , India , 229405 |
| 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 Pallav Pattnaik |
AIIMS Hospital , Raebareli |
Department of Anaesthesia , 2nd floor , AIIMS Hospital , Munshiganj , Raebareli , U.P , 229405
Rae Bareli
UTTAR PRADESH |
9438650310
pallav.pattnaik3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIOETHICS CELL , ALL INDIA INSTITUTE OF MEDICAL SCIENCES , Raebareli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae plane block |
The enrolled patients will be randomly allocated via computer generated random number into 2 gropus. Patents will receive ultrasound guided Erector Spinae Plane block with study drug( 0.5% levobupivacaine 10 ml ) which will be performed by an anaesthesiologist not involved in the assessment of post operative pain based on allotment from sealed envolopes.Post operative pain will be assesed using the Visual analog scale(VAS) on the scale from 0(no pain) to 10( worst possible pain). VAS scores will be noted at every 4 hours interval post block. A VAS score of more than 4 will be considered as significant and will be given intravenous Tramadol 100 mg in 100 ml NS infusion and will be considered as rescue analgesia. The time for first rescue analgesia and the total tramadol consumption in the first 48 hours postoperative will be recorded. |
| Comparator Agent |
Quradratus Lumborum Block |
The enrolled patients will be randomly allocated via computer generated random number into 2 gropus. Patents will receive ultrasound guided Quadratus Lumborum plane block with study drug( 0.5% Levobupivacaine 10 ml )which will be performed by an anaesthesiologist not involved in the assessment of post operative pain based on allotment from sealed envolopes.Post operative pain will be assesed using the Visual analog scale(VAS) on the scale from 0(no pain) to 10( worst possible pain). VAS scores will be noted at every 4 hours interval post block. A VAS score of more than 4 will be considered as significant and will be given intravenous Tramadol 100 mg in 100 ml NS infusion and will be considered as rescue analgesia. The time for first rescue analgesia and the total tramadol consumption in the first 48 hours postoperative will be recorded |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. BMI between 24-30 kg/m2
2. height between 150-170 cm
3. Duration of Surgery-1.5 to 2 hours
4. Patients of ASA 1 and 2
5. patients undergoing Total Abdominal Hysterectomy |
|
| ExclusionCriteria |
| Details |
1.Patient refusal for procedure
2.Patients having Coagulopathy
3.Patients having cerebrovascular disease
4.Patients having systemic infection
5.Inability to understand the study protocol
6.Patients who have Allergy to local anesthetics
7.Psychopathy that may affect patient evaluation
8.Pregnant Patients
9.Infection at site of injection
10.Patients with Liver disease
11.Patients with kidney disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the duration of analgesia between Erector Spinae Plane Block and Quadratus Lumborum block .
2.To compare the total dose of tramadol needed as rescue analgesia in post operative 48 hours in both groups.
|
48 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the hemodynamic parameters between the groups.
2.To compare any side effects between groups.
|
48 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/07/2024 |
| 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="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is a Randomized, double blinded study comparing the analgesic efficacy of USG guided Erector Spinae Plane block and Quadratus Lumborum block in adult elective abdominal hysterectomy surgeries under spinal anaesthesia is being conducted in AIIMS , Raebareli. The primary outcome is to compare the duration of analgesia between Erector Spinae Plane Block and Quadratus Lumborum Block and to compare the total dose of tramadol consumed as rescue analgesia in post operative 48 hours in both groups. |