| CTRI Number |
CTRI/2024/07/070256 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between spinal anesthesia versus spinal anesthesia with erector muscle plane block for postoperative pain relief in lower abdominal surgeries patient |
|
Scientific Title of Study
|
A comparative study on Spinal anesthesia alone versus spinal
anesthesia along with Ultra sound guided bilateral erector spinae plane block for
post operative analgesia in lower abdominal surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alatfuddin Ahmed |
| Designation |
Associate professor |
| Affiliation |
Tezpur medical college and hospital, Assam |
| Address |
Department of Anaesthesiology, Tezpur Medical College and Hospital, Tumuki, Bihaguri
Sonitpur
ASSAM
784010
India |
| Phone |
9435032380 |
| Fax |
|
| Email |
draltafahmeddbr@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shuvodeep Das |
| Designation |
Post Graduate Trainee |
| Affiliation |
Tezpur Medical College and Hospital |
| Address |
Department of Anaesthesiology, Room no 3,Tezpur Medical College and Hospital, Tumuki, Bihaguri
Sonitpur
ASSAM
784010
India |
| Phone |
9432368145 |
| Fax |
|
| Email |
deepdas55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shuvodeep Das |
| Designation |
Post Graduate Trainee |
| Affiliation |
Tezpur Medical College and Hospital |
| Address |
Department of Anaesthesiology,Room no 3, Tezpur Medical College and Hospital, Tumuki, Bihaguri
Sonitpur
ASSAM
784010
India |
| Phone |
9432368145 |
| Fax |
|
| Email |
deepdas55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tezpur medical college and hospital,Tumuki, Bihaguri, District Sonitpur, pin 784010 Assam |
|
|
Primary Sponsor
|
| Name |
Shuvodeep Das |
| Address |
Department of Anaesthesiology,
Tezpur Medical College and Hospital, Tumuki, Bihaguri, District - Sonitpur, Assam
Pin 784010 |
| 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 |
| DrShuvodeep Das |
Tezpur medical college and hospital |
Department of anesthesiology, Room 3, Bihaguri, Tumuki, District Sonitpur, Pin 784010
Sonitpur
ASSAM |
9432368145
deepdas55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee Tezpur medical college and hospital |
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 |
| Comparator Agent |
Intrathecal bupivacaine 15mg versus intrathecal bupivacaine along bilateral erector spinae plane block with levobupivacaine 50mg |
Comparison between two groups. One with spinal anesthesia only. Other one with spinal anesthesia along with erector spinae plane block |
| Intervention |
Spinal Anaesthesia versus spinal anesthesia and bilateral erector spinae plane block |
Intrathecal bupivacaine 15mg vs Intrathecal bupivacaine15mg and ultrasound guided levobupivacaine 50mg injection in erector spinae muscle plane |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 70 years
Body weight 50kg to 75 kg BMI more than 18.5 to less than 25
American Society of Anaesthesiology Physical Status I and II
Scheduled for elective lower abdominal surgeries under spinal anaesthesia
Lower abdominal surgeries which will be done making incision such as infraumbilical midline or paramedian incision, pfannenstiel incision, bilateral oblique incision over inguinal region
|
|
| ExclusionCriteria |
| Details |
Patient refusal to participate
Patients requiring emergency surgery
Patients having remarkable history of cardiovascular, metabolic or psychological disorder
Pregnant patient or lactating mother
Patient having known coagulopathy or patient on anticoagulation therapy
Patient having infection at site of injection
|
|
|
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 |
| Analgesia will be assessed post operatively using Visual Analogue Scale |
30 mins
1 hour
3 hours
6 hours
12 hours
18 hours
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters i.e. Pulse Rate, Systolic BP, Diastolic BP, Mean Arterial Pressure |
30 mins
1 hour
3 hours
6 hours
12 hours
18 hours
24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
27/07/2024 |
| 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="0"
Days="0" |
|
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
|
A prospective, randomized parallel arm trial will be undertaken as a comparative study on Spinal anesthesia alone versus spinal anesthesia along with Ultra sound guided bilateral erector spinae plane block for post operative analgesia in lower abdominal surgeries. All patients will receive spinal anaesthesia, but the test group will receive additional bilateral erector spinae plane block in lateral position under ultrasound guidance immediately after operation. To achieve adequate ESP block, 20ml of levobupivacaine (0.25%) will be injected in each side. The primary outcome is to assess analgesia post operatively using Visual Analogue Scale (0 - no pain and 10 - worst pain) at 30 mins, 1 hour, 3 hours, 6 hours, 12 hours, 18 hours and 24 hours. The secondary outcomes to be studied are hemodynamic parameters i.e. Pulse
Rate, Systolic BP, Diastolic BP, Mean Arterial Pressure at similar time point. The study site is Tezpur Medical College and Hospital, Assam and study duration is 1 year. The sample size assuming level of significance alpha 0.05 and power of study 0.8, is calculated to be 70. |