CTRI Number |
CTRI/2023/01/049255 [Registered on: 27/01/2023] Trial Registered Prospectively |
Last Modified On: |
25/01/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A randomised controlled study to assess the effectiveness of ultrasound guided bilateral erector spinae block (a type of inter-fascial plane block) for post-operative pain relief in laparoscopic (keyhole) abdominal surgeries. |
Scientific Title of Study
|
A randomised controlled study to assess the efficacy of ultrasound guided bilateral erector spinae block for post-operative analgesia in laparoscopic abdominal surgeries. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Shariaa Ghufran |
Designation |
Junior Resident |
Affiliation |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh. |
Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh.
Aligarh UTTAR PRADESH 202002 India |
Phone |
8272869687 |
Fax |
|
Email |
shariaa.amu@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Qazi Ehsan Ali |
Designation |
Professor |
Affiliation |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh. |
Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh.
Aligarh UTTAR PRADESH 202002 India |
Phone |
7417701769 |
Fax |
|
Email |
qaziehsanali@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Shariaa Ghufran |
Designation |
Junior Resident |
Affiliation |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh. |
Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh.
Aligarh UTTAR PRADESH 202002 India |
Phone |
08272869687 |
Fax |
|
Email |
shariaa.amu@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh. |
|
Primary Sponsor
|
Name |
Department of Anaesthesiology and Critical Care, JNMCH, AMU, Aligarh. |
Address |
Department of Anaesthesiology and Critical Care, JNMCH, AMU, Aligarh. |
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 |
Shariaa Ghufran |
Jawaharlal Nehru Medicine College and Hospital, AMU, Aligarh. |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh. Aligarh UTTAR PRADESH |
8272869687
shariaa.amu@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 3||Administration, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Erector spinae plane block |
Bilateral Ultrasound guided Erector Spinae Plane Block will be given in the patients undergoing laparoscopic abdominal surgeries under General anaesthesia. It will be given after the completion of the surgery and before the extubation of the patient. 15 ml of 0.25% Bupivacaine would be used in each side |
Comparator Agent |
No erector spinae plane block (Control Group) |
In control group, only conventional intravenous analgesics will be administered and no fascial plane block will be given. |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Patients undergoing elective laparoscopic abdominal surgery under general anaesthesia in JN Medical College and Hospital in time periods between 2022-24.
ASA grade I and II.
BMI between 18 to 25kg/sq.m |
|
ExclusionCriteria |
Details |
Patient’s refusal.
History of allergy to analgesics.
Allergic to local anaesthetic
Skin infection at puncture site.
Deranged coagulation profile.
Pulmonary, renal, cardiac or any other systemic disorder.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
Duration of post-operative analgesia. |
It will be assessed as time from the time of extubation to the time when patient request for the first dose of analgesic. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Total analgesic required in 24hr period |
Rescue analgesic when patient complains of pain with NRS score more than 3 (with minimum interval of 6 hours between two doses). Total doses of analgesic required by patient in 24 hours post-operatively will be calculated in morphine milligram equivalent dosage. |
NRS score for assessing post operative pain |
First recording will be recorded in recovery room when patient will be well oriented to time place and person. It will be taken as 0 hour. Then it will be taken at 2nd hour, 6th hour and 24th hour. Further, mean of the four values will be taken. |
Complications- allergic reactions, nausea/vomiting, unsuccessful block, accidental intra-vascular injection & it’s consequences and pneumothorax. |
Postoperatively, in first 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
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
01/02/2023 |
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="2" Months="0" 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
|
A randomised controlled study to assess the efficacy of ultrasound guided bilateral erector spinae block for post-operative analgesia in laparoscopic abdominal surgeries: During abdominal surgery pain is multifactorial. Insufficient post-operative pain management hampers the achievement of good recovery after surgery and the risk of postoperative complications like delayed mobilization, ileus, nausea, chronic pain, with which patient’s satisfaction can seriously be affected with prolonged hospital stay that increases the financial burden both at the individual and societal level. Thus, adequate post-operative pain management in patients undergoing abdominal surgery is though challenging but rewarding task. Some of the efficacious analgesic options are intravenous drugs mainly the opioids, epidural block, fascial plane blocks like Transversus abdominis plane (TAP) block and Erector spine plane (ESP) block Opioids are successful in the treatment of visceral pain but not so effective for somatic pain and are related to side effects such as constipation, nausea and vomiting, pruritus, and life threatening respiratory depression. Frequent concerns with epidural block are hypo-coagulability and post-operative hypotension. One of the recent techniques include facial plane blocks like Erector spine plane (ESP) and Transversus Abdominis Plane (TAP) block. With ESP block, both visceral as well as somatic analgesia are provided, acute as well as chronic pain are relieved by it and can be utilised for analgesia at cervical, thoracic & m abdominal levels with minimal side effects. ESPB has shown significant analgesic effect with lesser pain scores and lower opioid consumption during various abdominal surgeries in the post-operative period. In our study we will compare the efficacy of Ultrasound guided bilateral erector spine block in post-operative analgesia in abdominal surgeries with another group in which block won’t be given. |