| CTRI Number |
CTRI/2024/03/063615 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare external oblique intercostal fascial plane block and erector spinae plane block in patients undergoing open abdominal surgeries by assessing pain after surgery |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of ultrasound guided
External oblique Intercostal fascial Plane (EOI) Block versus Erector Spinae Plane
(ESP) Block in adult patients undergoing open upper abdominal surgeries: A
randomized controlled trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Angad Maurya |
| Designation |
Anaesthesia Academic Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Anesthesiology,Room no. 307, Hostel - 1,Aiims patna, Phulwari Sharif ,Patna 801507, Bihar, India
Patna BIHAR 801507 India |
| Phone |
7739099932 |
| Fax |
|
| Email |
angadmaurya9@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Chandni Sinha |
| Designation |
Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Anesthesiology AIIMS Patna
Patna BIHAR 801507 India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Chandni Sinha |
| Designation |
Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Anesthesiology aiims patna
Patna BIHAR 801507 India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Patna,Phulwari Sharif,Patna,Bihar,801507, India. |
|
|
Primary Sponsor
|
| Name |
Aiims Patna |
| Address |
Department of Anesthesiology Aiims Patna |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Angad Maurya |
All India Institute Of Medical Sciences |
Department of Anaesthesia, 5th floor, ot complex, ipd bulding, AIIMS Patna Patna BIHAR |
7739099932
angadmaurya9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aiims Patna |
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 |
Erector Spinae plane block |
25 ml 0.2 % ropivacaine in erector spinae plane alone
single shot prior to surgery |
| Intervention |
External oblique intercostal plane block and erector spinae plane block |
25 ml of 0.2 % ropivacaine in each external oblique intercostal plane and erector spinae plane single shot prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients 18 -75 years,
American Society of Anesthesiologists-physical status (ASA-PS) I–II undergoing open
upper abdominal surgery with Unilateral Subcostal incision
Patients willing to give written informed consent |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare 24-hour postoperative opioid consumption in ESP block group and
EOI block group via numerical rating scale (NRS) |
To assess and compare 24-hour postoperative opioid consumption in ESP block group and
EOI block group via numerical rating scale (NRS) at 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours and 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to first rescue analgesia.
Numerical rating scores of pain (rest and cough) in first 24-hour postoperative period
Total intraoperative opioid consumption
Postoperative opioid consumption
|
From the time of administration of block to first need of use of analgesic administration
30 mins, 2,4,8,12,16,24 hours.
from the time of administration of block to end of surgery
at 4, 8, 12, 16 hours
|
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
17/03/2024 |
| 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 Applicable |
| 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 randomized controlled study to compare analgesic efficacy of external oblique intercostal plane block and erector spinae plane block in adult patients undergoing open upper abdominal surgery using ultrasound machine. Primary objective of this study to assess and compare 24-hour postoperative opioid consumption in External oblique intercostal plane block group and Erector spinae plane block group.
All patients will be recruited one day prior to surgery and a detailed pre anaesthetic assessment will be done. The patients will be instructed to stay nil per oral (NPO) according to standard fasting guidelines prior to surgery. After shifting the patients to operating room standard ASA monitors will be attached and baseline vitals like heart rate (HR), noninvasive blood pressure (NIBP), Electrocardiogram (ECG), oxygen saturation (SpO2), and temperature will be monitored. General anaesthesia (GA) will be given using intravenous Fentanyl 2 μg/kg, Propofol 2 mg/kg and Atracurium 0.5 mg/kg. Paracetamol 15 mg/kg and Dexamethasone 6 mg IV would be administered to all patients. An anesthesiologist with expertise executing blocks who has performed minimum 25 such blocks (who will be blinded to the collected data until the end of the trial) will perform the block procedures. Both blocks will be done under strict aseptic conditions with ultrasound machines equipped with a high-frequency linear probe with a sterile sheath Group A will receive US - guided External oblique intercostal plane block using 25 ml of 0.2% Ropivacaine along with GA. Group B: will receive US-guided Erector Spinae plane block External oblique intercostal plane block using 25 ml of 0.2% Ropivacaine at T7 level along with GA. Time of block performance(TBP) will be observed in each group. The TBP will be accepted as the time from the placement of the US probe on the skin to the administration of the injection and will be recorded by the anesthesia technician. Anesthesia will be maintained with sevoflurane, oxygen and air with a target MAC of 1. Skin incision will be allowed 15 minutes after the injection of study solutions in both the groups. Intraoperative any increase in HR/MAP more than 20% intraoperatively will be treated with additional fentanyl doses of 0.5 mcg/kg. Total intraoperative fentanyl consumption will be noted in both groups. Intraoperatively MAP and HR will be recorded at 5, 30, 60, and 90 minutes afterskin incision and at the end of surgery. No local anesthetic will be used by the surgeon for infiltration in either of the groups. At the end of surgery, all the patients will receive Injection Ondansetron 0.1mg/kg and reversal agent (Injection neostigmine 0.05mg/kg and injection glycopyrrolate 0.01mg/kg). The patient will be shifted to the post anesthesia care unit (PACU) with oxygen supplementation by mask as per requirements. Postoperatively all patients will receive 15 mg/kg IV paracetamol every 6 hours. Pain perception will be measured in the PACU at rest by using NRS (0–10) at 30 minutes, 2,4,8,12,16 and 24 hour All patients enrolled in the study will be given a patient controlled analgesia (PCA) pump programmed for a demand-only mode with no basal rate; the program will deliver a bolus of fentanyl 25 micg with a maximum of 6 doses in an hour. This study include adult patients age between 18- 75 years. The calculated sample size is 50. Expected duration of surgery 1.5 years
|