| CTRI Number |
CTRI/2025/11/097128 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on pain relief and patient satisfaction after abdominal surgery using two different anesthesia techniques |
|
Scientific Title of Study
|
Analgesic Effect, Patient Satisfaction And Major Adverse Effect Following Postoperative Erector Spinae Plane Block And Local Wound Infiltration After Elective Abdominal Surgery— A Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naveen Kumar Murugan |
| Designation |
Post Graduate Trainee |
| Affiliation |
R G Kar Medical College And Hospital |
| Address |
Deptartment of Anaesthesiology, Pain and Critical Care Medicine, 7th floor, emergency building, R G Kar Medical College And Hospital, Kolkata, West Bengal
Kolkata WEST BENGAL 700004 India |
| Phone |
9500543062 |
| Fax |
|
| Email |
naveenvenkat0020@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Saikat Niyogi |
| Designation |
Professor |
| Affiliation |
R G Kar Medical College And Hospital |
| Address |
Department of Anaesthesiology, Pain and Critical Care Medicine,7th floor, emergency building, R G Kar Medical College And Hospital, Kolkata, West Bengal
Kolkata WEST BENGAL 700004 India |
| Phone |
9831732443 |
| Fax |
|
| Email |
saikatneuro1972@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Saikat Niyogi |
| Designation |
Professor |
| Affiliation |
R G Kar Medical College And Hospital |
| Address |
Department of Anaesthesiology, Pain and Critical Care Medicine, 7th floor, emergency building, R G Kar Medical College And Hospital, Kolkata, West Bengal
Kolkata WEST BENGAL 700004 India |
| Phone |
9831732443 |
| Fax |
|
| Email |
saikatneuro1972@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
R G Kar Medical College And Hospital |
| Address |
1, Khudiram Bose Sarani, Bidhan Sarani, Shyam Bazar, Kolkata, West Bengal 700004 |
| 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 |
| Naveen Kumar Murugan |
R G Kar Medical College And Hospital |
Surgery Operation Theatre and Postoperative Care Unit, Khudiram Bose Sarani, Shyam Bazar Kolkata WEST BENGAL |
9500543062
naveenvenkat0020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, R.G.Kar Medical College |
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 |
Group E |
Erector Spinae Plane Block with inj.bupivacaine 0.25% 20ml after reversal |
| Comparator Agent |
Group L |
Local Wound Infiltration with inj.Bupivacaine 0.25% 20ml after operation before extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients posted for Exploratory Laparotomy surgery
2) ASA grade 1 and 2 patients
3) Patients with BMI less than 30 |
|
| ExclusionCriteria |
| Details |
1) Uncooperative patients
2) Cardiac and neurological diseases
3) Uncontrolled diabetes and hypertension
4) Known allergy to the drug used
5) Epilepsy
6) Any kind of preexisting neuropathy
7) Alcoholism
8) Chronic opioid use (defined as daily use of opioid for more than 3 month) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Timing of first rescue postoperative analgesia;
2) Total doses of rescue analgesic in the first postoperative 24 hrs.
3) Frequency of rescue analgesic given in the first postoperative 24hrs |
postoperative first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Perioperative hemodynamic response (HR, MAP)
2) Comparison of Postoperative analgesia between two groups –[ assessed by VAS at predefined
intervals (0, 1, 2, 3, 4, 5, 6, 10, 14, 18, 22, 24 hours)]
3) patient satisfaction ( by Likert scale) at 24 hr postoperatively
4) incidence of complications. |
postoperative first 24 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)
|
05/01/2026 |
| 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 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 comparative study will be planned to initiate after obtaining approval from Institutional Ethics Committee and informed consent from all patients. Following a detailed pre anesthetic examination, total 72 patients of American society of Anaethesiologists(ASA) I and II, aged 18-60 years, posted for elective abdominal surgery fulfilling the inclusion criteria will be allocated for this study. They will be randomly divided into two equal groups. Group T -36 ESP block with injection bupivacaine 0.25 percent and Group R -36 LAI with injection bupivacaine 0.25 percent. Randomization will be ensured by an informatically generated random sequence run by a person who will not involved in the study. During preoperative visit, all the patients will be explained about the 100 mm visual analog scale (VAS). All the patients will be advised tablet diazepam (5mg) at the night before OT. In preoperative area intravenous ringer lactate solution will be started at 100ml/h and a standard anaesthetic protocol will be followed for all patients. All the standard ASA monitor like Electrocardiogram(ECG), SPO2, pulse oximetry, capnometer, blood pressure monitor and temperature monitor will be attached with patient for continuous monitoring. Baseline values are noted before anaesthesia for all patients and will receive general anaesthesia according to a standard protocol with ASA monitoring. After securing IV line with an 18G cannula. Intravenous(IV) induction will be done with Inj. Fentanyl (2 mcg/kg), Inj. Loxicard (1 mg/kg), Inj. Propofol (2 mg/kg) and Inj.Atracurium (1mg/kg) will be administered for endotracheal intubation (ET). Patients will be maintained with N2O and O2 mixture in 1:1 ratio, inhalational isoflurane 0.5-1% to maintain bispectral index <50 and Inj. Atracurium (0.5 mg/kg) will be administered if TOF count more than 0.4. Intraoperative pulse rate (PR), Blood pressure (BP), oxygen saturation (SPO2) will be noted at 30 min interval till the end of operation for the surgery of duration 2 - 2½ hrs. Intra operatively whenever there will be increase in BP and Heart Rate (HR) by more than 20% from pre-operative baseline value, will be treated with intravenously IV Fentanyl bolus 1 mcg/kg . Before reversal of neuromuscular block, the group LAI group patients will be infiltrated with 20 ml of 0.5 % bupivacaine by subcutaneous infiltration ( maximum 0.4 ml/kg) by the operating surgeon. On the other hand, ESPB group will receive the block in lateral position at the end of operation before reversal. Ultrasound guided linear or convex probe will be used depending on the depth of transverse process. A 22G x 80 mm needle used for ESPN block. For parasagittal view probe will be placed longitudinally beside the spine. The needle will be directed towards medial transverse process of mid level vertebra. When the needle comes to the contact with the transverse process, 20 ml 0.25% bupivacaine will be injected on either side of target vertebra. After this, all the patients will be reversed with IV Myopyrolate 5 ml (0.5 mg Glycopyrrolate and 2.5 mg neostigmine). After extubation, patient will be shifted to recovery room and when the patient will be stabilized (alderate score more than 9), all the patient transferred to Surgical ICU for immediate 24hrs after operation. Patient, investigator and statistician all will be remain blinded regarding the type of block. Postoperatively analgesia will be assessed with Visual analog scale (VAS) at 0, 1, 2, 3, 4, 5, 6, 10, 14, 18, 22 and 24 h. Intravenous paracetamol (15mg/ kg) 8 hourly will be administered as baseline analgesic. IV tramadol 2mg/kg will be administered if VAS score more than 4. The timing of first analgesic requirement will be considered as duration of analgesia. Postoperative hemodynamics (PR, BP) will also be noted at 0, 1, 2, 3, 4, 5, 6, 10, 14, 18, 22 and 24hrs. Duration of analgesia and postoperative total IV tramadol requirement will be considered as primary outcome. Patient satisfaction will be assessed by likert scale at 24 hours after surgery. Postoperative hemodynamics and any adverse effect like nausea, vomiting, sedation will be considered as secondary outcome. |