CTRI Number |
CTRI/2021/07/034629 [Registered on: 06/07/2021] Trial Registered Prospectively |
Last Modified On: |
07/11/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
COMPARISON OF ULTRASOUND GUIDED ERECTOR SPINAE PLANE BLOCK (PAIN RELIEF TECHNIQUE) PERFORMED WITH DIFFERENT CONCENTRATIONS OF MEDICINE (BUPIVACAINE) FOR POST SURGERY PAIN SEVERITY, SURGICAL STRESS AND SATISFACTION IN PATIENTS UNDERGOING GALL BLADDER REMOVAL (LAPAROSCOPIC CHOLECYSTECTOMY) SURGERY. |
Scientific Title of Study
|
COMPARISON OF THE EFFICACY OF ULTRASOUND–GUIDED ERECTOR SPINAE PLANE BLOCK PERFORMED WITH DIFFERENT CONCENTRATIONS OF BUPIVACAINE FOR POSTOPERATIVE ANALGESIA, REDUCTION IN PERIOPERATIVE STRESS MARKERS AND PATIENT SATISFACTION IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS : A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, CONTROLLED CLINICAL TRIAL |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr ALI SALODA |
Designation |
FIRST YEAR PG RESIDENT ANAESTHESIA |
Affiliation |
HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
Address |
OPERATION THEATRE, 8th FLOOR, ANAESTHESIA DEPARTMENT,
HAMDARD INSTITUTE OF MEDICAL
SCIENCES AND RESEARCH, HAMDARD NAGAR DELHI 110062 SOUTH DELHI OPERATION THEATRE, 8th FLOOR, ANAESTHESIA DEPARTMENT,
HAMDARD INSTITUTE OF MEDICAL
SCIENCES AND RESEARCH, HAMDARD NAGAR DELHI 110062 SOUTH DELHI South DELHI 110062 India |
Phone |
9928297948 |
Fax |
|
Email |
ali.saloda@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Kharat Mohd Batt |
Designation |
Professor and Head Of Department, Department of Anaesthesia |
Affiliation |
HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
Address |
OPERATION THEATRE, 8th FLOOR, ANAESTHESIA DEPARTMENT,
HAMDARD INSTITUTE OF MEDICAL
SCIENCES AND RESEARCH, HAMDARD NAGAR DELHI 110062 SOUTH DELHI OPERATION THEATRE, 8th FLOOR, ANAESTHESIA DEPARTMENT,
HAMDARD INSTITUTE OF MEDICAL
SCIENCES AND RESEARCH, HAMDARD NAGAR DELHI 110062 SOUTH DELHI South DELHI 110062 India |
Phone |
9622457554 |
Fax |
|
Email |
hod.anaesthesia@himsr.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr ALI SALODA |
Designation |
FIRST YEAR PG RESIDENT ANAESTHESIA |
Affiliation |
HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
Address |
OPERATION THEATRE, 8th FLOOR, ANAESTHESIA DEPARTMENT,
HAMDARD INSTITUTE OF MEDICAL
SCIENCES AND RESEARCH, HAMDARD NAGAR DELHI 110062 SOUTH DELHI OPERATION THEATRE, 8th FLOOR, ANAESTHESIA DEPARTMENT,
HAMDARD INSTITUTE OF MEDICAL
SCIENCES AND RESEARCH, HAMDARD NAGAR DELHI 110062 SOUTH DELHI South DELHI 110062 India |
Phone |
9928297948 |
Fax |
|
Email |
ali.saloda@gmail.com |
|
Source of Monetary or Material Support
|
Hamdard Institute of Medical Sciences and Research, Delhi |
|
Primary Sponsor
|
Name |
Dr Ali Saloda |
Address |
Hamdard Institute of Medical Sciences and HAHC Hospital, Hamdard Nagar, New Delhi, 110062 |
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 |
Dr Ali Saloda |
HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, HAMDARD NAGAR, DELHI 110062 |
OPERATION THEATRE, 8th FLOOR, ANAESTHESIA DEPARTMENT, HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH HAMDARD NAGAR DELHI 110062 South DELHI |
9928297948
ali.saloda@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH AND ASSOCIATED HAH CENTENARY HOSPITAL(IEC-HIMSR) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Group 1 Control Group |
Control Group - No block |
Intervention |
Group 2 - USG - ESPB with 0.25% bupivacaine |
USG Guided Erector spinae plane block given at the level of T7, with 20 ml of 0.25% bupivacaine bilaterally. |
Intervention |
Group 3 - USG - ESPB with 0.375% bupivacaine |
USG Guided Erector spinae block given at the level of T7, with 20ml of 0.375% bupivacaine bilaterally. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
All patients aged 18-65yrs, posted for elective laparoscopic cholecystectomy, with American society of Anaesthesiologist (ASA) physical status I-II shall be included in the study. |
|
ExclusionCriteria |
Details |
1. Patient refusal.
2. Patients with known allergy to local anaesthetics.
3. Patients with presence of bleeding disorders.
4. Patients with infection at injection sites.
5. Patients with prior addiction or analgesics abuse (opioid and nonsteroidal anti-inflammatory drug medications).
6. Patients with BMI <18.5kg/m2 and >34.9kg/m2.
7. Patients with weight under 50kgs.
8. Patients with liver or renal insufficiency.
9. Patients with history of psychiatric or neurological disease, deafness.
10. Patients in whom the total surgical duration exceeds 2 hours (after incision) or surgery is converted to open cholecystectomy.
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the reduction in Numerical Rating Scale (NRS) score at 30 minutes after extubation between the control group, group receiving ESPB with bupivacaine 0.25% and the group receiving ESPB with bupivacaine 0.375% respectively. |
30 minutes after extubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To compare total intraoperative fentanyl requirement in the 3 groups.
2. To compare total analgesic consumption postoperatively in 24 hours between the 3 groups.
3. To compare change in pre and post-operative surgical stress markers (NLR- neutrophil-lymphocyte ratio, PLR- platelet-lymphocyte ratio, Serum albumin, Blood glucose) between the 3 groups.
4. To compare patient satisfaction scores between the three groups.
|
24 hours after extubation.
For stress markers- 6 hours and 24 hours after extubation |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
10/07/2021 |
Date of Study Completion (India) |
31/01/2022 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
none |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The laparoscopic technique is the standard of care for cholecystectomy surgery. Although considered a minimally invasive procedure, it results in moderate to severe immediate postoperative pain. Postoperative pain consists of both somatic and visceral pain components. In addition to predominant visceral pain, nearly half of all patients suffer from shoulder pain. Due to multiple sources of pain multimodal analgesia approaches have been used. Narcotic medications like opioids help in reducing somatic and visceral pain but they are associated with increased postoperative nausea and vomiting, ileus, sedation, and delayed hospital discharge. Blocks like Transverse abdominis plane block and oblique subcostal TAP block only help in reducing the somatic pain and have no effect on the visceral component of pain. As the erector spinae fascia extends from the nuchal fascia cranially to the sacrum caudally, the local anaesthetic drugs extend through several levels, and the block can be effective over a large area. Better postoperative analgesia, reduced nausea, vomiting and reduced surgical stress is expected to enhance the recovery of patients after surgery and lead to greater patient satisfaction. So our study intends to find out the effectiveness of USG-ESPB using different concentrations of bupivacaine on postoperative pain management, reducing perioperative surgical stress and improving patient satisfaction in patients undergoing laparoscopic cholecystectomy. The procedure shall be performed after inducing general anaesthesia to the patient for surgery. Following intubation, the patient shall be placed in a lateral position and USG guided block shall be given bilaterally at the level of T7 spinous process. The following parameters shall be recorded in the first 24 hours: NRS score at the surgical site at rest, on movement and on deep breathing at various time intervals, shoulder pain, intraoperative fentanyl requirements, total postoperative analgesic consumption, the incidence of nausea and vomiting and complications related to ESP block. A patient satisfaction survey shall be done on all patients.
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