CTRI Number |
CTRI/2024/02/063085 [Registered on: 23/02/2024] Trial Registered Prospectively |
Last Modified On: |
22/02/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [Erector spinal plane block] |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To evaluate bilateral versus unilateral erector spinae plane block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy |
Scientific Title of Study
|
To evaluate bilateral versus unilateral erector spine plane block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Kirti Kshetrapal |
Designation |
Professor |
Affiliation |
Pt B D Sharma PGIMS Rohtak |
Address |
Department of Anaesthesiology and Critical Care, PGIMS Rohtak
Rohtak HARYANA 124001 India |
Phone |
9215650615 |
Fax |
|
Email |
Kamalkirti47@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Kirti Kshetrapal |
Designation |
Professor |
Affiliation |
Pt B D Sharma PGIMS Rohtak |
Address |
Department of Anaesthesiology and Critical Care, PGIMS Rohtak
HARYANA 124001 India |
Phone |
9215650615 |
Fax |
|
Email |
Kamalkirti47@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Urmi Malik |
Designation |
Postgraduate student |
Affiliation |
Pt B D Sharma PGIMS Rohtak |
Address |
Department of Anaesthesiology and Critical Care, PGIMS Rohtak
Rohtak HARYANA 124001 India |
Phone |
8607642799 |
Fax |
|
Email |
Urmi.malik1997@gmail.com |
|
Source of Monetary or Material Support
|
Pt B D Sharma, PGIMS Rohtak |
|
Primary Sponsor
|
Name |
Pt B D Sharma PGIMS Rohtak |
Address |
Department of Anaesthesiology and Critical Care, PGIMS Rohtak |
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 |
Dr Urmi Malik |
Pt.B D Sharma PGIMS, Rohtak |
Department of Anaesthesiology and Critical Care, 2nd floor Modular OT Complex Rohtak HARYANA |
8607642799
Urmi.malik1997@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Biomedical Research Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K80||Cholelithiasis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Bilateral erector spinae plane block |
Under all aseptic precautions, the probe will be placed longitudinally 3cm lateral to the T8 level.Following identification of the transverse process and erector spinae muscle, the needle will be inserted with in-plane approach from cranial to caudal direction.Confirmation of correct needle tip placement will be done by injecting 5ml saline and visualing the lifting of erector spinae muscle away from the transverse process. Twenty millimetres of 0.25%bupivacaine will then be administered bilaterally in group B patients. |
Intervention |
Unilateral Erector spinae plane block |
Under all aseptic precautions, the probe will be placed longitudinally 3cm lateral to the T8 level.Following identification of the transverse process and erector spinae muscle , the needle will be inserted with in-plane approach from cranial to caudal direction.Confirmation of correct needle tip placement will be done by injecting 5ml saline and visualising the lifting of erector spinae muscle away from the transverse process.twenty millimetres of 0.25%bupivacaine will the be administered on the right side in group U patients. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Adult patients of either gender, aged 18-60 years belonging to American society of Anaesthesiologists (ASA) I-II scheduled for elective laparoscopic cholecystectomy under general anaesthesia will be included in the study. |
|
ExclusionCriteria |
Details |
Patients with :
Contraindications to regional anaesthesia such as coagulopathy, infection at the site of puncture etc.
Known history of hypersensitivity/anaphylaxis/contraindications to bupivacaine or its components
Pregnancy
Mental disorders/o
Illness
BMI >35kg/m2
Chronic drug/analgesic abuse
Refusal to give consent
Severe renal or liver diseases
Will be excluded from the study. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare post operative numerical rating scale (NRS) for pain following bilateral versus right sided ESPB in patients undergoing laparoscopic cholecystectomy. |
Score at rest and score on coughing at
15 min
1 hr
6 hr
24 hr |
|
Secondary Outcome
|
Outcome |
TimePoints |
Duration of postoperative analgesia |
Duration of postoperative analgesia (in hours) |
Total analgesic consumption in 24hrs |
Total analgesic consumption in 24hrs |
Postoperative nausea and vomiting |
Postoperative nausea and vomiting |
Block related complications, if any |
Block related complications, if any |
|
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
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
|
11/03/2024 |
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)
|
Closed to Recruitment of Participants |
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
|
The laparoscopic technique for cholecystectomy surgery has gained popularity in recent years and it is the most commonly performed surgical procedure for benign biliary diseases. Being minimally invasive, it offers advantage of shorter hospital stay, faster recovery, lesser pain and reduced perioperative complications as compared with open techniques performed for biliary diseases.Laparocopic cholecystectomy (LC) produces significant moderate to severe immediate postoperative pain despite being a minimally invasive technique. Furthermore, postoperative pain can affect physical and mental health of the patient and may lead to secondary complications such as nausea, vomiting, slowed bowel movements, muscle spasms, thrombosis, cardiopulmonary complications and delayed recovery of organ function. Perioperative pain management goals are to alleviate suffering, discomfort, early mobilization, rapid recovery, rapid discharge and most importantly patient satisfaction.4 Due to multiple pain sources, multimodal analgesia approaches with non steroidal inflammatory agents, opioids, dexamethasone, gabapentin, local anesthetics infiltration to port sites and regional anesthetic techniques such as epidural, transversus abdominis plane block, erector spinae plane block, oblique subcostal transversus abdominis plane block and paravertebral blocks have been used for pain management in perioperative period following LC.Ultrasound-guided interfascial plane blocks are being commonly used for management of postoperative pain and one of the such novel technique is the USG guided erector spinae plane block (ESPB). USG guided erector spinae plane block has emerged as a well established block for providing perioperative and postoperative analgesia in LC patients.ESPB has shown its value and efficacy in acute as well as in chronic pain management. All blocks will be performed in the sitting position. All the blocks will be performed 20min prior to surgery in sitting position at T8 level in the preoperative room. Under all aseptic precautions, the probe will be placed longitudinally 3 cm lateral to the T8 level. Following identification of the transverse process and erector spinae muscle, the needle will be inserted with in-plane approach from cranial to caudal direction. Confirmation of correct needle tip placement will be done by injecting 5ml saline and visualizing the lifting of the erector spinae muscle away from the transverse process. Twenty milliliter of 0.25% bupivacaine will be then administered on the right side in group U patients and bilaterally at the T8 level in group B patients. The spread of the injectate beneath the erector spinae muscle will be visualized in both the cranial and caudal directions. ESPB will be given bilaterally in patients of group B and unilaterally(right side) in patients of group U. Time at which the block is given will be noted (To). |