| CTRI Number |
CTRI/2025/11/097158 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study of efficacy of Ropivacaine 0.25 versus Ropivacaine 0.375 with dexmedetomidine as adjuvant in ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy |
|
Scientific Title of Study
|
A comparative study of efficacy of Ropivacaine 0.25 percent versus Ropivacaine 0.375 percent with dexmedetomidine as adjuvant in ultrasound-guided erector spinae plane block for postoperative analgesia in 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 |
Jaswanth M D |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anesthesia, Ground Floor, Sapthagiri Institute of Medical
Sciences and Research Centre, Navy Layout, Hesaraghatta Main
Road, Chikkabanavara, Bangalore
Bangalore KARNATAKA 560090 India |
| Phone |
8310552833 |
| Fax |
|
| Email |
jaswanth.w32@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Narendra Babu M C |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anesthesia, Ground Floor, Sapthagiri Institute of Medical
Sciences and Research Centre, Navy Layout, Hesaraghatta Main
Road, Chikkabanavara, Bangalore
Bangalore KARNATAKA 560090 India |
| Phone |
8310552833 |
| Fax |
|
| Email |
narendrababuchanappa@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Jaswanth M D |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anesthesia, Ground Floor, Sapthagiri Institute of Medical
Sciences and Research Centre, Navy Layout, Hesaraghatta Main
Road, Chikkabanavara, Bangalore
Bangalore KARNATAKA 560090 India |
| Phone |
8310552833 |
| Fax |
|
| Email |
jaswanth.w32@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support by Sapthagiri institute of medical sciences and research centre, Bengaluru 560090 |
| PG stipend by Sapthagiri institute of medical sciences and research centre, Bengaluru 560090 |
|
|
Primary Sponsor
|
| Name |
Sapthagiri institute of medical sciences and research centre Department of Anaesthesia |
| Address |
Hesarghatta Rd, Navy Layout, Chikkasandra, Chikkabanavara, Bengaluru, Karnataka 560090 |
| Type of Sponsor |
Private 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 Jaswanth M D |
Sapthagiri Institute of medical sciences and research centre |
Ground floor , Department of Anaesthesia.
15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090 Bangalore KARNATAKA |
8310552833
jaswanth.w32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri institute of medical sciences and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.25 percent versus 0.375 percent ropivacaine with a fixed dose of dexmedetomidine(50mcg) |
comparision between inj 0.25% versus 0.375% ropivacaine with a fixed dose of dexmedetomidine(50mcg)as adjuvant in ultrasound-guided Erector spinae plane block. Block is given before induction and patient is monitored for 24hrs after the completion of procedure |
| Intervention |
ultrasound-guided Erector spinae plane block |
ultrasound-guided Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy. Block is given before induction and patient is monitored for 24hrs after the completion of procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Age 18-65 years, both sexes
2 ASA physical status 1 and 2
3 Scheduled for elective laparoscopic cholecystectomy
4 Patients willing to give informed consent. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of 0.25% versus 0.375% ropivacaine with a fixed dose of dexmedetomidine as adjuvant in ultrasound-guided Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy |
Postoperatively, VAS scores will be recorded at 1, 5min, 10min, 30min , 1hr , 2hr , 4hrs , 8hrs ,12hrs and 24 hours, and patients will be monitored for nausea, vomiting, sedation, respiratory depression, and shoulder pain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
21/11/2025 |
| 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="20" Months="1" 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
|
Laparoscopic abdominal surgery offers numerous advantages including improved early postoperative ambulation and reduced surgical trauma leading to faster recovery and fewer complications compared with open surgery However despite these benefits patients frequently experience significant postoperative pain especially in the early recovery period which can hinder mobilization increase opioid consumption and contribute to chronic pain development Effective postoperative analgesia is therefore essential for patient comfort accelerated rehabilitation and minimization of opioidrelated adverse effects Multimodal analgesia strategies incorporating nonopioid medications and regional nerve blocks have become standard for managing pain after laparoscopic procedures The ultrasoundguided erector spinae plane ESP block first described by Forero et al in 2016 is an interfascial plane block that provides both visceral and somatic analgesia by diffusion of local anesthetic into the paravertebral and epidural spaces Its simplicity under ultrasound guidance and favorable safety profile have led to rapid adoption in thoracic and abdominal surgeries Ropivacainea longacting amide local anestheticis preferred in regional techniques due to its lower cardiotoxicity and improved motorsensory separation The concentration of ropivacaine influences block quality duration and sideeffect profile however direct comparisons of different concentrations in ESP blocks for laparoscopic surgery remain scarce Dexmedetomidine a highly selective adrenergic agonist is increasingly used as an adjuvant in regional anesthesia When added to local anesthetic low dose dexmedetomidine prolongs sensory block duration enhances analgesia and reduces opioid requirements without significant hemodynamic instability The aim of this study is to compare the efficacy of 025 versus 0375 ropivacaine each with a fixed dose of dexmedetomidine as adjuvant in ultrasoundguided Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy |