| CTRI Number |
CTRI/2024/12/078742 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study looked at whether Clonidine or Dexmedetomidine, when added to Ropivacaine, gives better pain relief for people having gallbladder surgery |
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Scientific Title of Study
|
Comparison of the efficacy of Clonidine and Dexmedetomidine as adjuvants to Ropivacaine in bilateral erector spinae plane block in patients undergoing laparoscopic cholecystectomy - A randomised 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 |
Kondaveeti Anusha |
| Designation |
Senior resident |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Department of Anesthesia, ILBS hospital, D1, Sector D, Vasant Kunj
South West DELHI 110070 India |
| Phone |
9491213659 |
| Fax |
|
| Email |
anookondaveeti999@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Deepak. K. Tempe |
| Designation |
Head of the Department |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Depart of Anaesthesiology, ILBS hospital, D1, Sector D, Vasant Kunj
South West DELHI 110070 India |
| Phone |
9718599401 |
| Fax |
|
| Email |
tempedeepak@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kondaveeti Anusha |
| Designation |
Senior resident |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Department of Anaesthesiology , ILBS hospital, D1, Sector D, Vasant Kunj, New Delhi
South West DELHI 110070 India |
| Phone |
9491213659 |
| Fax |
|
| Email |
anookondaveeti999@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Institute of liver and biliary sciences |
| Address |
D1, Sector D, vasant kunj, New Delhi, India, Pincode:110070, Country code: 91 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kondaveeti Anusha |
Department of Anaesthesiology, Institute of liver and biliary sciences |
D1, sector D, Vasant Kunj, New Delhi, India, 110070 South West DELHI |
9491213659
anookondaveeti999@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of liver and biliary sciences |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector spinae plane block |
Comparison between Clonidine and Dexmedetomidine |
| Intervention |
Erector spinae plane block |
The ESP block will be performed pre-induction using a portable ultrasound device with a 6-13 MHz transducer. Patients will be positioned laterally, and sedo-analgesia will be administered. The block will be applied at the T8/T9 level using an in-plane technique. Group D will receive 20 mL of 0.25% ropivacaine with dexmedetomidine, Group C will receive ropivacaine with clonidine, Group R will receive ropivacaine alone, and Group N will receive no block. (Dose is 20ml of 0.25% ropivacaine : 50mg). This is a single shot dose of local anesthesia. Pain will be monitored for 24hrs after the surgery.
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective unilateral laparoscopic cholecystectomy surgery
Agrees to participate in research
Age 18 - 65 years
BMI 25 - 35 kg/ m2
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Failure to comprehend visual analogue scale
Contraindications to intervention procedure (ESP block)
History of local anaesthetic allergy
Cardiovascular, respiratory, neurological or metabolic diseases, severe coagulopathy
History of chronic analgesic use
Failure of intervention procedures (ESP block)
History of alcohol and substance addiction
Known psychiatric disorders or use of psychiatric medications
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| clonidine and dexmedetomidine added as adjuvants to ropivacaine for ultrasound guided erector spinae plane block in laparoscopic cholecystectomy patients, prolong the duration of analgesia and improve patient comfort. |
24 hours |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of efficacy of clonidine and dexmedetomidine as adjuvants to 0.25% ropivacaine
Total dose of fentanyl consumption in the postoperative period
Comparison of intraoperative fentanyl required to suppress pain response
Comparison of time to first rescue analgesia (use of PCA)
Reduction in opioid related side effects such as nausea, vomiting, sedation
Comparison of side effects related to adjuvants like hypotension, bradycardia and sedation
Comparison of intraoperative hemodynamics between the groups
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
10/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Laparoscopic cholecystectomy is the gold standard for treating symptomatic gallstone disease, offering a less invasive approach that promotes early recovery and improved patient satisfaction. However, despite these benefits, postoperative pain remains significant, often leading to discomfort and limited mobility in the early recovery period. The primary sources of this pain include somatic pain from trocar insertion and visceral pain due to peritoneal stretching and diaphragmatic irritation caused by CO2 insufflation and increased intra-abdominal pressure. Ultrasound-guided erector spinae plane block (ESPB), a periparavertebral regional block, was initially introduced for managing thoracic neuropathic pain. It has since proven effective in reducing postoperative pain in various surgeries, including ventral hernia repair, breast surgeries, thoracotomies, and lumbar fusions. ESPB involves the ultrasound-guided injection of local anesthetic deep to the erector spinae muscle, in the paraspinal interfascial plane, offering advantages over neuraxial techniques and paravertebral blocks due to its lower risk profile and superficial application. ESPB has shown efficacy in laparoscopic cholecystectomy, with studies exploring the role of α2 agonists like clonidine and dexmedetomidine in peripheral nerve blocks for prolonging sensory and motor blockades and analgesia. Their mechanisms include centrally mediated analgesia, direct action on peripheral nerves, attenuation of inflammatory responses, and α2 β adrenoceptor-mediated vasoconstriction. However, their effects in fascial plane blocks are less studied. This study aims to compare the efficacy of clonidine and dexmedetomidine as adjuvants to ropivacaine in bilateral erector spinae plane blocks for laparoscopic cholecystectomy.
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