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CTRI Number  CTRI/2024/04/065825 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 05/04/2024
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 efficacy of local application of local anesthetic drug with additives for pain relief after laparoscopic cholecystectomy surgery. 
Scientific Title of Study   Comparison of efficacy of intraperitoneal instillation of Ropivacaine with Dexmedetomidine vs Ropivacaine with Dexamethasone for pain relief after laparoscopic cholecystectomy; a prospective randomized, double blind study. 
Trial Acronym  Intraperitoneal infiltration  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Johnson P Abraham  
Designation  Junior resident  
Affiliation  St Johns medical College Hospital, Bangalore  
Address  Prayattumannil house Eraviperoor p o Thiruvalla Pathanamthitta Kerala

Pathanamthitta
KERALA
689542
India 
Phone  9074707170  
Fax    
Email  johnsonpabraham001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shilpa Bhimasen Joshi 
Designation  Assistant professor  
Affiliation  St Johns medical College Hospital, Bangalore  
Address  Flat no ebony 902 Salarpuria greenage apartments Next to Oxford dental college Bommanahalli
Department of Anaesthesiology St Johns medical College Hospital, Koramangala Bangalore
Bangalore
KARNATAKA
5600068
India 
Phone  9901405136  
Fax    
Email  drshilpa.josh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Johnson P Abraham  
Designation  Junior resident  
Affiliation  St Johns medical College Hospital, Bangalore  
Address  Prayattumannil house Eraviperoor p o Thiruvalla Pathanamthitta Kerala

Pathanamthitta
KERALA
689542
India 
Phone  9074707170  
Fax    
Email  johnsonpabraham001@gmail.com  
 
Source of Monetary or Material Support  
St Johns medical college hospital sarjapura road kormangala Bangalore 560034 
 
Primary Sponsor  
Name  Department of Anesthesiology 
Address  St Johns medical college hospital sarjapura road kormangala Bangalore 560034 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Johnson P Abraham   St Johns medical college hospital  Room no 3 2nd floor operation theatre St Johns medical college hospital sarjapura road kormangala Bangalore 560034
Bangalore
KARNATAKA 
9074707170

johnsonpabraham001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee , St johns medical College Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ropivacaine with Dexamethasone   After the completion of surgery, 40 ml of 0.2% Ropivacaine and 1 mcg/kg Dexmedetomidine will be instilled via trocar in the gallbladder fossa. Post-instillation hemodynamics such as systolic blood pressure, diastolic blood pressure, and heart rate will be recorded. Using NRS, the post-operative pain intensity will be measured for each patient at rest and during movement at 20 mins, 30mins, 1 hour, 2, 4, 6, 12, and 24 hours from the time of extubation. The time to first rescue analgesia, the total amount of analgesics administered over 24 hours, and the frequency of any side effects (Postoperative nausea vomiting and Sedation score) will be recorded. 
Comparator Agent  Ropivacaine with Dexmedetomidine  After the completion of surgery, 40 ml of 0.2% Ropivacaine and 1 mcg/kg Dexmedetomidine will be instilled via trocar in the gallbladder fossa. Post-instillation hemodynamics such as systolic blood pressure, diastolic blood pressure, and heart rate will be recorded. Using NRS, the post-operative pain intensity will be measured for each patient at rest and during movement at 20 mins, 30mins, 1 hour, 2, 4, 6, 12, and 24 hours from the time of extubation. The time to first rescue analgesia, the total amount of analgesics administered over 24 hours, and the frequency of any side effects (Postoperative nausea vomiting and Sedation score) will be recorded.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  ASA 1 and 2 patients
Age: 18 - 59 years
Patients undergoing elective laparoscopic cholecystectomy surgery
Patients who are able to interpret Numerical rating scale scoring
 
 
ExclusionCriteria 
Details  Presence of acute cholecystitis, and choledocholithiasis.
Patients on steroids
Pregnant and lactating women
Patients who have undergone previous abdominal surgery.
Laparoscopy getting converted to open surgeries
History of allergies to medications
Patient on beta blockers
Duration of surgery: more than 3 hours 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To access the postoperative analgesia using NRS score in patients undergoing laparoscopic cholecystectomy using intraperitoneal instillation of ropivacaine and dexmedetomidine vs ropivacaine and dexamethasone  Using NRS, the post-operative pain intensity will be measured for each patient at rest and during movement at 20 mins, 30mins, 1 hour, 2, 4, 6, 12, and 24 hours from the time of extubation. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the time required for the first rescue analgesia
And the total dose of rescue analgesia over 24 hours
 
NRS scoring will be recorded 1,2,4,6,12,24 hours post operaatively. 
To assess incidence of Postoperative nausea and vomiting and Sedation score  Patient will be assessed at 20, 30 mins, 1,2,4,6,12,24 hours 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/05/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 cholecystectomy (LC) has rapidly become the procedure of choice for routine gallbladder removal and is currently the most commonly performed major abdominal procedure. The patient complains more of visceral pain after laparoscopic cholecystectomy in contrast to the parietal pain experienced in open cholecystectomy. Dissection around the gallbladder bed and capno-peritoneum raises the intraperitoneal pressure, which results in peritoneal inflammation. This leads to visceral abdominal pain that gets aggravated by coughing, deep breathing, and movement.

Various multimodal approaches have been tried to ameliorate post-operative pain, which includes parenteral opioids, NSAIDs, analgesic patches, steroids, and local infiltration of local anaesthetics alone or with additives. Intraperitoneal instillation of local anaesthetics (LA) block the visceral afferent signals and modify visceral nociception. However, as LAs are short-acting, adding adjuvants will prolong the duration of anaesthesia and enhance the analgesic effect.


All parenteral medications have associated adverse effects like respiratory depression, drug dependence or abuse, nausea, vomiting, CNS side effects, etc. Local anesthetics have the added advantage that they cause fewer systemic side effects. Adding adjuvants increases the duration of the postoperative analgesic effect. Dexamethasone is a strong, long-acting glucocorticoid that is effective in relieving postoperative pain as well as postoperative nausea in laparoscopic surgeries.

Dexmedetomidine is an alpha-2 adrenergic agonist. Studies have shown that topical application of dexmedetomidine during nerve block can enhance the analgesic effect, reduce the dosage of local anaesthetic and improve the postoperative analgesic effect. There are very few studies comparing the efficacy of dexamethasone vs dexmedetomidine as adjuvants in intraperitoneal installation, and hence the following study is being undertaken.

 
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