FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/11/022129 [Registered on: 25/11/2019] Trial Registered Prospectively
Last Modified On: 22/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Intraperitoneal administration (giving drug into the abdominal cavity) of Ropivacaine (local anaesthetic) with Dexmedetomidine (sedative) Versus Ropivacaine with Ketamine (sedative) for Post Operative Pain Relief Following Laparoscopic Cholecystectomy 
Scientific Title of Study   A Randomized Controlled Study for Evaluation of the Efficacy of Intraperitoneal Instillation of Ropivacaine with Dexmedetomidine Versus Ropivacaine with Ketamine for Post Operative Pain Relief Following Laparoscopic Cholecystectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchi Kapoor 
Designation  Associate Professor 
Affiliation  UCMS and GTBH 
Address  Room no 331A 3rd Floor OT Block Dept of Anaesthesiology UCMS and GTB Hospital New Delhi

North East
DELHI
110095
India 
Phone  9560678023  
Fax    
Email  rudoc@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ruchi Kapoor 
Designation  Associate Professor 
Affiliation  UCMS and GTBH 
Address  Room no 331A 3rd Floor OT Block Dept of Anaesthesiology UCMS and GTB Hospital New Delhi

North East
DELHI
110095
India 
Phone  9560678023  
Fax    
Email  rudoc@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Steffi Dua 
Designation  Post Graduate Resident 1st year 
Affiliation  UCMS and GTBH 
Address  ICU 2nd floor Dept of Anaesthesiology UCMS and GTB Hospital New Delhi

North East
DELHI
110095
India 
Phone  9910040311  
Fax    
Email  steffi.dua05@gmail.com  
 
Source of Monetary or Material Support  
UCMS and GTB Hospital 
 
Primary Sponsor  
Name  UCMS and GTB Hospital 
Address  Deptt of Anaesthesiology, Dilshad Garden New Delhi 110095 
Type of Sponsor  Government 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 Ruchi Kapoor  UCMS & GTB Hospital  Room 331A, 3rd Floor, OT Block, Dept. of Anaesthesiology, UCMS and GTB Hospital, Dilshad Garden, New Delhi 110095
North East
DELHI 		 9560678023

rudoc@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee--Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80||Cholelithiasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group R Intraperitoneal instillation of 0.2% Ropivacaine  Intraperitoneal instillation of 0.2% plain Ropivacaine in a total volume of 40 ml of instilled solution after removal of gall bladder 
Comparator Agent  Group RD Intraperitoneal instillation of 0.7µg/kg Dexmedetomidine mixed with 0.2% Ropivacaine   Intraperitoneal instillation of 0.7µg/kg Dexmedetomidine mixed with 0.2% Ropivacaine in a total volume of 40 ml of instilled solution after removal of gall bladder 
Comparator Agent  Group RK Intraperitoneal instillation of 0.5 mg/kg Ketamine mixed with 0.2% Ropivacaine  Intaperitoneal instillation of 0.5 mg/kg Ketamine mixed with 0.2% Ropivacaine in a total volume of 40 ml of instilled solution after removal of gall bladder 
Intervention  Intraperitoneal instillation of local anaesthetic agent alone or with adjuvant  After the removal of the gall bladder a total of 40 ml study drug solution will be instilled intaperitoneally 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients of either gender giving consent for the study and aged 20-55 years belonging to ASA grade I or II scheduled for elective laparoscopic cholecystectomy under general anaesthesia. 
 
ExclusionCriteria 
Details  1.Patients with cardiovascular, pulmonary, psychological or neurological diseases
2.Patients who are known to be epileptic
3.Patients who have an increase in intracranial tension
4.Patients with known allergies to the study drugs
5.Patients with abnormalities like heart block, left bundle branch block
6.Patients in whom the procedure will be converted to open cholecystectomy
7.Obese patients (BMI more than or equal to 30)
8.Patients in whom subhepatic drain is inserted after the removal of gall bladder.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to demand of first dose of rescue analgesia in the three groups  Once, during first 24 hours, when patient complains of pain and NRS is more than or equal to 4 
 
Secondary Outcome  
Outcome  TimePoints 
Time to extubation.
 		 Once, at the time of tracheal extubation 
Hemodynamic parameters at the time of extubation  Intraoperative, Immediate postoperative, 5 mins, 10 mins, 15 mins, 30 mins, 1h, 1 h 30 mins, 2h, 3h, 4h, 5h, 6h, 7h, 8h
 
Post-operative pain using Numeric Rating Scale (NRS)- Static and Dynamic.  30 min, 1 h, 2h, 3h, 4 h, 6h, 8 h, 12 h, 18 h and 24 h postoperatively 
Total dose of rescue analgesia required  First 24 hours 
Any adverse effects  first 24 hours
 
To assess the quality of post operative pain using Revised American Pain Society Patient Outcome Questionnaire.  After 24 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   25/11/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

RATIONALE: Intraperitoneal local anaesthetic instillation is a well established technique for pain relief in laparoscopic cholecystectomy with Bupivacaine being a commonly used drug in most of the studies. Ropivacaine has been used of late and with addition of adjuncts it provides adequate postoperative pain relief. Dexmedetomidine has been successfully used as an adjunct to ropivacaine for intraperitoneal instillation with prolonged duration of postoperative analgesia. Intraperitoneal Ketamine alone or with Bupivacaine has been found to have prolonged duration of analgesia. However, no study is available in literature which compares the efficacy of these two drugs as adjuncts to Ropivacaine for postoperative pain relief. Therefore, the present randomized double blinded controlled study is designed to compare the efficacy of intraperitoneal instillation of Ropivacaine with Dexmedetomidine versus Ropivacaine with Ketamine for postoperative pain relief following laparoscopic cholecystectomy.

AIM: To compare the efficacy of intraperitoneal instillation of Ropivacaine with Dexmedetomidine versus Ropivacaine with Ketamine for postoperative pain relief following laparoscopic cholecystectomy

OBJECTIVES

Primary Objective: To compare the time to demand of first dose of rescue analgesic between the three groups.

Secondary Objective:

To compare-

1.    Time to extubation.
2.    Hemodynamic parameters at the time of extubation
3.    Post-operative pain using Numeric Rating Scale (NRS).
4.    Total dose of rescue analgesia required in 24 hours
5.    Any adverse effects
6.    To assess the quality of post operative pain using Revised American Pain Society Patient Outcome Questionnaire.

MATERIALS AND METHODS

Place of study:

The study will be conducted in the Department of Anaesthesiology, Critical Care & Pain Medicine at University College of Medical Sciences and G.T.B Hospital, Shahdara, Delhi-95 after getting approval from the Institutional Ethics Committee-Human Research (IEC-HR). Informed written consent will be obtained from each patient willing to participate in the study.

Study design: A randomized double blinded controlled study

Duration of Study: Nov 2019 to April 2021

Blinding: Study drugs will be prepared by an independent anaesthesiologist and medication will be administered as per the group allocated. Both patient and observer will not be aware of the group or medication.

Participants: Total 60 patients, 20 in each group

Inclusion Criteria:

Patients having following criteria will be included in the study:

Patients of either gender giving consent for the study and aged 20-55 years belonging to ASA grade I or II scheduled for elective laparoscopic cholecystectomy under general anaesthesia.

Exclusion Criteria:

1.    Patients with cardiovascular, pulmonary, psychological or neurological diseases
2.    Patients who are known to be epileptic
3.    Patients who have an increase in intracranial tension
4.    Patients with known allergies to the study drugs
5.    Patients with abnormalities like heart block, left bundle branch block
6.    Patients in whom the procedure will be converted to open cholecystectomy
7.    Obese patients (BMI more than or equal to 30)
8. Patients in whom subhepatic drain is inserted after the removal of gall bladder.

 

 

Allocation:

Sixty patients fulfilling the above mentioned selection criteria will be divided into the following two groups by a computer generated random number chart.


Group R (n=20) [Control group]: Each patient will receive 0.2% plain Ropivacaine in a total volume of 40 ml of instilled solution.


Group RD (n=20): Each patient will receive 0.7µg/kg Dexmedetomidine mixed with 0.2% Ropivacaine in a total volume of 40 ml of instilled solution.


Group RK (n=20): Each patient will receive 0.5 mg/kg Ketamine mixed with 0.2% Ropivacaine in a total volume of 40 ml of instilled solution.


Standard general anaesthesia will be given to every patient participating in the study and after surgery, time to demand of first dose of analgesia, total dose of rescue analgesia and hemodynamic parameters will be recorded. Any side effects during the post operative period will also be noted.

 

OUTCOME MEASURES:

Primary outcome: Time to demand of first dose of rescue analgesia in the three groups

Secondary outcome: To compare in the three groups:

1.    Time to extubation.
2.    Hemodynamic parameters at the time of extubation
3.    Post-operative pain using Numeric Rating Scale (NRS).
4.    Total dose of rescue analgesia required in 24 hours
5.    Any adverse effects
6.    To assess the quality of post operative pain using Revised American Pain Society Patient Outcome Questionnaire.

 

STATISTICAL ANALYSIS:

One time quantitative measurements will be compared by one way ANOVA followed by Tukey’s test and repeatedly measured by repeated measure ANOVA followed by Dunnett’s test. Qualitative parameters will be compared by Chi-square test. p value of < 0.05 will be considered as significant. This analysis will be carried out in SPSS 20.0.

 
Close