| CTRI Number |
CTRI/2024/07/071224 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A comparison of pain relief: using ropivacaine alone versus ropivacaine with dexmedetomidine in patients undergoing gallbladder removal through keyhole surgery. |
|
Scientific Title of Study
|
A comparative study of postoperative analgesic effect of
intraperitoneal instillation of ropivacaine alone and
ropivacaine with dexmedetomidine after 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 |
Amitha Anna Sajji |
| Designation |
PG resident |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Room no 14,14th floor
Diamond jubilee block-5th gate
Department of anesthesia
Jubilee Mission Medical College and Research Institute
Thrissur
KERALA
680005
India |
| Phone |
9496994320 |
| Fax |
|
| Email |
amithasajji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Mariam Koshi Thomas |
| Designation |
Proffessor and HOD |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Old Block, First floor
Maxmillian Kolbe Operation Theatre Complex (Ortho Operation Theatre)
Department of Anesthesia
Jubilee Mission Medical College and Research Institute
Thrissur
KERALA
680005
India |
| Phone |
9895266950 |
| Fax |
|
| Email |
drmariamt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amitha Anna Sajji |
| Designation |
PG resident |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Room no 14,14th floor
Diamond jubilee block-5th gate
Department of Anesthesia
Jubilee Mission Medical College and Research Institute
Thrissur
KERALA
680005
India |
| Phone |
9496994320 |
| Fax |
|
| Email |
amithasajji@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jubilee Mission Medical College and Research Institute
East Fort Thrissur Kerala India
pin-680005 |
|
|
Primary Sponsor
|
| Name |
Dr Amitha Anna Sajji |
| Address |
Room no 14-14th floor
Diamon Jubilee block-5th gate
Jubilee Mission Medical College and Research Institute
Thrissur
Kerala |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrAmitha Anna Sajji |
Jubilee Mission Medical College and Research Institute |
Old block,First floor,Maxmillian Kolbe Operation Theatre(Ortho Operation Theatre)Department of anesthesia
Thrissur
KERALA |
9496994320
amithasajji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,JMMC & RI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraperitoneal instillation of drugs after laparoscopic cholecystectomy |
Totally 80 patients in the
inclusion criteria undergoing elective laparoscopic cholecystectomy under general
anaesthesia will be divided into two groups and are age matched. Group R (those who
receive 0.2% Ropivacaine 40 ml) and Group RD (those who receive 0.2% Ropivacaine
40ml +Dexmedetomidine 1 mcg/kg).
Study drugs will be prepared by an anaesthesiologist who managed and followed up
the patient. At the end of the surgery, the study solution will be given intraperitoneally
before removal of the trocar in Trendelenburg’s position, into the hepato
diaphragmatic space, on gallbladder bed and near and above hepatoduodenal ligament.
The postoperative pain will be assessed using the VAS score at 0 h, 2 h, 4 h, 6 h, 12 h
and 24 h postoperatively.
Time to first analgesic requirement after completion of laparoscopic cholecystectomy,
the total analgesic requirement in the first 24 h postoperatively for each patient will be
recorded.
â–ª Incidence of shoulder pain in the postoperative period
â–ª Heart rate (HR), Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
and SPO2 will be recorded 5 min before induction and every 5 min for the first 30 min
after the administration of drugs.
â–ª Sedation is assessed by Ramsay Sedation Scale. |
| Comparator Agent |
Ropivacaine alone versus Ropivacaine plus Dexmedetomidine |
Totally 80 patients in the
inclusion criteria undergoing elective laparoscopic cholecystectomy under general
anaesthesia will be divided into two groups and are age matched. Group R (those who
receive 0.2% Ropivacaine 40 ml) and Group RD (those who receive 0.2% Ropivacaine
40ml +Dexmedetomidine 1 mcg/kg).
The postoperative pain will be assessed using the VAS score at 0 h, 2 h, 4 h, 6 h, 12 h
and 24 h postoperatively.
Time to first analgesic requirement after completion of laparoscopic cholecystectomy,
the total analgesic requirement in the first 24 h postoperatively for each patient will be
recorded.
â–ª Incidence of shoulder pain in the postoperative period
â–ª Heart rate (HR), Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
and SPO2 will be recorded 5 min before induction and every 5 min for the first 30 min
after the administration of drugs.
â–ª Sedation is assessed by Ramsay Sedation Scale. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA Grade I and II Patients
2)Age group of 18-60 years
3)Those patients scheduled for laparoscopic cholecystectomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1) ASA grade III and IV patients
2) History of allergy to study drugs.
3) cardiac pulmonary hepatic or renal disorders
4) Patient refusal
5) Morbid obese patients
6) Pregnant and lactating females
7) Baseline heart rate less than 50
8)Patients needing conversion to open cholecystectomy will be excluded
from the final analysis |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the intensity of postoperative pain by visual analogue scale in the first 24
hours following intraperitoneal instillation of ropivacaine alone versus ropivacaine plus
dexmedetomidine after laparoscopic cholecystectomy. |
Oh,2h,4h,6h,12h and 24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time to first rescue analgesia between the two groups. |
24 hours |
| T0 compare the total dose of analgesic used in the first 24 hours between the two groups. |
24 hours |
| To assess the occurrence of any adverse side effects between the two 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
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2024 |
| 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="0"
Months="6"
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 cholecystectomy is currently the most accepted surgical technique for
cholelithiasis.Intraperitoneal injections of local anaesthetic are used to minimize postoperative pain after
laparoscopic surgery .There are studies available on intraperitoneal instillation of local anaesthetic bupivacaine
along with adjuvants for postoperative analgesia following laparoscopy cholecystectomy,
but only very few on postoperative analgesia with intraperitoneal instillation of ropivacaine
which is a local anaesthetic with an improved safety profile when compared to bupivacaine.
Hence my study is performed to compare the postoperative analgesic effect following the
intraperitoneal instillation of ropivacaine alone versus ropivacaine plus dexmedetomidine in
patients undergoing laparoscopic cholecystectomy. The postoperative pain will be assessed using the VAS score at 0 h, 2 h, 4 h, 6 h, 12 h
and 24 h .The secondary outcomes measured are the time to first rescue analgesia and the total analgesics used in first 24 hours as well as incidence of any adverse events. |