| CTRI Number |
CTRI/2023/11/059493 [Registered on: 03/11/2023] Trial Registered Prospectively |
| Last Modified On: |
02/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of effects of intraperitoneal injection of dexamethasone with fentanyl as an additive to ropivacaine in post operative pain relief for laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Comparison of effects of intraperitoneal dexamethasone with fentanyl as an adjuvant to ropivacaine in post operative analgesia for 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 |
Mounika devi peela |
| Designation |
1st year pg MD Anaesthesiology |
| Affiliation |
Ks hegde Medical Academy |
| Address |
Department of Anaesthesiology
1st floor, near OT complex
Ks hegde Medical Academy,
Derakatte,
Mangaluru
Dakshina Kannada
KARNATAKA
533106
India |
| Phone |
9989775784 |
| Fax |
|
| Email |
mounikadevi.peela@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayathri Bhat |
| Designation |
Professor in Anaesthesiology |
| Affiliation |
Ks hegde Medical Academy |
| Address |
Department of Anaesthesiology,
1st floor, near OT complex
Ks hegde Medical Academy,
Derakatte,
Mangaluru
Dakshina Kannada
KARNATAKA
533106
India |
| Phone |
9989775784 |
| Fax |
|
| Email |
gayathribhat@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mounika devi peela |
| Designation |
1st year pg MD Anaesthesiology |
| Affiliation |
K. S. Hegde Medical Academy |
| Address |
Department of Anaesthesiology
1st floor, near OT complex
K. S. Hegde Medical Academy,
Derakatte,
Mangaluru
Dakshina Kannada
KARNATAKA
533106
India |
| Phone |
9989775784 |
| Fax |
|
| Email |
mounikadevi.peela@gmail.com |
|
|
Source of Monetary or Material Support
|
| K. S. Hegde Medical Academy |
|
|
Primary Sponsor
|
| Name |
Department of anesthesiology |
| Address |
Ks hegde Medical college,
Derlakatte,
Karnataka |
| 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 |
| Mounika devi |
K. S. Hegde Medical Academy |
K. S. Hegde Medical Academy,
Derlakatte,
Mangalore
Dakshina Kannada
KARNATAKA |
09989775784
mounikadevi.peela@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, K.S.Hegde Medical Academy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Grade I and II
2. Patients undergoing elective laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate in the study
2. Patients with known allergy to study drugs
3. Pregnant and lactating ladies
4. Uncontrolled hypertension and diabetes
5. Surgeries converted into open cholecystectomy
6. Patients with body weight < 35 kg and > 100 kg
7. Known case of chronic abdominal pain due to other causes
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the postoperative analgesia by assessing pain score(NRS) |
24 hours after shifting to post operative ward |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to first request of rescue analgesia
2. 24 hour Post operative analgesic requirement
3. Incidence of post operative nausea and vomiting
4. Hemodynamic status in postoperative period
5. Incidence of adverse effects, if any |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
12/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/10/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
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
|
After approval from the institutional ethics committee, Patients satisfying the inclusion criteria will be enrolled after obtaining informed written consent. During pre-anaesthetic evaluation on the day before surgery, Premedication with tablet diazepam 5mg for <50 kg body weight and 10mg for >50 kg body weight and pantoprazole 40 mg night before and in the morning on the day of surgery will be prescribed as per routine institutional protocol. Numerical Rating Scale ( NRS) will be explained to the patient during preoperative evaluation. Once the patient is shifted to the operation theatre, standard monitoring with ECG, SpO2, NIBP and EtC02 will be done. Fluid will be started after securing a suitable intravenous cannula. Induction and maintenance of anaesthesia will be done according to the standard institutional anaesthesia protocol and a nasogastric tube of appropriate size will be inserted. As per the institutional protocol, Analgesic solution containing local anaesthetic with adjuvant will be administered intraperitoneally in Trendelenberg’s position after the removal of the gallbladder and before the removal of the trocar. The solution will be instilled by operating surgeon through trocar, as per discretion of the concerned anaesthesists into the hepato-diaphragmatic area, on the gall bladder bed, close to and above the hepatoduodenal ligament. The extubation will be carried out after adequate reversal of neuromuscular blockade, in accordance with institutional standard anaesthesia protocol. The patient will be shifted to the post anesthesia care unit (PACU) after the removal of the nasogastric tube. The degree of postoperative pain will be assessed using the Numerical Rating Scale at 30 minutes, 1 hour, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours postoperatively. When patient complains of pain or NRS score 4 and above, diclofenac aqueous 75 mg infusion will be given as rescue analgesic. Time to 1st rescue analgesic and 24 hours post operative analgesic requirement will be noted. If patient complains of nausea and vomiting, injection Ondansetron 4mg will be given intravenously and incidence of PONV will be doccumented. Any adverse effects in postoperative period will be treated accordingly and doccumented. |