| CTRI Number |
CTRI/2019/08/020837 [Registered on: 22/08/2019] Trial Registered Prospectively |
| Last Modified On: |
22/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To assess the efficacy of intraperitoneal 0.25% levobupivacaine for postoperative analgesia following laparoscopic cholecystectomy |
|
Scientific Title of Study
|
A prospective randomised double blinded controlled study to assess the efficacy of intraperitoneal 0.25% levobupivacaine for postoperative analgesia 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 |
Pavithra Palaniappan |
| Designation |
Post graduate |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Department of anaesthesiology and pain mdicine
Sri Ramachandra institute of higher education and research
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
7502891567 |
| Fax |
|
| Email |
pavicardo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thamaraiselvi |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Department of Anaesthesiology and Pain medicine
Sri Ramachandra institute of higher education and research
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9841552333 |
| Fax |
|
| Email |
thames25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pavithra Palaniappan |
| Designation |
Post graduate |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Department of anaesthesiology and pain medicine
Sri Ramachandra institute of higher education and research
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
7502891567 |
| Fax |
|
| Email |
pavicardo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pavithra Palaniappan
Room no:244
NRI girls hostel
Sri Ramachandra institute of higher education and research
Porur
Chennai 600116 |
|
|
Primary Sponsor
|
| Name |
Pavithra Palaniappan |
| Address |
Room no:244
NRI girls hostel
Sri Ramachandra institute of higher education and research
Chennai |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| Pavithra Palaniappan |
Sri Ramachandra Institute of higher education and research |
Department of anaesthesiology and pain medicine
Sri Ramachandra Institute of higher education and research
Porur
Chennai
Chennai
TAMIL NADU |
7502891567
pavicardo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.25% levobupivacaine |
30 ml Intraperitoneal 0.25% levobupivacaine is given before removal of the laparoscopic ports. Pain score(VAS) is assessed for first 24 hours is assessed.
Time for first request for anlgesia and total dose of analgesia used in first 24 hours is noted. Inj.Tramadol 50 mg i.v. is used as rescue analgesia. |
| Comparator Agent |
Normal saline |
30 ml Intraperitoneal normal saline is given before removal of the laparoscopic ports. Pain score(VAS) is assessed for first 24 hours is assessed.
Time for first request for anlgesia and total dose of analgesia used in first 24 hours is noted. Inj.Tramadol 50 mg i.v. is used as rescue analgesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing laparoscopic cholecystectomy
Patients of ASA1 and ASA 2 |
|
| ExclusionCriteria |
| Details |
Patients allergic to local anaesthetics
Patients with severe cardiac, pulmonary, and neurological disease
Patients in whom procedure has to be converted to open cholecystectomy
Patients in whom abdominal drain will be kept
Patients of weight less than 50 kg
Patients not willing to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time for the first request of analgesia within first 24 hours |
Time for the first request of analgesia within first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative VAS score
Total no. of analgesics used in first 24 hrs |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
26/08/2019 |
| Date of Study Completion (India) |
12/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
12/02/2020 |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Laparoscopic cholecystectomy is currently the most practised surgical technique for cholelithiasis. After laparoscopic cholecystectomy pain is due to somatic pain, visceral pain and referral pain. Postoperative analgesia should cover all these factors. In this study somatic pain is attended with port site local infiltration. Visceral pain and referral pain if left unattended then the patient will need intravenous analgesics. Intraperitoneal local anaesthetic will attend to visceral pain and referral pain. The study group patients get intraperitoneal local anaesthetic(0.25% levobupivacaine) and placebo group receives intraperitoneal normal saline. Postoperative pain is assessed using VAS score and postoperative intravenous analgesic usage on patient’s request in the first 24 hours is recorded. |