| CTRI Number |
CTRI/2022/06/043378 [Registered on: 21/06/2022] Trial Registered Prospectively |
| Last Modified On: |
20/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a comparative study of intraperitoneal instillation
of local anesthetic with different drugs after laparoscopic gall bladder removal pain |
|
Scientific Title of Study
|
a comparative study of intraperitoneal instillation of levobupivacaine with different adjuvants on post laparoscopic cholecystectomy pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenakshi |
| Designation |
Junior resident MD anesthesiology king George Medical college |
| Affiliation |
King George Medical college |
| Address |
Department of anesthesiology
Seminar room
kgmu Lucknow uttar pradesh 226003 India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9520514421 |
| Fax |
|
| Email |
meenakshi297196@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod srivastava |
| Designation |
Assistant professor MD anesthesiology |
| Affiliation |
King George Medical college |
| Address |
Department of anesthesiology kgmu Lucknow Uttar pradesh 226003 India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415795564 |
| Fax |
|
| Email |
vinod123.doctor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr meenakshi |
| Designation |
Junior resident MD anesthesiology King George Medical college |
| Affiliation |
King George Medical college |
| Address |
Department of anesthesiology kgmu Lucknow
Flat no 306 radiation courtyard near city station wazirganj
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9520514421 |
| Fax |
|
| Email |
meenakshi297196@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology
King George Medical college |
|
|
Primary Sponsor
|
| Name |
Dr meenakshi |
| Address |
Department of anesthesiology King George Medical college |
| 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 |
| Dr vinod srivastava |
King George Medical College |
Department of anesthesiology kgmu Lucknow uttar pradesh
Lucknow
UTTAR PRADESH |
9415795564
vinod123.doctor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King George Medical college Lucknow |
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 |
Companion of effectiveness of magnesium sulphate dexmedetomidine dexamethasone with local anesthetic in post operative pain |
Comparison of Levobupivacaine 50 ml 0.25% with Dexamethasone 0.1 mg/kg in 10 ml NS
Dexmedetomidine 1 microgram/kg in 10 ml NS
Magnesium sulphate 50mg/kg in 10 ml NS in postoperative pain upto 24 hours |
| Intervention |
Intraperitoneal instillation of levobupivacaine with different adjuvants like magnesium sulphate dexamethasone dexmedetomidine |
Intraperitoneal instillation of levobupivacaine with magnesium sulphate 50mg/kg in 10 ml NS
Dexamethasone 0.1mg/kg in 10 ml NS
Dexmedetomidine 1 microgram/kg in 10 ml NS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2
Patient giving consent
Patient having gall bladder stone |
|
| ExclusionCriteria |
| Details |
Patients not giving consent
Patient allergic to local anesthetic and study drugs
Duration of surgery more than 90 minutes
BMI more than 30 kg/m2
Patients with acute cholecystitis
Patients with cardiac pulmonary and neurological disease
Patients with deranged LFT and KFT
Procedure changed to open cholecystectomy
Patients on medication like steroids diclofenac optics for chronic pain
Abdominal drain will be placed
PA requiring any other analgesic other than diclofenac in post operative pain
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect on postoperative pain shoulder and abdominal following intraperitoneal instillation of levobupivacaine with three different adjuvants dexmetomidine dexamethasone and magnesium sulphate |
Postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of three adjuvants with levobupivacaine on time of first rescue analgesic
Total consumption of rescue analgesic in 24 hours in postoperative period
Bowel recovery and first Flatus pass
To see any untoward side effects |
Postoperative |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/06/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
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 Pain resulting from stretching of intraabdominal cavity peritoneal inflammation and diaphragmatic irritation caused by residual co2 can prolong hospital stay Many methods are there like local site infiltration transverse abdominal plane block post procedure saline lavage but these methods are not recommended unless basic analgesia is possible Intraperitoneal instillation of local anesthetic with different adjuvants can possibly overcome this postoperative pain
|