| CTRI Number |
CTRI/2021/06/034068 [Registered on: 08/06/2021] Trial Registered Prospectively |
| Last Modified On: |
25/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
PAIN RELIEF FOLLOWING [APAROSCOPIC CHOLECYSTECTOMY |
|
Scientific Title of Study
|
POSTOPERATIVE ANALGESIC EFFECT OF INTRAPERITONEAL ROPIVACAINE WITH AND WITHOUT MAGNESIUM SULFATE IN LAPAROSCOPIC CHOLECYSTECTOMY-A PROSPECTIVE OBSERVATIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shamrood Ahamed |
| Designation |
DNB Resident Anasthesiology |
| Affiliation |
Baby Memorial Hospital |
| Address |
Baby Memorial Hospital
Indira Gandhi Road
Calicut
Baby Memorial Hospital
Indira Gandhi Road
Calicut
Kozhikode
KERALA
673004
India |
| Phone |
9495470746 |
| Fax |
|
| Email |
shamroodahamed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shamrood Ahamed |
| Designation |
DNB Resident Anasthesiology |
| Affiliation |
Baby Memorial Hospital |
| Address |
Baby Memorial Hospital
Indira Gandhi Road
Calicut
Baby Memorial Hospital
Indira Gandhi Road
Calicut
Kozhikode
KERALA
673004
India |
| Phone |
9495470746 |
| Fax |
|
| Email |
shamroodahamed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shamrood Ahamed |
| Designation |
DNB Resident Anasthesiology |
| Affiliation |
Baby Memorial Hospital |
| Address |
Baby Memorial Hospital
Indira Gandhi Road
Calicut
Baby Memorial Hospital
Indira Gandhi Road
Calicut
Kozhikode
KERALA
673004
India |
| Phone |
9495470746 |
| Fax |
|
| Email |
shamroodahamed@gmail.com |
|
|
Source of Monetary or Material Support
|
| DNB Resident Dissertation No financial support |
|
|
Primary Sponsor
|
| Name |
DNB Resident Dissertation No financial support |
| Address |
Baby Memorial Hospital
Kozhikode
Kerala State |
| Type of Sponsor |
Other [DNB Resident Thesis Protocol] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr MC Rajesh Senior Consultant Anasthesiologist |
Baby Memorial Hospital
Calicut, Kerala State |
| 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 MC Rajesh |
Baby Memorial Hospital,C BLOCK OPERATION THEATRE,DEPARTMENT OF ANAESTHESIA |
Indira Gandhi Road
Calicut
Kozhikode
KERALA |
9847001136
academy@babymhospital.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Baby Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K819||Cholecystitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ropivacaine 0.2 % plus magnesium 1 gram |
intraperitoneally 40 ml
after removal of gall bladder and 10 ml for port site instillation once |
| Comparator Agent |
ropivacaine 0.2% |
40 ml intraperitoneally once after removal of gall bladder and 10 ml for port site instillation once |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WHO ARE ASA CLASS 1 OR 2 UNDERGOING ELECTIVE LAPROSCOPIC SURGERY
BMI -18 TO 30 |
|
| ExclusionCriteria |
| Details |
PATIENT WITH ECG SHOWING CONDUCTION ABNORMALITIES
PREGNANT AND BREASTFEEDING
PATIENT ON BETA BLOCKERS
PATIENT WITH CHRONIC PAIN ON OPIOIDS AND OTHER ANALGESICS
HISTORY OF ALLERGY TO STUDY DRUGS
SURGERY DURATIONS MORE THAN THREE HOURS
CONVERSION TO OPEN PROCEDURE
EMERGENCY CHOLYCYSTECTOMY
PATIENTS REQUIRING COMMON BILE DUCT EXPLORATION |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the
1.duration of analgesia after intraperitoneal instillation of ropivacaine with and without magnesium sulphate,
2.Mean pain scores during 24 hour ,
3.total doses of rescue analgesics in each groups
4.type of pain. |
baseline,1 hour,2hour.6 hour,12 hour,24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objective
To study the post instillation hemodynamic changes in terms of heart rate(HR), systolic blood pressure(SBP), diastolic blood pressure(DBP), Oxygen saturation (SpO2), End Tidal Co2 (EtCO2) and postoperative nausea and vomiting(PONV) |
baseline,and every 2 hours for 24 hour. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2021 |
| Date of Study Completion (India) |
11/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="10" |
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)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 31-07-2021 and end date provided 31-12-2021?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
the study is to compare the duration of analgesia and incidence of pain after intraperitoneal instillation of ropivacaine with and without magnesium sulphate in patints undergoing elective laparoscopic cholecystectomy,secondarily the study aims to note the post drug instillation hemodynamics,incidence and severity of postoperative nausea and vomiting |