| CTRI Number |
CTRI/2020/10/028678 [Registered on: 28/10/2020] Trial Registered Prospectively |
| Last Modified On: |
15/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing pain relief property of bupivacaine alone and bupivacaine with dexmedetomidine when given inside abdomen after operation of gall bladder with laparoscopic method |
|
Scientific Title of Study
|
Comparative study of intraperitoneal instillation of bupivacaine alone and bupivacaine with dexmedetomidine 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 |
Vivek Vishal |
| Designation |
Primary DNB Resident |
| Affiliation |
J.L.N. Hospital and Research Centre,Sector-9,, Bhilai. |
| Address |
Department of Anesthesiology,J.L.N. Hospital and Research Centre,Sector-9, Bhilai.
Durg
CHHATTISGARH
490009
India |
| Phone |
9359271359 |
| Fax |
|
| Email |
drvivekvishal84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayita Sarkar |
| Designation |
Consultant Anaesthesia |
| Affiliation |
J.L.N. Hospital and Research Centre,Sector-9,Bhilai |
| Address |
Department of Anaesthesiology,J.L.N. Main Hospital and Research Centre,Sector-9,Bhilai
Durg
CHHATTISGARH
490009
India |
| Phone |
9407982774 |
| Fax |
|
| Email |
drjayitaonnet@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayita Sarkar |
| Designation |
Consultant Anaesthesia |
| Affiliation |
J.L.N. Hospital and Research Centre,Sector-9,Bhilai |
| Address |
Department of Anaesthesiology,J.L.N. Main Hospital and Research Centre,Sector-9,Bhilai
Korba
CHHATTISGARH
490009
India |
| Phone |
9407982774 |
| Fax |
|
| Email |
drjayitaonnet@yahoo.in |
|
|
Source of Monetary or Material Support
|
| J.L.N.Main Hospital and Research Centre,Bhilai Steel Plant, Bhilai, Chhatisgarh |
|
|
Primary Sponsor
|
| Name |
Vivek Vishal |
| Address |
Department of Anesthesiology,J.L.N. Main Hospital and Research Centre,Bhilai Steel Plant, Bhilai, Chhatisgarh |
| 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 |
| Vivek Vishal |
Department of Anesthesiology, J.L.N. Main Hospital and Research Centre |
Second floor,Main OT Complex,Department of Anaesthesia
Durg
CHHATTISGARH |
9359271359
drvivekvishal84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,All India Institute of Medical Sciences,Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intraperitoneal instillation of bupivacaine in patients undergoing laparoscopic cholecystectomy for post operative analgesia. |
At the end of surgery before removal of trocar patients will receive 40 ml of Inj.Bupivacaine 0.25% under vision into hepato-diaphragmatic space,on gall bladder bed and near and above hepatoduodenal ligament. |
| Intervention |
Intraperitoneal instillation of bupivacaine with dexmedetomidine in patients undergoing laparoscopic cholecystectomy for post operative analgesia. |
At the end of surgery before removal of trocar patients will receive 40 ml of Inj. Bupivacaine 0.25% plus Inj.Dexmedetomidine1 mcg/kg intraperitoneally under vision into hepato-diaphragmatic space,on gall bladder bed and near and above hepatoduodenal ligament. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients posted for elective laparoscopic cholecystectomy
2.ASA physical status I & II
3.BMI >18.5 & <30
|
|
| ExclusionCriteria |
| Details |
1.Patients refusal
2.Patients not satisfying above inclusion criteria
3.Allergic to study drugs
4.Pregnant or breast-feeding patient
5.Patients with cardiac,respiratory,liver and renal diseases
6.Patients with baseline heart rate<55/min.
7.Patients with AV heart blocks
8.Laparoscopic cholecystectomy converted to open cholecystectomy
9.If any other surgery,combined with laparoscopic cholecystectomy in the same sitting like incisional hernia,umbilical hernia etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Post operative pain relief using visual analogue scale(0-100mm)
2.Time to first rescue analgesic
3.24 hours post operative total analgesic requirement |
All parameters will be recorded at 0,1,2,3,4,6,8,12,18 and 24 hours in post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Haemodynamic variables(PR,MAP,SPO2)
2.Ramsay sedation score
3.Complications |
All parameters will be recorded at 0,1,2,3,4,6,8,12,18,and 24 hours in post operative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/11/2020 |
| 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
|
The primary purpose of this study is to analyse post operative analgesic efficacy both in terms of duration and degree of analgesia along with haemodynamic safety, of bupivacaine alone or in combination with dexmedetomidine when given intraperitoneally at the end of surgery in patients undergoing laparoscopic cholecystectomy.After taking informed consent patients will be allocated into either of two study groups keeping in mind blinding and patient group allocation concealment as per my protocol.Patients will be given intaperitoneal bupivacaine alone or bupivacaine with dexmedetomidine at the end of surgery before removal of trocar as per group allocation of patient.All patients will be shifted to PACU where VAS score,time to first rescue analgesic,24 hours post operative total analgesic requirement,PR,MAP,SPO2,Ramsay sedation score and any complication if any will be recorded at 0,1,2,3,4,6,8,12,18 and 24 hours in post operative period.All data will be analysed statistically. |