| CTRI Number |
CTRI/2019/08/020674 [Registered on: 13/08/2019] Trial Registered Prospectively |
| Last Modified On: |
09/08/2019 |
| 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
|
Infiltration of an adjuvant drug with local anaesthetic for post operative pain relief in lower abdominal surgries |
|
Scientific Title of Study
|
Post operative analgesic efficacy of dexmedetomidine with bupivacaine in wound infiltration for lower abdominal surgries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mona VASUDEV BILANDANI MONA VASUDEV |
| Designation |
second year resident doctor anaesthesiology |
| Affiliation |
B.J. Medical College |
| Address |
PG Hostel,phase 1,room no-E302,civil hospital campus,Asarwa.Ahmedabad
A/16 Sannidhya Duplex near sai chowkdi towards ambe school manjalpur vadodara 390011
Vadodara
GUJARAT
390011
India |
| Phone |
9408353053 |
| Fax |
|
| Email |
bilandanim@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Patel |
| Designation |
asst. professor |
| Affiliation |
B.J. Medical College |
| Address |
Dept. of Anaestheso;ogy, B.J. Medical College,Civil Hospital,Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9428804290 |
| Fax |
|
| Email |
kiru4576@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Patel |
| Designation |
asst. professor |
| Affiliation |
B.J. Medical College |
| Address |
Dept. of Anaestheso;ogy, B.J. Medical College,Civil Hospital,Ahmedabad
GUJARAT
380016
India |
| Phone |
9428804290 |
| Fax |
|
| Email |
kiru4576@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Health and Family Welfare Department.Government of Gujarat ,7th Floor,7th Block,New Sachivalay,Gandhinagar |
|
|
Primary Sponsor
|
| Name |
Department of Health and Family Welfare |
| Address |
7th Floor,7th Block,New Sachivalay,Gandhinagar |
| Type of Sponsor |
Government 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 |
| Mona Bilandani |
Civil hospital Bj medical college ahmdabad |
F-3 Wing, General surgery department
Ahmadabad
GUJARAT |
9408353053
bilandanim@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee,b.j. medical college & civil hospital,ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
bupivacaine plain with two comparative doses of dexmedetomidine |
comparison in terms of onset of action and duration of analgesia and post operative sedation after wound infiltration
Group BDI bupivacaine 0.25% + 0.5 mg/kg total 20 cc
Group BDII bupivacaine 0.25% + 1 mg/kg total 20 cc
To be infiltrated in the wound infiltration before wound closure via 23 G hypodermic needle
And post operative analgesic effect of the given drup will b studied and postoperative side effects, if any , will be observed for 24 hours of postoperative period.
|
| Intervention |
wound infiltration |
Group B dose bupivacaine 0.25% + 2 cc ns total 20 cc
To be infiltrated in the wound infiltration before wound closure via 23 G hypodermic needle
And post operative analgesic effect
of the given drup will b studied and postoperative side effects, if any , will be observed for 24 hours of postoperative period.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I & II
SCHEDULED FOR LOWER ABDOMINAL SURGERIES |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients with H/o cardiac, respiratory, renal or hepatic dysfunction or failure
Coagulation disorders
Psychological disorders
Allergy to study medications
Chronic use of pain medications
Adrenoreceptors agonists or antagonists
Patients with H/o Motion sickness
Patient with Body mass index > 35
Women who are in menstruation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration and efficiency of post operative analgesia after wound infiltration |
duration of post operative analgesia 48 hour after wound infiltration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The effectiveness and onset of post operative analgesia,sedation and complications if any. |
48 hour post operative period |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
31/08/2019 |
| 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="0"
Months="10"
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)?
|
|
Brief Summary
|
This is a prospective randomized study for post operative analgesic efficacy of wound infiltration of bupivacaine alone and with combinations of two comparative doses of dexmedetomidine.The post operative analgesia upto 48hours post operative period is observed and also the time for first rescue analgesia ( inj tramadol in our study) is observed. 75 study patients divided randomly into 3 groups (25 in each group) Group
B = Inj.
Bupivacaine Hydrochloride 0.25% 18 ml + Placebo (Normal Saline 0.9%) 2 ml 0.9%
NS
Group
BD(I)= Inj. Bupivacaine Hydrochloride 0.25% 18 ml + Inj.
Dexmetedomine 0.5 mcg/kg 2 ml 0.9% NS
Group
BD(II)= Inj. Bupivacaine Hydrochloride 0.25% 18 ml + Inj.
Dexmetedomine 1 mcg/kg 2 ml 0.9% NS Ø The
hypothesis of our study is that dexmedetomedine when added as an adjuvant to
bupivacaine in wound infiltration in lower abdominal surgries, potentiates
action of bupivacaine and duration of post operative pain relief will be longer
as compared to bupivacaine alone. |