| CTRI Number |
CTRI/2023/12/060886 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
21/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study for the comperison of pain-free duration after administration of inj.butorphenal vs inj.fentanyl with inj.levobupivacaine epidurally in patients undergoing vaginal hysterectomy |
|
Scientific Title of Study
|
A comparision of epidural butorphanol and fentanyl as an adjuvant with 0.5%levobupivacaine for postoperative analgesia in patients undergoing vaginal hysterectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrARVIND KHARE |
| Designation |
Senior professor |
| Affiliation |
Jawahar lal neharu medical college |
| Address |
department of anaesthesiology, new OT, 1st floor JLN medical hospital kalabagh, Ajmer Rajastan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrARVIND KHARE |
| Designation |
Senior professor |
| Affiliation |
Jawahar lal neharu medical college |
| Address |
Department of anaesthesiology, new OT, 1st floor JLN hospital kalabagh, Ajmer Rajastan
RAJASTHAN
305001
India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrARVIND KHARE |
| Designation |
Senior professor |
| Affiliation |
Jawahar lal neharu medical college |
| Address |
Department of anaesthesiology new OT 1st floor JLN hospital kalabagh, Ajmer Rajastan
RAJASTHAN
305001
India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology JLN medical college and hospitals, Kalabhag road, Ajmer Rajastan 305001 |
|
|
Primary Sponsor
|
| Name |
JLN medical college |
| Address |
kalabagh Ajmer rajastan |
| 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 |
| DrKavya L |
JLN medical college and hospital |
department of anaesthesiology, new OT 1st floor JLN hospital kalabagh
Ajmer
RAJASTHAN |
9916482226
lkavya11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee Jawaharlal nehru medical college and hospitals ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N819||Female genital prolapse, unspecified, (2) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inj.butorphenal 2mg
inj.Fentanyl 50 mcg
|
with due approval from institutional ethical committee , a prospective randomized double blinded study has been planned on 80 adult female patients who will be undergoing vaginal hysterectomy under epidural anaesthesia. participants will be allotted into group LB receiving inj.butorphenal and group LF receiving inj.fentanyl as an adjuvant with local anaesthetic in above mentioned dose as single injection. will be compared for duration of analgesia, monitored till patient complains of pain in postoperative period. a written informed consent will be taken from participants prior the procedure |
| Intervention |
inj.Butorphenal 2mg
inj.Fentanyl 50 mcg
|
with due approval from institutional ethical committee, a prospective randomized double blinded study has been planned on adult female patients who will be undergoing vaginal hysterectomy under epidural anaesthesia. participants will be allocated in to Group LB receiving Inj. butorphanal and group LF receiving inj.fentanyl as an adjuvant with inj.levobupvacaine 0.5% epidurally at dose as mentioned above as single time administration. will be compared for duration of analgesia, monitored till they complain of pain during postoperative period. a written informed consent will be taken from all the participants prior the procedure. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 and 2
female undergoing vaginal hysterectomy
|
|
| ExclusionCriteria |
| Details |
ASA >2
comorbidities
pregnant patients
breastfeeding
local infection
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
assessment of visual analogue score for pain in postoperative period at immediately after shifting post operative unit,after 1hr,2hr,3hr,4hr, 6hr,8hr,10hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
onset & duration of sensory block
onset duration of motor block |
assessment of sensory block using pinprick sensation assessed
assessment of motor block by modified bromage scor at baseline,5minutes,10minutes,15minutes,30minutes,1hr,2hr,3hr,4hr,6hr,8hr & postoperative period hourly interwal |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
04/01/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This will be a double blinded randomized study conducted to evaluate inj. Butorphenal 2mg and inj. fentanyl 50 mcg as an adjuvant with inj.levobupivacaine 0.5% 15ml epidurally in patients who are between 30 to 70yr old, ASA grade 1 or 2 with excemption of all exclusion criteria mentioned above and undergoing vaginal hysterectomy under epidural analgesia with primary objective of comparing the duration of analgesia. seconadry objectives being onset and duration of sensory block, onset and duration of motor block, cardiovascular effects, side effects . participants will be allocated in to 2 groups each with 40 sample size . Group LB receiving inj.butorphenal group LF receiving inj.fentanyl as an adjuvant with local anaesthetic epidurally in above mentioned dosagey. pre anaesthetic evaluation will be done previous day , necessary premedication will be given , informed written consent will be taken prior to surgery. all emergency drugs and equipments will be kept ready in prior. under all aseptic precautions respective drugs will be given epidurally to respective group of patient. patient will be monitored intraoperative and postoperatively. all the parameters will be recorded at pre described interval and documented. data will be analyses statistically using standard qualitative and quantitative tests. continuous variables will be analyzed using student paired test and chategorical variables will be analyzed using chi-square test. P value of less than 0.05 will be considered significant. |