| CTRI Number |
CTRI/2022/05/042755 [Registered on: 23/05/2022] Trial Registered Prospectively |
| Last Modified On: |
21/05/2022 |
| 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
|
Comparison of drugs used for prolonging pain control under spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of post-operative Analgesic properties of Intrathecal Buprenorphine versus Midazolam as an Adjuvvant to 0.5% Hyperbaric Bupivacaine in Lower abdominal surgeries : A Randomized Double Blind interventional Controlled Study at SMS Medical College & attached Group of Hospitals, Jaipur during 2021-2023 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandan Bala Mali |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anesthesia, Sawai Man Singh Medical College,Ram Singh Road , Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9468661920 |
| Fax |
|
| Email |
chandanbalamali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samridhi Nanda |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anesthesia, Sawai Man Singh Medical College,Ram Singh Road , Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9680565399 |
| Fax |
|
| Email |
samridhinanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samridhi Nanda |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anesthesia, Sawai Man Singh Medical College,Ram Singh Road , Jaipur
Dausa
RAJASTHAN
302004
India |
| Phone |
9680565399 |
| Fax |
|
| Email |
samridhinanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology SMS Medical College Jaipur |
|
|
Primary Sponsor
|
| Name |
SMS Hospital |
| Address |
Department of Anesthesia, Sawai Man Singh Medical College,Ram Singh Road , Jaipur Rajasthan
302004 |
| 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 |
| dr samridhi nanda |
SMS Hospital |
Orthopaedic OT,second floor,Department of Anaesthesia, Dhanwantari Building
Jaipur
RAJASTHAN |
9680565399
samridhinanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, Sawai Man Singh Medical College |
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 |
| Intervention |
Intrathecal Buprenoprphine |
Group B- 4ml of a mixture containing 3ml of 0.5% hyperbaric Bupivacaine and 1 ml of Buprenorphine (60 mcg) for 60-90 mins |
| Intervention |
Intrathecal Midazolam |
Group C- 4 ml of mixture containing 3ml of 0.5% hyperbaric Bupivacaine and 1 ml of midazolam (2 mg) for 60-90 mins |
| Comparator Agent |
Intrathecal Normal Saline |
Group A- 4 ml of a mixture containing 3ml of 0.5% and 1 ml of Normal Saline for 60-90 min |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of either sex
2 Age group between 25 and 55 years
3 ASA grade I & II
4 Body weight 45 to 65 kg
5 Undergoing lower abdominal surgeries like Ovarian cystectomy, herniorraphy, abdominal hysterectomy. (Duration 60-90 min)
|
|
| ExclusionCriteria |
| Details |
1 Patients not willing to participate in the study
2 Cases with sepsis, bacteremia or skin infection of local site
3 History of severe hypovolemia, anemia and compromised renal, cardiac or respiratory status
4 Cases with raised intracranial tension
5 History of blood coagulopathies
6 Patient allergic to drugs used for study
7 Uncooperative patients
8 Failure of spinal anesthesia, cases in which general anaesthesia will be required
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean time duration for the need of first rescue analgesia |
At end of surgery then post-op 30 min ,60min 90min,120min,150min,180min,210min 4hr,6hr,8hr,12hr,24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To assess and compare the onset time and duration of Sensory and Motor block.
• To assess and compare Hemodynamic parameters: (Heart Rate; Mean Blood Pressure; Systolic Blood Pressure; Diastolic Blood Pressure), Sedation score and VAS score.
• To find out and compare the proportion of cases with complications.
|
At start of surgery then 5min,10min,15min,20min,25min,30min,40min,50min,60min,70min,80min,90min then end of surgery then post-op 30 min ,60min 90min,120min,150min,180min,210min 4hr,6hr,8hr,12hr,24hr |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/06/2022 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published so far |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Many adjuvants are used to increase the duration of postoperative analgesia , however little literature is available for adjuvants like buprenorphie and Midazolam . We hypothesize that these agents when added to intrathecal Bupivacaine 0.5% would prolong the duration of postoperative analgesia. |