| CTRI Number |
CTRI/2023/08/056742 [Registered on: 22/08/2023] Trial Registered Prospectively |
| Last Modified On: |
10/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two drugs nalbuphine and fentanyl as an additive to 0.5% hyperbaric bupivacaine in lower abdominal surgeries |
|
Scientific Title of Study
|
A prospective randomized comparative study of intrathecal Nalbuphine vs Fentanyl as an adjuvant to 0.5% Hyperbaric Bupivacaine in below umbilical surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sri Priyadharshini B R |
| Designation |
Post graduate |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Room number 107
Department of Anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam, Madagadipet,Puducherry – 605107
Room number 107
Department of Anaesthesiology Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam, Madagadipet,Puducherry – 605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9500288659 |
| Fax |
|
| Email |
dr.priyaraj1205@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suneeth P Lazaurus |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Room number 109
Department of anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam, Madagadipet,Puducherry – 605107
Room number 109
Department of anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam, Madagadipet,Puducherry – 605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9500288659 |
| Fax |
|
| Email |
lazarus.suneeth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sri Priyadharshini B R |
| Designation |
Postgraduate |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Room number - 107
Department of anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam, Madagadipet,Puducherry – 605107
Room number - 107
Department of anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam, Madagadipet,Puducherry – 605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9500288659 |
| Fax |
|
| Email |
dr.priyaraj1205@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula vinayagar Medical College and hospital |
|
|
Primary Sponsor
|
| Name |
SRI PRIYADHARSHINI BR |
| Address |
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam, Madagadipet,Puducherry 605107 |
| 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 |
| Sri Priyadharshini B R |
Sri Manakula Vinayagar Medical College and Hospital |
Room number 107
Department of anaesthesiology
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthal kuppam, Madagadipet,Puducherry 605 107
Pondicherry
PONDICHERRY |
9500288659
dr.priyaraj1205@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Manakula Vinayagar Medical College and Hospital Ethics Committee |
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 |
Atropine,Ephedrine |
To assess and compare the duration of post operative analgesia of Nalbuphine(1mg) and Fentanyl(25mcg) as an adjuvant to 0.5 % Hyperbaric bupivacaine as spinal anesthesia in infra-umbilical surgeries. |
| Comparator Agent |
Nalbuphine vs Fentanyl |
To assess and compare the duration of post operative analgesia of Nalbuphine(1mg) and Fentanyl(25mcg) as an adjuvant to 0.5 % Hyperbaric bupivacaine as intrathecal anesthesia in infra-umbilical surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients posted for elective infra-umbilical surgerY under ASA physical status 1 & 2.
|
|
| ExclusionCriteria |
| Details |
1. Body Mass Index >30.
2. Patients with local site infection, allergy to the drugs that are tested or any other contraindications for spinal anesthesia.
3. Patients who cannot lie down/ non co-operative/ psychiatric illness.
4. Alcoholics.
5. Pregnant / Lactating women.
6. Patient having failed spinal, transformed into general anesthesia will be excluded from study.
7. Patients refusal for participation in the study.
8. Patients with height less than 150 cm.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the duration of post operative analgesia of Nalbuphine and Fentanyl as an adjuvant to 0.5 % Hyperbaric bupivacaine as intrathecal anesthesia in infra-umbilical surgeries. |
Duration of post operative analgesia assessed for every 30 minutes for 4hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare the onset and duration of sensory blockade and motor blockade.
To assess and compare the hemodynamic parameters.
To observe and compare the incidence of adverse events.
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3 |
|
Date of First Enrollment (India)
|
25/08/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients posted for infra umbilical elective
surgeries under spinal anesthesia.Participants will be selected as per the inclusion and exclusion
criteria and consecutively enrolled into the study till the targeted sample
size is achieved. Randomization will be
done to allocate the participants into the two groups. Block randomization will
be done with the help of external person not involved in the study
(epidemiology unit of community medicine department).The proposed study will be a double blinded
randomized study. The nalbuphine 1mg or fentanyl (25mcg) as an adjuvant along
with 0.5%hyperbaric bupivacaine will be given to the patient by an
anesthesiologist who is not involved in thestudy via intrathecal route. He/ She
will administer the drug intrathecally according to the code received by the
patient. The investigator who records the data will not be aware of the
participant’s group. The participant will not know to which group he/she is
being allotted. Sequence will be handed over to the principal investigator in
sealed envelope. Decoding will be done by the statistician. |