| CTRI Number |
CTRI/2025/09/095291 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Nalbuphine over Fentanyl as adjuvant to Bupivacaine during spinal anaesthesia in Cesarean cases |
|
Scientific Title of Study
|
Nalbuphine over Fentanyl as adjuvant to intrathecal Bupivacaine in Cesarean cases-Randomised Double Blind Control |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANCHITA ROY |
| Designation |
Post Graduate Student, DNB |
| Affiliation |
Central Hospital, NF Railway, Maligaon, Guwahati |
| Address |
Room No 2, Post Graduate Doctors Hostel, Central Hospital, NF Railway, Maligaon, Guwahati
Assam
781011
India
Room No 2, Post Graduate Doctors Hostel, Central Hospital, NF Railway, Maligaon, Guwahati
Assam
781011
India
Kamrup
ASSAM
781011
India |
| Phone |
8811856301 |
| Fax |
|
| Email |
dr.sanchita28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANIRUDHA DEWRI |
| Designation |
Senior Consultant Anaesthesiology ,Central Hospital Maligaon ,N F Railway |
| Affiliation |
Senior Consutant Anaesthesiology ,Central Hospital Maligaon ,N F Railway |
| Address |
Office Of The Medical Director, Central Hospital Maligaon, NF Railway,Guwahati, Kamrup Metro
Assam India
Office Of The Medical Director, Central Hospital Maligaon, NF Railway, Guwahati Kamrup Metro
Assam India
781011
INDIA
Kamrup
ASSAM
781011
India |
| Phone |
9957550517 |
| Fax |
|
| Email |
dranirudha85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SANCHITA ROY |
| Designation |
Post Graduate Student, DNB |
| Affiliation |
Central Hospital, NF Railway, Maligaon, Guwahati |
| Address |
Room No 2, Post Graduate Doctors Hostel, Central Hospital, NF Railway, Maligaon, Guwahati
Assam
781011
INDIA
Room No 2, Post Graduate Doctors Hostel, Central Hospital, NF Railway, Maligaon, Guwahati
Assam
781011
INDIA
Kamrup
ASSAM
781011
India |
| Phone |
8811856301 |
| Fax |
|
| Email |
dr.sanchita28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Hospital, NF Railway, Maligaon, Guwahati, Assam, India, Pin-781011 |
|
|
Primary Sponsor
|
| Name |
DR SANCHITA ROY |
| Address |
Central Hospital, NF Railway, Maligaon, Guwahati, Assam, India, Pin-781011
781011
ASSAM |
| Type of Sponsor |
Other [Central Hospital Maligaon, NF Railway, Guwahati, Assam, India] |
|
|
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 SANCHITA ROY |
Central Hospital Maligaon, NF Railway |
Central Hospital, NF Railway,PNGB ROAD, Maligaon, Guwahati, Assam, India
781011
Assam
India
Kamrup
ASSAM |
8811856301
dr.sanchita28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Gauhati Medical College & Hospital, Guwahati- 781032, Assam, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O997||Diseases of the skin and subcutaneous tissue complicating pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O997||Diseases of the skin and subcutaneous tissue complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FENTANYL 10mcg |
Fentanyl(10mcg) single dose is used as an adjuvant to Bupivacaine(0.5%) in spinal anaesthesia intrathecal route of administration during the intervention performed and its effects are observed every hour from its time of intervention till 24 hours. |
| Intervention |
NALBUPHINE 0.8mg
|
Nalbuphine (0.8mg)single dose is used as an adjuvant to Bupivacaine(0.5%) in spinal anaesthesia intrathecal route of administration during the intervention performed and its effects are observed every hour from its time of intervention till 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1)Patients undergoing elective cesarean section under spinal anaesthesia.
2)Patients belonging to ASA physical status Grade I, Grade II.
3)Patients who have given informed and written consent. |
|
| ExclusionCriteria |
| Details |
1)Patients allergic to study drug
2)Patients with any contraindication to spinal procedure
3)Failed spinal anaesthesia in patients
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess whether Nalbuphine(0.8mg) causes pruritus as an intrathecal adjuvant to 0.5% hyperbaric Bupivacaine similar to Fentanyl |
Immediately after intrathecal administration during spinal anaesthesia and then every 1 hour till 24hours from the time of administration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the sensory & motor block characteristics & duration of post operative analgesia of Nalbuphine & Fentanyl as intrathecal adjuvants to 0.5% hyperbaric Bupivacaine. |
Immediately after intrathecal administration of spinal anaesthesia, 5, 10 minutes to look for onset of sensory & motor block.
1 hour, 2 hours, 3 hours, 6hours, 12hours to look for duration of sensory & motor block & for duration of post operative analgesia. |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
07/10/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.sanchita28@gmail.com].
- For how long will this data be available start date provided 30-10-2025 and end date provided 30-12-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Spinal anaesthesia is the most popular and common regional technique for lower abdominal and lower limb surgeries. Opioids are one among such adjuvants having synergistic action with local anaesthetics and intensify the sensory blockade.
Fentanyl is a lipophilic opioid and mu receptor agonist, which on intrathecal injection has rapod onset, improves quality of anaesthesia, post operative analgesia, haemodynamic stability. It is a commonly used opioid adjuvant with intrathecal bupivacaine. However, the addition of intrathecal Fentanyl was associated with higher incidence of pruritus. However, small doses of Fentanyl(5-10mcg) are as effective as larger doses and may produce less itching.
Nalbuphine, a non-scheduled Kappa opioid receptor agonist and mu opioid receptor antagonist, has been in clinical use for post operative pain management and recently has been in clinical trials for chronic itch. Few studies have shown that intrathecal nalbuphine improves quality of block and provides significant post operative analgesia when added as an adjuvant to bupivacaine with minimal side effects.
Pruritus occurs as an unwanted and troublesome side effect of intrathecally administered opioids. It is bothersome to the patient and sometimes may be more unpleasant than pain itself for the patient. Also, parturients are more susceptible to neuraxial opioid induced pruritus. The treatment of intrathecal opioid induced pruritus also remains a challenge.
This study evaluates and compares the characteristics of spinal block and its effects in adult patients undergoing elective lower abdominal and lower limb surgeries who either received a subarachnoid block with Bupivacaine along with either Fentanyl/ Nalbuphine as adjuvant. |