| CTRI Number |
CTRI/2025/09/094166 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Can a nasal spray of oxytocin help reduce pain and anxiety in women undergoing minimally invasive gynaecological surgery |
|
Scientific Title of Study
|
Efficacy of Preoperative Intranasal Oxytocin for Pain and Anxiety modulation in Women Undergoing Minimally invasive Gynecological Surgery
A Pilot Randomized Controlled Study
An Academic Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR S Dharani |
| Designation |
Junior Resident |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
Room NO: 301,
Department of OBGYN OPD,
OPD 3rd Floor,
AIIMS MANGALAGIRI Campus,
Mangalagiri,
Guntur District,
Andhra Pradesh- 522503.
Room NO: 301,
Department of OBGYN OPD,
OPD 3rd Floor,
AIIMS MANGALAGIRI Campus,
Mangalagiri,
Guntur District,
Andhra Pradesh- 522503.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9080719801 |
| Fax |
|
| Email |
m02jan025020@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Sairem Mangolnganbi Chanu |
| Designation |
Associate Professor |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
Room NO: 2079,
Second Floor,
Department of OBGYN
AIIMS MANGALAGIRI Campus,
Mangalagiri,
Guntur district,
Andhra Pradesh- 522503.
Room NO: 2079,
Second Floor,
Department of OBGYN
AIIMS MANGALAGIRI Campus,
Mangalagiri,
Guntur district,
Andhra Pradesh- 522503.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8794713545 |
| Fax |
|
| Email |
dr.mangol123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S Dharani |
| Designation |
Junior Resident |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
Room NO: 301,
Department of OBGYN OPD,
OPD 3rd Floor,
AIIMS MANGALAGIRI Campus,
Mangalagiri,
Guntur District,
Andhra Pradesh- 522503.
Room NO: 301,
Department of OBGYN OPD,
OPD 3rd Floor,
AIIMS MANGALAGIRI Campus,
Mangalagiri,
Guntur District,
Andhra Pradesh- 522503.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9080719801 |
| Fax |
|
| Email |
m02jan025020@aiimsmangalagiri.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR S DHARANI |
| Address |
ROOM NO: 301,
DEPARTMENT OF OBGYN OPD,
OPD 3RD FLOOR,
AIIMS MANGALAGIRI CAMPUS,
MANGALAGIRI,
GUNTUR DISTRICT,
ANDHRA PRADESH- 522503.
|
| 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 |
| DR S Dharani |
AIIMS MANGALAGIRI |
IPD-D3
Department of OBGYN
Guntur
ANDHRA PRADESH |
9080719801
m02jan025020@aiimsmangalagiri.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS MANGALAGIRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intranasal normal saline |
Intranasal normal saline same volume as intranasal oxytocin.
Total duration - 2 years. |
| Intervention |
Intranasal Oxytocin |
Intranasal Oxytocin 30 units, 15 units in each nostril.
Total duration - 2 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18-64 years
Undergoing elective laparoscopic gynecological surgery
ASA I-II
Surgery duration up to 4 hours
Consented to participate |
|
| ExclusionCriteria |
| Details |
Psychiatric illness or antidepressant/antipsychotic use
Nasal pathology or obstructed breathing
History of oxytocin allergy
Pregnancy or lactation
If converted to laparotomy
Women <18 years and > 64 years
|
|
|
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 |
•Reduction in early postoperative pain scores in the oxytocin group
•Lower intra-operative and post operative opioid use
•Reduction in anxiety scores post-op
|
Pain using NRS scores will be assessed at 0,2,6,12,24 hrs.
Anxiety using BAI score will be assessed preoperatively and 6 hrs postop.
Intraoperative and postoperative opioid usage. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
15/09/2025 |
| 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="2"
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
|
Title: Efficacy of
Preoperative Intranasal Oxytocin for Pain and Anxiety Modulation in Women
Undergoing Minimally Invasive
Gynaecological Surgery – A Pilot Randomized Controlled Study (An Academic Trial)
Background & Rationale:
Minimally
invasive gynaecological surgeries are associated with postoperative pain and
perioperative anxiety. Current management often requires opioids, which carry
risks. Oxytocin, a neurohormone delivered intranasally, can modulate pain and stress pathways, potentially reducing both pain and anxiety while limiting opioid need.
Objectives:
• Primary: To assess whether
intranasal oxytocin reduces
postoperative pain (Numerical Rating Scale) and anxiety (BAI scale).
• Secondary: To
assess intra- and postoperative opioid consumption.
Design & Setting:
Prospective, randomized, double-blind,
placebo-controlled pilot study at AIIMS Mangalagiri.
Participants:
72 women, aged
18–64, ASA I–II, undergoing elective minimally invasive gynaecological surgery.
Exclusions: psychiatric illness,
nasal pathology, oxytocin
allergy, pregnancy/lactation, conversion to laparotomy.
Interventions:
• Group O:
Intranasal Oxytocin 30 IU (15 IU/nostril), administered preoperatively.
• Group P: Placebo
(normal saline).
Outcome Measures:
• Pain scores (NRS:
0, 2, 6, 12, 24 hrs).
• Anxiety (BAI:
pre-op and 6 hrs post-op).
• Opioid (tramadol)
usage intra- and postoperatively.
Sample Size & Analysis:
36 per group (total 72). Based on expected 1-point
difference in NRS pain scores,
80% power, 5% significance. Intention-to-treat
analysis. Student’s t-test/Mann–Whitney U for continuous data,
Chi-square/Fisher’s
exact test for categorical data.
Expected Outcomes:
Reduction in postoperative pain and anxiety,
lower opioid requirement, safer recovery with a
non-opioid alternative.
Ethics & Administration:
IEC approval,
CTRI registration. Informed
consent mandatory. Confidentiality ensured. Self-funded
with institutional support.
Timeline:
• Protocol &
IEC approval: 2 months (mid-2025).
• Data collection:
18 months (Aug 2025 – Feb 2027).
• Analysis &
thesis writing: 3 months (Mar–Jun 2027).
• Submission: July 2027. |