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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- •Reduction in early postoperative pain scores in the oxytocin group
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 64.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 18-64 years Undergoing elective laparoscopic gynecological surgery ASA I-II Surgery duration up to 4 hours Consented to participate.
排除标准
- •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.
结局指标
主要结局
•Reduction in early postoperative pain scores in the oxytocin group
时间窗: 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.
•Lower intra-operative and post operative opioid use
时间窗: 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.
•Reduction in anxiety scores post-op
时间窗: 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.
次要结局
未报告次要终点
研究者
DR S Dharani
AIIMS MANGALAGIRI