跳至主要内容
临床试验/CTRI/2024/11/076182
CTRI/2024/11/076182尚未招募不适用

Dexmedetomidine as an adjuvant to lignocaine in paracervical block for daycare hysteroscopic procedures: a randomized controlled trial.

Aysha Rinsha T P1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2024年11月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
136
试验地点
1
主要终点
Effect of dexmedetomidine as an adjuvant in paracervical block on intraprocedural pain assessed by Visual Analog Scale

研究概览

简要总结

Background

Hysteroscopy, a common outpatient procedure, causes significant pain and discomfort. Effective pain management strategies are still evolving.

Current Pain Management

Several measures are used to minimize pain:

  • General anesthesia

  • Intravenous sedation

  • Inhalational anesthesia

  • Analgesics

  • Spinal anesthesia

  • Paracervical block

Paracervical Block Limitations

Studies show inconsistent pain relief with paracervical block using local anesthetics.

Dexmedetomidine Potential

Dexmedetomidine, an α2-adrenergic receptor agonist, enhances analgesic efficacy in neuraxial and peripheral nerve blocks.

Research Gap

No studies have assessed dexmedetomidine’s efficacy as an adjuvant in paracervical block for hysteroscopy.

Hypothesis

Adding dexmedetomidine to lignocaine will reduce intraoperative pain and improve patient satisfaction during diagnostic and therapeutic hysteroscopy.

This study aims to investigate the potential benefits of combining dexmedetomidine with lignocaine in paracervical block for pain management during hysteroscopic procedures.

The study will begin after obtaining approval from the PGRMC and Institute Ethics Committee.

Patient Selection:

Patients visiting the gynecology OPD for diagnostic and therapeutic hysteroscopic evaluation will be assessed for eligibility.

Preoperative Assessment:

A written informed consent will be obtained, followed by a preoperative assessment on the day of hysteroscopy, including:

  • History

  • Physical examination

  • Blood investigations

  • USG reports

Group Assignment

Patients will be randomly assigned to one of two groups:

  • Group 1: Paracervical block with lignocaine and dexmedetomidine

  • Group 2: Paracervical block with lignocaine and normal saline

Procedure

After shifting the patient to the table, ECG leads, pulse oximeter, noninvasive blood pressure cuff will be attached to the patient for monitoring. IV line will be secured for giving rescue analgesia if required. Patient will be positioned in lithotomy position and paracervical block will be given at 5 O clock and 7 O clock positions of the cervix. Hysteroscope will be inserted 5 minutes after giving paracervical block. Pain will be monitored using the Visual Analog Score (VAS)every 15 minutes from the insertion of hysteroscope until the procedure is over and then every 15 minutes for a period of two hours post procedure. Heart rate, blood pressure and SpO2 of the patient will be monitored and recorded every 5 minutes during the procedure. After the procedure is over these parameters will be monitored and recorded at every 15 minutes until 2 hours post procedure.

Pain Management

Incremental boluses of fentanyl (25 mcg) will be administered if intraprocedural VAS is > 4.If pain persists, the procedure may be abandoned and rescheduled according to the discretion of gynaecologist. Post procedural pain with VAS>4 will be managed by intravenous ketorolac 50 mg followed by intravenous tramadol 50 mg if VAS persists above 4.

Outcome Measures

  • VAS for pain

  • Duration of analgesia

  • Number of interruptions/abandonments due to pain

  • Patient satisfaction (Likert scale)

  • Incidence of nausea, vomiting, and giddiness

Management of possible adverse events:

Bradycardia (HR<60/min) will be managed using bolus of atropine (0.3mg) while bradycardia with hypotension (<80% of fall in systolic blood pressure or SBP<90 mm of Hg) will be managed with Atropine 0.6 mg iv bolus, can be repeated every 3-5 mins to a maximum dose of 3 mg.

This study’s findings will contribute to optimizing pain management strategies for hysteroscopic procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Women of age 18-65 years undergoing outpatient hysteroscopy under paracervical block.

排除标准

  • Women with following conditions: (i)Pregnancy (ii)bradycardia or heart block (iii)known cardiac disease (iv)coagulopathy (v)refusal to consent.

结局指标

主要结局

Effect of dexmedetomidine as an adjuvant in paracervical block on intraprocedural pain assessed by Visual Analog Scale

时间窗: 15 minutes interval till 2 hours after the procedures

次要结局

  • Perioperative rescue analgesic requirement(From time of insertion of hysteroscope into the uterus ,every 15 minutes until procedure is over and after the procedure for a period of 2 hours)
  • Patient satisfaction measured using Likert Scale(Two hours after the hysteroscopy)
  • Incidence of premature termination and interruption of procedure due to pain(After the insertion of hysteroscope into the uterus until hysteroscopy is completed)
  • Incidence of nausea, vomiting and giddiness.(From the time of giving paracervical block until two hours after the hysteroscopic procedure)
  • Duration of analgesia(From time of completion of paracervical block to request of first rescue analgesic.)

研究者

发起方
Aysha Rinsha T P
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Aysha Rinsha T P

Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry.

研究点 (1)

Loading locations...

相似试验