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临床试验/CTRI/2025/09/095291
CTRI/2025/09/095291尚未招募不适用

Nalbuphine over Fentanyl as adjuvant to intrathecal Bupivacaine in Cesarean cases-Randomised Double Blind Control

DR SANCHITA ROY1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年10月7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
48
试验地点
1
主要终点
To assess whether Nalbuphine(0.8mg) causes pruritus as an intrathecal adjuvant to 0.5% hyperbaric Bupivacaine similar to Fentanyl

研究概览

简要总结

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.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Patients undergoing elective cesarean section under spinal anaesthesia.
  • Patients belonging to ASA physical status Grade I, Grade II.
  • Patients who have given informed and written consent.

排除标准

  • Patients allergic to study drug 2)Patients with any contraindication to spinal procedure 3)Failed spinal anaesthesia in patients.

结局指标

主要结局

To assess whether Nalbuphine(0.8mg) causes pruritus as an intrathecal adjuvant to 0.5% hyperbaric Bupivacaine similar to Fentanyl

时间窗: Immediately after intrathecal administration during spinal anaesthesia and then every 1 hour till 24hours from the time of administration.

次要结局

  • 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.)

研究者

发起方
DR SANCHITA ROY
申办方类型
Other [Central Hospital Maligaon, NF Railway, Guwahati, Assam, India]
责任方
Principal Investigator
主要研究者

SANCHITA ROY

Central Hospital, NF Railway, Maligaon, Guwahati

研究点 (1)

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