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临床试验/CTRI/2025/03/082969
CTRI/2025/03/082969招募中4 期

Quality of Recovery after Total Hip Replacement: A Randomised Double-Blinded Study Comparing Intrathecal Morphine and Ultrasound Guided Sacral Erector Spinae Block

AIIMS1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年3月28日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
AIIMS
入组人数
80
试验地点
1
主要终点
Quality of recovery using the QoR-15 score .

研究概览

简要总结

Hip fractures and avascular necrosis are the leading causes of hip joint replacement in India, and the incidence is multiplying. Pain following THR surgery is a significant concern, and it could be as high as 81%, as reported by previous studies, with the mean persistent post-surgical pain rate being around 16.5%. [1] Adequate analgesia with minimal side effects allows for early postoperative mobility, optimal functional recovery, and decreased postoperative morbidity [2]. Despite being a frequently performed surgical procedure, there is high variability in the peri-operative anaesthetic and analgesic management for total hip arthroplasty [3, 4].

There is strong evidence supporting the effectiveness of intrathecal morphine for pain relief after total hip arthroplasty, with no significant increase in the risk of respiratory depression with dose between 50 mcg to 100 mcg even in elderly and patients with risk of apnea.[5] The incidence of postoperative nausea and vomiting (PONV) after intrathecal morphine is dose dependent and dose less than equal to 100 µg  provide sufficient analgesia without increasing the risk of PONV. [5,6] PROSPECT guidelines for THR surgery recommend consideration of 100 mcg of intrathecal morphine administration if the procedure is being done in spinal anaesthesia. [4]

The ESPB is a regional block that targets both the dorsal and ventral roots of the spinal nerve, offering analgesia for both somatic and visceral pain. This technique facilitates the extensive distribution of local anaesthetics in a craniocaudal direction, effectively blocking multiple dermatomes. [4] Recently, some case studies suggested that the sacral erector spinae plane block (ESPB) also called as sacral multifidus block, was found to be an effective technique for providing postoperative pain relief in patients undergoing femoral fracture surgery via a posterolateral approach. [4] But this technique has not been extensively studied for adult patients undergoing hip surgeries. There is paucity of literature comparing sacral ESPB and ITM which has quality of recovery (QoR15) as the primary outcome in THR surgery. Hence, we plan to compare effect of sacral ESP block with intrathecal morphine in the quality of recovery at 24hr after THR surgery.

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 80.00 Year(s)(—)
性别
All

入选标准

  • Adults aged 18-80 years, ASA grade I, III, scheduled for elective primary total hip replacement surgery.

排除标准

  • Patients with bleeding disorders Injection site infection Vertebral column anomaly Neurological disorders Refusal to consent.

结局指标

主要结局

Quality of recovery using the QoR-15 score .

时间窗: 24 hours after the surgery.

次要结局

  • To assess the post-operative pain measured with NRS (0-10) score(at 2, 4, 12, and 24 hours after surgery.)
  • To compare time (in min) to first rescue analgesia
  • Opioid requirement during the postoperative period(24hr of surgery)
  • Incidence of PONV, Pruritus, Urinary retention(24 hr.)

研究者

发起方
AIIMS
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ananya Mishra

AIIMS, Bhubaneswar

研究点 (1)

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