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临床试验/CTRI/2023/01/049068
CTRI/2023/01/049068招募中4 期

A clinical comparison of intrathecal morphine versus Erector spinae plane block for postoperative pain control in patients with End Stage Kidney Disease undergoing kidney Transplantation

Mahatma gandhi hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月19日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
To evaluate and compare the effect of intrathecal morphine versus ESPB in terms of duration and quality of analgesia and post operative analgesic consumption

研究概览

简要总结

Post operative pain is a major concern after any surgery.Inadequate control of pain after major surgeries continues to be a cause ofworry since it may be associated with a delay in recovery leading to anincrease in incidence of chronic post surgical pain. At present, there arenumerous methods exist for post operative pain management after major abdominalsurgeries such as intrathecal or intravenous(I.V)opioids, epidural analgesia,and ultrasound guided peripheral nerve blocks,however options for post‑kidneytransplantation analgesia are limited due to associated comorbidities in kidneytransplant recipients.Ultrasound guided regional anaesthesia is an upcoming and rapidly progressivemethod of pain management. The ultrasound guided erector spinae plane block(ESPB) is a newer regional anaesthesia technique  currently being explored as a viable optionfor analgesia. ESPB is performed by injecting local anaesthetic in the planebetween the erector spinae muscle and transverse process. Both intrathecalmorphine and ESPB has been investigated for use in post-operative analgesia forvarious surgeries like total abdominal hysterectomy, laparoscopiccholecystectomy, percutaneous nephrolithotomy, open nephrectomy, but there arevery limited studies in regarding there use in kidney transplant recepients. With the hypothesis that both intra-thecal morphine and ultrasoundguided ESPB has effect on post operative pain management So, this study isbeing planned to compare and evaluate both modalities and observe the duration, quality of analgesia and postoperative analgesic consumption in the patients undergoing kidneytransplantation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1American Society of Anaesthesiologists (ASA) III patients 2Age group of 20-60 years 3Patient with written valid consent 4Patient undergoing renal transplant surgery.

排除标准

  • 1Patient refusal 2History of allergy to study drug 3Contraindication to spinal puncture/regional block (e.g. bleeding diathesis, neurologic dysfunction, and recent systemic or local infection); 4Insufficient comprehension to use the PCA device, 5History of drug abuse, 6Severe cardiovascular disease 7Patient with neurological disorder 8Recent use of psychoactive or analgesic medication.

结局指标

主要结局

To evaluate and compare the effect of intrathecal morphine versus ESPB in terms of duration and quality of analgesia and post operative analgesic consumption

时间窗: postoperative hours

次要结局

  • Effect on catheter related bladder discomfort(To observe any procedure and drug related complications)

研究者

发起方
Mahatma gandhi hospital
申办方类型
Private medical college

研究点 (1)

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