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临床试验/CTRI/2024/11/076544
CTRI/2024/11/076544尚未招募不适用

Comparison between pericapsular nerve group block and suprainguinal fascia iliaca block for perioperative pain control in hip arthroplasty: A randomized controlled trial

AL AZHAR MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年12月1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
66
试验地点
1
主要终点
.post block NRS at rest and on passive 15° limb lifting

研究概览

简要总结

Pain associated with hip surgery -a significant problem-Complications, morbidities, and low levels of patient satisfaction.Two blocks that have recently become popular for hip analgesia include pericapsular nerve group (PENG) block and SIFI block.There is paucity in literature regarding these blocks and to which one is more efficacious.

We hypothesised that SIFI block would provide better analgesia without significant quadriceps muscle weakness when compared with the PENG block following THA.

The study will be carried out in accordance with the ethical principles of the Declaration of Helsinki, 2013. Its procedure will be explained to each patient, and a written and informed consent will be taken for participation in this study and for the use of the patient data for educational and research purposes. The consultant doing the pre-anaesthetic check-up will carry out a consecutive sampling of all eligible participants and enroll them into the study. Randomisation will be done by an independent statistician using software for block randomisation techniques of varying block sizes (3–5). Allocation concealment will be done using serially numbered, opaque, sealed envelopes (SNOSE technique). The sealed envelope will be opened by a consultant who is not part of the study once the patient  reaches the pre-medication room, thus assigning the participant to the intervention. This assigned consultant then performs the block in the block room. All observations will be done in the operating room and PACU  by the investigator  who is unaware of the regional block performed.  All the participants will remain blinded to the block administered.

NRS score will be explained to the patients at the time of pre-operative assessment.Pre-procedure pain will be  assessed during rest as well as on movement (15° passive elevation) of the affected limb and recorded on numeric pain rating scale (NRS) [0 = no pain; 10 = worst imaginable pain].

The blocks will be performed in supine position following sterile techniques. Both the blocks will be performed as per the standard USguided techniques using 30 ml 0.2 % ropivacaine with 4mg dexamethasone.

After the block, patient  will be shifted to the operating room and will be continuously monitored with non-invasive blood pressure every 5 minutes, continuous ECG and pulse oximetry and for signs of local anaesthetic toxicity for 30 minutes. Thirty minutes after the blocks, analgesia will be measured by NRS at rest and on passive limb elevation. If any patient had NRS >5, intravenous (IV) fentanyl 20 µg will be given every 5 minutes till NRS score becomes 3, and then, they will be allowed for sitting position for SA.NRS score will be explained to the patients at the time of pre-operative assessment.Pre-procedure pain will be  assessed during rest as well as on movement (15° passive elevation) of the affected limb and recorded on numeric pain rating scale (NRS) [0 = no pain; 10 = worst imaginable pain].

The blocks will be performed in supine position following sterile techniques. Both the blocks will be performed as per the standard USguided techniques using 30 ml 0.2 % ropivacaine with 4mg dexamethasone.

After the block, patient  will be shifted to the operating room and will be continuously monitored with non-invasive blood pressure every 5 minutes, continuous ECG and pulse oximetry and for signs of local anaesthetic toxicity for 30 minutes. Thirty minutes after the blocks, analgesia will be measured by NRS at rest and on passive limb elevation. If any patient had NRS >5, intravenous (IV) fentanyl 20 µg will be given every 5 minutes till NRS score becomes 3, and then, they will be allowed for sitting position for SA.

The amount of fentanyl used, NRS scores and scores for EOSP will be recorded.

All observations will be done by another anaesthesiologist who is unaware of the regional block performed. All patients will receive spinal anesthesia with 10mg of hyperbaric bupivacaine (ie, 2mL of bupivacaine 0.5%) and 20µg of fentanyl.All interventions will be performed by the same team of surgeons using a posterior approach and a lateral decubitus position.

Postoperative analgesia will be  provided with IV paracetamol 1 gm every 8 h. The rescue analgesia will be provided with 1 mg morphine on demand or when NRS is >4.All patients will be followed up postoperatively at 2,4, 6, 8, 12 and 24 hours.

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
25.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA physical status 1-3 patients 2.Age 25-80yrs 3.Scheduled for primary hip arthroplasty under spinal anaesthesia.

排除标准

  • 1.Surgeries under GA 2.Patients who refused to give consent 3.Those with focal neurological deficit 4.History of allergy to local anaesthetic 5.Infection at the puncture site 6.Unable to understand NRS • Coagulopathy/sepsis/hepatic or renal failure • prior surgery of the inguinal or suprainguinal area.

结局指标

主要结局

.post block NRS at rest and on passive 15° limb lifting

时间窗: 30 minutes after the block

.Ease of spinal positioning

时间窗: 30 minutes after the block

.postoperative morphine requirement

时间窗: 30 minutes after the block

次要结局

  • . NRS over 24 hours(.amount of morphine used (number of rescue doses))

研究者

发起方
AL AZHAR MEDICAL COLLEGE
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

ANNU JOSE

AL AZHAR MEDICAL COLLEGE

研究点 (1)

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