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临床试验/CTRI/2024/03/064754
CTRI/2024/03/064754尚未招募2 期

Comparison Of Ultrasound-guided Pecto-Intercostal Fascial Plane block and Serratus Anterior Plane block in managing post-sternotomy pain after cardiac surgery: A Randomised Controlled Trial

Bharati Vidyapeeth (Deemed to be) University Medical College, Pune1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
To compare the efficacy of postoperative analgesia with Pecto-intercostal fascial plane block and Serratus Anterior Plane block.

研究概览

简要总结

Postoperative pain following sternotomy is a common occurrence in cardiac surgery, often attributed to factors like rib fractures, or intercostal nerves resulting from prolonged sternal retraction and surgical incisions. Although the intensity of acute post-sternotomy pain peaks on the first day after surgery, it can persist upto a week. In cardiothoracic surgery, regional anaesthesia is frequently integrated into multimodal analgesic strategies to mitigate acute post sternotomy pain. This approach, especially in the context of Enhanced Recovery has gained popularity for its potential to reduce opioid usage and associated side effects. Pain generated from a sternotomy incision is complex and has been attributed to various pain-generators. The quest for an ideal analgesia technique continues despite various advances in multimodal analgesia. In this study we aim to compare a novel technique of Pecto-Intercostal Fascial Plane (PIFP)  block with the well-established Serratus Anterior Plane (SAP) block. Pecto-intercostal fascial plane block is a superficial block as compared to serratus anterior plane block and can be performed in the supine position.

AIM:

 To compare the efficacy of ultrasound guided bilateral Pecto-intercostal fascial plane (PIFP) block and Serratus anterior plane (SAP) block in managing acute post sternotomy pain in patients undergoing elective cardiac surgery with midline sternotomy.

 OBJECTIVES:

 Primary:

To compare the efficacy of postoperative analgesia with  PIFP and SAP.

 Secondary:

To compare PIFP & SAP with respect to:

Performance of incentive spirometry

Total analgesic requirement in first 24 hours post-extubation.

  1. During the pre-anaesthesia visit, informed, valid consent will be taken from the study population, in the language best understood by them and after explaining them the study in detail. They will be also explained the visual analogue scale that will be used for assessment of postoperative analgesia.

  2. Patients will be randomly allocated to one of the two groups based on a 1:1 randomization ratio (Group A or Group B) using opaque sealed envelopes one hour before surgery. Randomization will be performed using a computer-generated random number list (Microsoft Office 365 Excel, Microsoft, Redmond, WA).

3.  Each patient will be asked to choose an envelope containing the name of a group, which is numbered according to randomization, to which the patients subsequently were assigned.

4.  All patients, outcome assessors (anesthesia residents and nursing staff), and surgeons will be blinded to the group assignments. An anaesthesiologist with expertise in regional anesthesia will perform the blocks to ensure the quality and consistency.

  1. The PIFP and SAP blocks will be administered after completion of cardiac surgery before final dressing of suture wound. The standard monitoring of ECG, oxygen saturation and intra-arterial blood pressure will be continued till the completion of the block.

  2. PIFP and SAP block will be performed under all aseptic precautions and under ultrasound guidance using the high-frequency linear ultrasound probe (13-6 MHz).

7.    After successful and satisfactory administration of either of the blocks, the patient will be shifted to cardiac recovery ICU. The time of block completion will be noted.

8.    All patients will receive Inj Paracetamol 1gm i.v. 8 hourly.

9.    The time to extubation will be defined as the time elapsed from the completion of block to the time of extubation of the trachea.

10.The postoperative pain will be assessed using the visual analogue scale (VAS)  at extubation, every 2 hours thereafter for first 8 hours post-extubation, and every 4 hourly thereafter till 24 hours post-extubation.

11.If VAS >3, patients will be administered Inj. Fentanyl 0.5-1 mcg/kg intravenously as rescue analgesic.

12.The duration of postoperative analgesia will be defined as the duration from the completion of the block to the first dose of rescue analgesic administered to the patient.

13.The total analgesic consumption over 24 hours postextubation will be compared in both the groups.

14.VAS will be assessed during incentive spirometry.

15.The performance of incentive spirometry will be assessed and compared in both groups (no of balls lifted during incentive spirometry).

研究设计

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

入排标准

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

入选标准

  • Patients of ASA physical status III, in the age group of 18-60 years, posted for elective cardiac surgeries with midline sternotomy, under general anaesthesia.

排除标准

  • Patients with delayed extubation (more than 6 hours postoperatively) Patients with altered mental status or psychiatric illness patients with infection or trauma at the site of block.

结局指标

主要结局

To compare the efficacy of postoperative analgesia with Pecto-intercostal fascial plane block and Serratus Anterior Plane block.

时间窗: Postextubation time to request of analgesic or VAS (Visual Analog Scale) more than 3, will be assessed at extubation and post-extubation at 2hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 20 hours and 24 hours.

次要结局

  • To compare performance of Incentive spirometry.(Immediately after extubation, at 6 hours & 12 hours after extubation)
  • Total analgesic requirement in first 24 hours post-extubation(First 24 hours from extubation.)

研究者

发起方
Bharati Vidyapeeth (Deemed to be) University Medical College, Pune
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Kaushal Kenchey

Bharati Vidyapeeth (Deemed to be) University Medical College

研究点 (1)

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