ESPB Versus PVPB Regarding Their Effect on Peri-operative Opioid Consumption in Patients Undergoing Minimally Invasive Mitral Valve Replacement

Not Applicable

Completed

• Conditions: ERAS; Post Operative Pain
• Interventions: Procedure: Thoracic paravertebral plane block; Procedure: Thoracic erector spinae plane block

• Registration Number: NCT05884164
• Lead Sponsor: Ain Shams University

Brief Summary

In recent years , the popularity of ultrasound-guided fascial plane blocks has increased in achieving an effective postoperative analgesia and hence achieving enhanced recovery after surgery (ERAS) .

Mastering the use of ultrasound encourages anesthetists on the frequent use of regional anesthesia . Fascial plane blocks are increasingly becoming a part of multimodal analgesia as an alternative pain management strategy in cardiac surgery. Various regional techniques especially paravertebral plane blocks have been recently described to reduce the postoperative pain in cardiac surgery with enhanced recovery . Ultrasound-guided erector spinae plane block is a recently introduced technique for regional analgesia in thoracic neuropathic pain, rib fractures, and breast surgeries. This study aims to compare between the two techniques regarding their peri-operative analgesic effect and their impact on enhanced recovery after surgery.

Detailed Description

This study aims to compare between the effectiveness of Erector spinae plane block and thoracic paravertebral plane block in reducing the perioperative need of opioids in patients undergoing minimally invasive mitral valve replacement as part of ERAS.

Study Timeline

• Study Start: 2022-03-24
• Study First Submitted: 2023-04-01
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-06-01
• Primary Completion: 2024-10-07
• Study Completion: 2025-03-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-26
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients with American Society of Anesthesiologists (ASA) score III.
• Patients aged ≥ 18 years old.
• Patients scheduled for minimally invasive mitral valve replacement through a right mini thoracotomy.

Exclusion Criteria

• Patients refusing to be involved in this study.
• Patients with ASA score > III.
• Patients aged < 18 years.
• Patients with local infection at the site of needle puncture.
• Patients with known hypersensitivity to local anesthetic (LA).
• Patients with hepatic or renal impairment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paravertebral block group	Thoracic paravertebral plane block	Patients will receive paravertebral plane block after general anaesthesia .
Erector spinae group	Thoracic erector spinae plane block	Patients will receive erector spinae plane block after general anaesthesia .

Primary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	For 24 hours after extubation	morphine in milligram postoperatively
intraoperative opioid consumption	Through intraoperative period, average of 6 hours	Fentanyl in micrograms intraoperatively

Secondary Outcome Measures

Name	Time	Method
Time for extubation	24 hours postoperative	The time it took for the patient to be extubated in ICU
Time for ambulation	Through the stay of the patient in ICU postoperatively, average of 2 days.	The time when the patient is ambulated in the ICU
Postoperative respiratory depression	24 hours after extubation	Determined by the need of oxygen support after extubation
Length of ICU stay	Through patient's stay inicu till discharge to ward, average of 3 days	The time patient spends in the ICU postoperatively

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Abbasya, Egypt