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

Comparative Study: Erector Spinae Plane Block Versus Paravertebral Plane Block Regarding Their Effect on Peri-operative Opioid Consumption in Patients Undergoing Minimally Invasive Mitral Valve Replacement .

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain; ERAS
• Intervention / Treatment: Procedure: Thoracic erector spinae plane block; Procedure: Thoracic paravertebral plane block

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbasya
    • Cairo, Abbasya, Egypt, 11213
      • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erector spinae group; Patients will receive erector spinae plane block after general anaesthesia .	Procedure: Thoracic erector spinae plane block; After induction of general Anaesthesia,a high frequency ultrasound probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinal muscle and the transverse processes are identified, spinal needle will be inserted after standard skin disinfection in a caudal to cephalad direction using a sterile probe cover until the tip lay in the interfacial plane deep to the erector spinal muscle. After hydrolocalization with ml normal saline, this plane will be opened and 20 ml of 0.25 %bupivacaine will be administered for block performance
Active Comparator: Paravertebral block group; Patients will receive paravertebral plane block after general anaesthesia .	Procedure: Thoracic paravertebral plane block; After induction of general Anaesthesia ,with the probe in the longitudinal paramedian position, it is then moved from medial to lateral direction to appreciate the saw tooth appearance of the facet joints close to the midline which changes to long finger-like shadow of the transverse process as the probe is moved slightly laterally. Repositioning the probe over the transverse process ensuring the space of interest is in the middle of the probe once again one should appreciate the intercostal muscles and the dense bright white line of the pleura in between the shadows of the transverse processes. The needle is then introduced at the caudal end of the probe in plane in a caudal to cranial direction aiming for the angle between the bottom of the transverse process and the pleura. Once position is confirmed, 20 ml of 0.25% bupivacaine will be administered for the block performance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative opioid consumption	Fentanyl in micrograms intraoperatively	Through intraoperative period, average of 6 hours
Postoperative opioid consumption	morphine in milligram postoperatively	For 24 hours after extubation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Galal A El Kadi, MD, Ain Shams University; Study Chair: Mohamed S Zaki, MD, Ain Shams University; Study Chair: Mona M Ammar, MD, Ain Shams University; Study Director: Islam A Abdelmouty, MD, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Actual): October 7, 2024
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: April 1, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: FMASU MD89 / 2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No