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

NCT05884164 | Completed DMC

• 1 other identifier: FMASU MD89 / 2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

ERAS; Post Operative Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Time for extubation

  24 hours postoperative

• Time for ambulation

  Through the stay of the patient in ICU postoperatively, average of 2 days.

• Postoperative respiratory depression

  24 hours after extubation

• Postoperative respiratory depression

  24 hours after extubation

• Postoperative respiratory depression

  24 hours after extubation

Study Arms (2)

Erector spinae group

ACTIVE COMPARATOR

Patients will receive erector spinae plane block after general anaesthesia .

Procedure: Thoracic erector spinae plane block

Paravertebral block group

ACTIVE COMPARATOR

Patients will receive paravertebral plane block after general anaesthesia .

Procedure: Thoracic paravertebral plane block

Interventions

Thoracic erector spinae plane block PROCEDURE

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

Erector spinae group

Thoracic paravertebral plane block PROCEDURE

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.

Paravertebral block group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasya, 11213, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• 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 CHAIR

• Islam A Abdelmouty, MD

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2023
• First Posted: June 1, 2023
• Study Start: March 24, 2022
• Primary Completion: October 7, 2024
• Study Completion: March 30, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)