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

NCT ID: NCT05884164

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2025-03-30

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.

Conditions

ERAS; Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Erector spinae group

Patients will receive erector spinae plane block after general anaesthesia .

Group Type: ACTIVE_COMPARATOR

Thoracic erector spinae plane block

Intervention Type: 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

Paravertebral block group

Patients will receive paravertebral plane block after general anaesthesia .

Group Type: ACTIVE_COMPARATOR

Thoracic paravertebral plane block

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Galal A El Kadi, MD

Role: STUDY_CHAIR

Ain Shams University

Mohamed S Zaki, MD

Role: STUDY_CHAIR

Ain Shams University

Mona M Ammar, MD

Role: STUDY_CHAIR

Ain Shams University

Islam A Abdelmouty, MD

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Ain Shams University

Cairo, Abbasya, Egypt

Countries

Egypt

Other Identifiers

FMASU MD89 / 2022

Identifier Type: -

Identifier Source: org_study_id