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Completed

NCT Number: NCT05884164

ESPB Versus PVPB 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Abbasya, 11213, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. intraoperative opioid consumption

    Time frame: Through intraoperative period, average of 6 hours

    Fentanyl in micrograms intraoperatively

  2. Postoperative opioid consumption

    Time frame: For 24 hours after extubation

    morphine in milligram postoperatively

Secondary outcomes

  1. Time for extubation

    Time frame: 24 hours postoperative

    The time it took for the patient to be extubated in ICU

  2. Time for ambulation

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

    The time when the patient is ambulated in the ICU

  3. Postoperative respiratory depression

    Time frame: 24 hours after extubation

    Determined by respiratory rate

  4. Postoperative respiratory depression

    Time frame: 24 hours after extubation

    Determined by oxygen saturation

  5. Postoperative respiratory depression

    Time frame: 24 hours after extubation

    Determined by the need of oxygen support after extubation

  6. Length of ICU stay

    Time frame: Through patient's stay inicu till discharge to ward, average of 3 days

    The time patient spends in the ICU postoperatively

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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 .

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 1, 2023
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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