Clinical trial NCT05884164: ESPB Versus PVPB Regarding Their Effect on Peri-operative Opioid Consumption in Patients Undergoing Minimally Invasive Mitral Valve Replacement
Official 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 .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ERAS
Post Operative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: intraoperative opioid consumption
timeFrame: Through intraoperative period, average of 6 hours
measure: Postoperative opioid consumption
timeFrame: For 24 hours after extubation
Secondary outcomes:
measure: Time for extubation
timeFrame: 24 hours postoperative
measure: Time for ambulation
timeFrame: Through the stay of the patient in ICU postoperatively, average of 2 days.
measure: Postoperative respiratory depression
timeFrame: 24 hours after extubation
measure: Postoperative respiratory depression
timeFrame: 24 hours after extubation
measure: Postoperative respiratory depression
timeFrame: 24 hours after extubation
measure: Length of ICU stay
timeFrame: Through patient's stay inicu till discharge to ward, average of 3 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbasya
Study officials:
affiliation: Ain Shams University
name: Galal A El Kadi, MD
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Mohamed S Zaki, MD
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Mona M Ammar, MD
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Islam A Abdelmouty, MD
role: STUDY_DIRECTOR
References: