search
Back to results

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

Primary Purpose

ERAS, Post Operative Pain

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Thoracic erector spinae plane block
Thoracic paravertebral plane block
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for ERAS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Erector spinae group

Paravertebral block group

Arm Description

Patients will receive erector spinae plane block after general anaesthesia .

Patients will receive paravertebral plane block after general anaesthesia .

Outcomes

Primary Outcome Measures

intraoperative opioid consumption
Fentanyl in micrograms intraoperatively
Postoperative opioid consumption
morphine in milligram postoperatively

Secondary Outcome Measures

Time for extubation
The time it took for the patient to be extubated in ICU
Time for ambulation
The time when the patient is ambulated in the ICU
Postoperative respiratory depression
Determined by respiratory rate
Postoperative respiratory depression
Determined by oxygen saturation
Postoperative respiratory depression
Determined by the need of oxygen support after extubation
Length of ICU stay
The time patient spends in the ICU postoperatively

Full Information

First Posted
April 1, 2023
Last Updated
May 22, 2023
Sponsor
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT05884164
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ERAS, Post Operative Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector spinae group
Arm Type
Active Comparator
Arm Description
Patients will receive erector spinae plane block after general anaesthesia .
Arm Title
Paravertebral block group
Arm Type
Active Comparator
Arm Description
Patients will receive paravertebral plane block after general anaesthesia .
Intervention Type
Procedure
Intervention Name(s)
Thoracic erector spinae plane block
Intervention Description
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
Intervention Name(s)
Thoracic paravertebral plane block
Intervention Description
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 Outcome Measure Information:
Title
intraoperative opioid consumption
Description
Fentanyl in micrograms intraoperatively
Time Frame
Through intraoperative period, average of 6 hours
Title
Postoperative opioid consumption
Description
morphine in milligram postoperatively
Time Frame
For 24 hours after extubation
Secondary Outcome Measure Information:
Title
Time for extubation
Description
The time it took for the patient to be extubated in ICU
Time Frame
24 hours postoperative
Title
Time for ambulation
Description
The time when the patient is ambulated in the ICU
Time Frame
Through the stay of the patient in ICU postoperatively, average of 2 days.
Title
Postoperative respiratory depression
Description
Determined by respiratory rate
Time Frame
24 hours after extubation
Title
Postoperative respiratory depression
Description
Determined by oxygen saturation
Time Frame
24 hours after extubation
Title
Postoperative respiratory depression
Description
Determined by the need of oxygen support after extubation
Time Frame
24 hours after extubation
Title
Length of ICU stay
Description
The time patient spends in the ICU postoperatively
Time Frame
Through patient's stay inicu till discharge to ward, average of 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galal A El Kadi, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed S Zaki, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mona M Ammar, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Ain Shams University
City
Cairo
State/Province
Abbasya
ZIP/Postal Code
11213
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs