ERASNCT05884164
ESPB Versus PVPB Regarding Their Effect on Peri-operative Opioid Consumption in Patients Undergoing Minimally Invasive Mitral Valve Replacement
A study testing Thoracic erector spinae plane block and Thoracic paravertebral plane block in people with ERAS and Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ERAS, Post Operative Pain
- What is being tested?
- Thoracic erector spinae plane block and Thoracic paravertebral plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Mar 2022to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 .
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.
Read the 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
- Being tested
- Thoracic erector spinae plane block, Thoracic paravertebral plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic erector spinae plane blockProcedure or surgery
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 blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae group | Active comparator | Patients will receive erector spinae plane block after general anaesthesia . Receives: Procedure: Thoracic erector spinae plane block |
| Paravertebral block group | Active comparator | Patients will receive paravertebral plane block after general anaesthesia . Receives: Procedure: Thoracic paravertebral plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative opioid consumption
Fentanyl in micrograms intraoperatively
Measured: Through intraoperative period, average of 6 hours
Postoperative opioid consumption
morphine in milligram postoperatively
Measured: For 24 hours after extubation
Secondary outcomes (6)
Time for extubation
The time it took for the patient to be extubated in ICU
Measured: 24 hours postoperative
Time for ambulation
The time when the patient is ambulated in the ICU
Measured: Through the stay of the patient in ICU postoperatively, average of 2 days.
Postoperative respiratory depression
Determined by respiratory rate
Measured: 24 hours after extubation
Postoperative respiratory depression
Determined by oxygen saturation
Measured: 24 hours after extubation
Postoperative respiratory depression
Determined by the need of oxygen support after extubation
Measured: 24 hours after extubation
Length of ICU stay
The time patient spends in the ICU postoperatively
Measured: Through patient's stay inicu till discharge to ward, average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start24 Mar 2022
- Primary completion7 Oct 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERASStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Galal A El Kadi, MD, Study chair, Ain Shams UniversityMohamed S Zaki, MD, Study chair, Ain Shams UniversityMona M Ammar, MD, Study chair, Ain Shams UniversityIslam A Abdelmouty, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884164
- Sponsor's protocol ID
- FMASU MD89 / 2022
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2023
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 .
- ClinicalTrials.gov ID
- NCT05884164
- Acronym / sponsor ID
- FMASU MD89 / 2022
- Conditions
- ERAS, Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae group | Active comparator | Procedure: Thoracic erector spinae plane blockPatients will receive erector spinae plane block after general anaesthesia . |
| Paravertebral block group | Active comparator | Procedure: Thoracic paravertebral plane blockPatients will receive paravertebral plane block after general anaesthesia . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic erector spinae plane blockAfter 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 | Procedure or surgery | Erector spinae group |
| Thoracic paravertebral plane blockAfter 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. | Procedure or surgery | Paravertebral block group |
Primary outcome
intraoperative opioid consumption
Time frame: Through intraoperative period, average of 6 hours
Fentanyl in micrograms intraoperatively
Postoperative opioid consumption
Time frame: For 24 hours after extubation
morphine in milligram postoperatively
6 secondary outcomes
Time for extubation
Time frame: 24 hours postoperative
Time for ambulation
Time frame: Through the stay of the patient in ICU postoperatively, average of 2 days.
Postoperative respiratory depression
Time frame: 24 hours after extubation
Postoperative respiratory depression
Time frame: 24 hours after extubation
Postoperative respiratory depression
Time frame: 24 hours after extubation
Length of ICU stay
Time frame: Through patient's stay inicu till discharge to ward, average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for ERAS
Recruiting
Comparison of Post-operative Outcomes Between ERAS Protocol and Non-ERAS Local Regimen in Patients Undergoing Thyroidectomy
Thyroid Diseases, Ambulation Time
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
RecruitingPhase 4
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
Pain, Post Operative Analgesia
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
RecruitingPhase 3
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Gynecologic Cancer, Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galal A El Kadi, MD study chair
Ain Shams University
Mohamed S Zaki, MD study chair
Ain Shams University
Mona M Ammar, MD study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic erector spinae plane block and Thoracic paravertebral plane block in people with ERAS and Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative opioid consumption (time frame: Through intraoperative period, average of 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.