Erector Spinae Plane BlockNCT06870383
Erector Spinae Block Versus Combined Pecto-intercostal and Recto-intercostal Fascial Plane Block in Cardiac Surgery
A study testing Erector spinae plane block and Combined Pecto-intercostal and recto-intercostal fascial plane block in people with Erector Spinae Plane Block and Pecto-intercostal Fascial Plane Block, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the analgesic effects of ultrasound-guided bilateral erector spinae plane block versus ultrasound-guided bilateral combined Pecto-intercostal fascial plane block and recto-intercostal fascial plane block in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Erector Spinae Plane Block, Pecto-intercostal Fascial Plane Block, Recto-intercostal Fascial Plane Block
- What is being tested?
- Erector spinae plane block and Combined Pecto-intercostal and recto-intercostal fascial plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 21 to 65 years.
- Both sexes.
- Scheduled for open heart surgery with cardiopulmonary bypass and midline sternotomy.
Who cannot join
- History of chronic pain or Long-term or recent use of opioids.
- History of allergy to local anesthetic drugs.
- Ejection fraction of left ventricle less than 30%.
- History of psychiatric diseases or any neurological disorders.
- Pre-existing major organ dysfunction as hepatic or renal failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Erector Spinae Plane Block Versus Combined Pecto-intercostal and Recto-intercostal Fascial Plane Block in Patients Undergoing Cardiac Surgery: A Randomized Comparative Trial
The aim of this study is to compare the analgesic effects of ultrasound-guided bilateral erector spinae plane block versus ultrasound-guided bilateral combined Pecto-intercostal fascial plane block and recto-intercostal fascial plane block in patients undergoing cardiac surgery.
Read the detailed description
The incidence of severe acute postoperative pain after median sternotomy is as high as 49 %. A number of regional techniques have been used to treat sternotomy pain such as thoracic epidural, intercostal nerve block, paravertebral nerve block \& thoracic erector spinae plane block which has been used extensively in cardiac surgery providing adequate postoperative pain control. Pecto-intercostal fascial plane block is a minimally invasive, regional fascial plane block technique that can be administered as a part of a multimodal analgesic regimen. It targets the anterior intercostal nerves as they run in the fascial plane between the pectoralis major muscle and the external intercostal muscles and emerge on either side of the sternum. Recently, Tulgar et al. have described a novel block named "recto-intercostal fascial plane block" which is performed between the rectus abdominis muscle and costal cartilages of ribs 6-7 (insertion of RAM). In their cadaveric examination, they reported that the dye spread extensively to the anterior branches of the T6-T9 thoracic nerves, and laterally to the entire lower thorax. The investigators assume that the incomplete dermatome coverage by Pecto-intercostal fascial plane block might be responsible for its inferior analgesic quality compared to erector spinae plane block which was reported in some previous reports. So, the investigators will conduct this novel study to investigate and compare the analgesic effects of erector spinae plane block and combined Pecto-intercostal fascial plane block and recto-intercostal fascial plane block in patients undergoing cardiac surgery.
- Conditions
- Erector Spinae Plane Block, Pecto-intercostal Fascial Plane Block, Recto-intercostal Fascial Plane Block, Cardiac, Surgery
- Being tested
- Erector spinae plane block, Combined Pecto-intercostal and recto-intercostal fascial plane block
- Keywords
- Analgesic, Erector, Pectointercostal, Rectointercostal, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockDrug
The block will be done under ultrasound guidance using 20 ml bupivacaine 0.25% that will be injected for each side ensuring not to exceed the maximal 2 mg/kg bupivacaine dose.
Combined Pecto-intercostal and recto-intercostal fascial plane blockDrug
The blocks will be done under ultrasound guidance using 10-15 ml of 0.25% bupivacaine that will be injected for each side ensuring not to exceed the maximal 2 mg/kg bupivacaine dose..
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block group | Active comparator | At the level of fourth thoracic vertebra, the ultrasound transducer (5-14 Mhz) Philips CX50 will be placed in the sagittal plane and moved 3 cm to visualize the transverse process of T4 or T5 with erector spinae muscle overlying it, the needle will be inserted in plane into the facial plane deep to the erector spinae muscle with the tip contacting the transverse process of T4 or T5. After confirmation by 5 ml saline, 20 ml bupivacaine 0.25% will be injected for each side ensuring not to exceed the maximal 2 mg/kg bupivacaine dose. Receives: Drug: Erector spinae plane block |
| Combined Pecto-intercostal and recto-intercostal fascial plane block group | Experimental | A high-frequency ultrasound transducer will be placed 2 cm lateral to sternal edge at the level of 4th rib. A needle will be inserted in-plane under ultrasound guidance through the pectoralis major muscle, and the drug will be deposited in the pecto-intercostal fascial plane located between the pectoralis major muscle and the fourth rib (or intercostal muscle) after confirmation by 5 ml saline. 10-15 mL of 0.25% bupivacaine will be injected for each side. Then the transducer will be placed 2-3 cm lateral and caudal to the xiphoid in the epigastric area.The needle will be inserted between RAM and the costal cartilages with an in-plane technique in a caudo-cranial way. Hydro-dissection will be performed with 5 ml saline for confirmation needle tip position, 10-15 mL of 0.25% bupivacaine will be injected for each side. Receives: Drug: Combined Pecto-intercostal and recto-intercostal fascial plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total opioid consumption in first 24 hours after surgery.
opioid analgesia will be given if the pain scores ≥ 4.
Measured: 24 hours after surgery.
Secondary outcomes (6)
Intraoperative fentanyl dose
Fentanyl bolus dosages of 2μg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline.
Measured: Until the end of surgical procedure.
Postoperative pain scores after extubation, at 8, 12, 18, 24, 36, and 48 hour after surgery.
Numerical rating scale pain score (NRS) ranges from 0= no pain to 10= worst pain will be used to evaluate pain scores after surgery.
Measured: 48 hours after surgery.
Extubation time
Time from intensive care unit admission until successful removal of endotracheal tube will be recorded.
Measured: 24 hours after surgery.
Side effects
Hypotension , bradycardia, postoperative nausea and vomiting
Measured: 24 hours after surgery.
Incidence of chronic pain at 3, and 6 months after surgery.
chronic pain will be assessed and its severity graded by rating scale will be recorded.
Measured: 6 months after surgery.
Opioid consumption in the second day after surgery.
opioid analgesia will be given if the pain scores ≥ 4.
Measured: 48 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start20 Mar 2025
- Primary completion1 Jul 2026
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane BlockStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Rehab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870383
- Sponsor's protocol ID
- 36264PR1085/2/25
- Status last verified
- Jul 2026
- First submitted
- 6 Mar 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Erector Spinae Plane Block Versus Combined Pecto-intercostal and Recto-intercostal Fascial Plane Block in Patients Undergoing Cardiac Surgery: A Randomized Comparative Trial
- ClinicalTrials.gov ID
- NCT06870383
- Acronym / sponsor ID
- 36264PR1085/2/25
- Conditions
- Erector Spinae Plane Block, Pecto-intercostal Fascial Plane Block, Recto-intercostal Fascial Plane Block, Cardiac, Surgery
- Keywords
- Analgesic, Erector, Pectointercostal, Rectointercostal, Cardiac
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 11 Mar 2025 (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.
The aim of this study is to compare the analgesic effects of ultrasound-guided bilateral erector spinae plane block versus ultrasound-guided bilateral combined Pecto-intercostal fascial plane block and recto-intercostal fascial plane block in patients undergoing cardiac surgery.
Detailed description
The incidence of severe acute postoperative pain after median sternotomy is as high as 49 %. A number of regional techniques have been used to treat sternotomy pain such as thoracic epidural, intercostal nerve block, paravertebral nerve block \& thoracic erector spinae plane block which has been used extensively in cardiac surgery providing adequate postoperative pain control. Pecto-intercostal fascial plane block is a minimally invasive, regional fascial plane block technique that can be administered as a part of a multimodal analgesic regimen. It targets the anterior intercostal nerves as they run in the fascial plane between the pectoralis major muscle and the external intercostal muscles and emerge on either side of the sternum. Recently, Tulgar et al. have described a novel block named "recto-intercostal fascial plane block" which is performed between the rectus abdominis muscle and costal cartilages of ribs 6-7 (insertion of RAM). In their cadaveric examination, they reported that the dye spread extensively to the anterior branches of the T6-T9 thoracic nerves, and laterally to the entire lower thorax. The investigators assume that the incomplete dermatome coverage by Pecto-intercostal fascial plane block might be responsible for its inferior analgesic quality compared to erector spinae plane block which was reported in some previous reports. So, the investigators will conduct this novel study to investigate and compare the analgesic effects of erector spinae plane block and combined Pecto-intercostal fascial plane block and recto-intercostal fascial plane block in patients undergoing cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block group | Active comparator | Drug: Erector spinae plane blockAt the level of fourth thoracic vertebra, the ultrasound transducer (5-14 Mhz) Philips CX50 will be placed in the sagittal plane and moved 3 cm to visualize the transverse process of T4 or T5 with erector spinae muscle overlying it, the needle will be inserted in plane into the facial plane deep to the erector spinae muscle with the tip contacting the transverse process of T4 or T5. After confirmation by 5 ml saline, 20 ml bupivacaine 0.25% will be injected for each side ensuring not to exceed the maximal 2 mg/kg bupivacaine dose. |
| Combined Pecto-intercostal and recto-intercostal fascial plane block group | Experimental | Drug: Combined Pecto-intercostal and recto-intercostal fascial plane blockA high-frequency ultrasound transducer will be placed 2 cm lateral to sternal edge at the level of 4th rib. A needle will be inserted in-plane under ultrasound guidance through the pectoralis major muscle, and the drug will be deposited in the pecto-intercostal fascial plane located between the pectoralis major muscle and the fourth rib (or intercostal muscle) after confirmation by 5 ml saline. 10-15 mL of 0.25% bupivacaine will be injected for each side. Then the transducer will be placed 2-3 cm lateral and caudal to the xiphoid in the epigastric area.The needle will be inserted between RAM and the costal cartilages with an in-plane technique in a caudo-cranial way. Hydro-dissection will be performed with 5 ml saline for confirmation needle tip position, 10-15 mL of 0.25% bupivacaine will be injected for each side. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 21 to 65 years.
- Both sexes.
- Scheduled for open heart surgery with cardiopulmonary bypass and midline sternotomy.
Key exclusion criteria (5 listed)
- History of chronic pain or Long-term or recent use of opioids.
- History of allergy to local anesthetic drugs.
- Ejection fraction of left ventricle less than 30%.
- History of psychiatric diseases or any neurological disorders.
- Pre-existing major organ dysfunction as hepatic or renal failure.
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 |
|---|---|---|
| Erector spinae plane blockThe block will be done under ultrasound guidance using 20 ml bupivacaine 0.25% that will be injected for each side ensuring not to exceed the maximal 2 mg/kg bupivacaine dose. | Drug | Erector spinae plane block group |
| Combined Pecto-intercostal and recto-intercostal fascial plane blockThe blocks will be done under ultrasound guidance using 10-15 ml of 0.25% bupivacaine that will be injected for each side ensuring not to exceed the maximal 2 mg/kg bupivacaine dose.. | Drug | Combined Pecto-intercostal and recto-intercostal fascial plane block group |
Primary outcome
The total opioid consumption in first 24 hours after surgery.
Time frame: 24 hours after surgery.
opioid analgesia will be given if the pain scores ≥ 4.
6 secondary outcomes
Intraoperative fentanyl dose
Time frame: Until the end of surgical procedure.
Postoperative pain scores after extubation, at 8, 12, 18, 24, 36, and 48 hour after surgery.
Time frame: 48 hours after surgery.
Extubation time
Time frame: 24 hours after surgery.
Side effects
Time frame: 24 hours after surgery.
Incidence of chronic pain at 3, and 6 months after surgery.
Time frame: 6 months after surgery.
Opioid consumption in the second day after surgery.
Time frame: 48 hours after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block and Combined Pecto-intercostal and recto-intercostal fascial plane block in people with Erector Spinae Plane Block and Pecto-intercostal Fascial Plane Block, run by Tanta 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 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The total opioid consumption in first 24 hours after surgery. (time frame: 24 hours after surgery.). 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 6 Jul 2026.