CClinicalTrials.gg
Active, not recruitingNCT06870383Updated Jul 6, 2026

Erector Spinae Block Versus Combined Pecto-intercostal and Recto-intercostal Fascial Plane Block in Cardiac Surgery

An interventional study of Erector spinae plane block and Combined Pecto-intercostal and recto-intercostal fascial plane block in Erector Spinae Plane Block, Pecto-intercostal Fascial Plane Block and Recto-intercostal Fascial Plane Block, sponsored by Tanta University. Active, not recruiting at 1 site in Egypt. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Tanta University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Erector Spinae Plane Block
  • Pecto-intercostal Fascial Plane Block
  • Recto-intercostal Fascial Plane Block
  • Cardiac
  • Surgery

Keywords

  • Analgesic
  • Erector
  • Pectointercostal
  • Rectointercostal
  • Cardiac
03

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age from 21 to 65 years.
  • Both sexes.
  • Scheduled for open heart surgery with cardiopulmonary bypass and midline sternotomy.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Active comparator
    Erector spinae plane block group

    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.

    Drug: Erector spinae plane block

  • Experimental
    Combined Pecto-intercostal and recto-intercostal fascial plane block group

    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.

    Drug: Combined Pecto-intercostal and recto-intercostal fascial plane block

Interventions

  • DrugErector spinae plane block

    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.

  • DrugCombined Pecto-intercostal and recto-intercostal fascial plane block

    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..

06

What researchers measure

Primary outcomes

  1. The total opioid consumption in first 24 hours after surgery.

    opioid analgesia will be given if the pain scores ≥ 4.

    Time frame: 24 hours after surgery.

Secondary outcomes

  1. 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.

    Time frame: Until the end of surgical procedure.

  2. 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.

    Time frame: 48 hours after surgery.

  3. Extubation time

    Time from intensive care unit admission until successful removal of endotracheal tube will be recorded.

    Time frame: 24 hours after surgery.

  4. Side effects

    Hypotension , bradycardia, postoperative nausea and vomiting

    Time frame: 24 hours after surgery.

  5. 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.

    Time frame: 6 months after surgery.

  6. Opioid consumption in the second day after surgery.

    opioid analgesia will be given if the pain scores ≥ 4.

    Time frame: 48 hours after surgery.

07

Study locations

1 site
  • Tanta University Hospitals
    Tanta, Gharbia Governorate 31527, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon reasonable request from the corresponding author.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06870383
Lead sponsor
Tanta University
Responsible party
Osama Rehab (lecturer of anesthesiology, surgical intensive care and pain medicine, Tanta University) — Principal investigator
First posted
Mar 11, 2025
Start date
Mar 20, 2025
Primary completion
Jul 1, 2026
Completion
Jan 1, 2027 (estimated)
Last update
Jul 6, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion