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Postoperative Pain Following Coronary Artery Bypass Grafting (CABG)PACTNCT07658521

Combined SPSP and TTP Blocks for Postoperative Analgesia Post-CABG

A study testing Transversus Thoracic Plane Block, Transversus Thoracic Plane (TTP) Block and Conventional Systemic Analgesia in people with Postoperative Pain Following Coronary Artery Bypass Grafting (CABG), run by Ain Shams University at 1 site in Egypt.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if combining two ultrasound-guided nerve blocks - one for the front of the chest and one for the side of the chest - works better than standard pain medications alone to treat pain after coronary artery bypass grafting (CABG) surgery. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Transversus Thoracic Plane Block, Transversus Thoracic Plane (TTP) Block and Conventional Systemic Analgesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteEgypt
Study dates
1 Jul 2026to 15 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18-65 years.
  • Scheduled for elective, isolated CABG via median sternotomy.
  • American Society of Anesthesiologists (ASA) physical status II-III.
  • Ability to understand the study procedures, provide written informed consent, and reliably report pain scores using the NRS.

Who cannot join

  • Emergency surgery or pre-operative hemodynamics instability.
  • Known allergies or hypersensitivity to local anesthetics, paracetamol, morphine, or any study medication.
  • Coagulopathy, uncontrolled bleeding risk, or therapeutic anticoagulation that cannot be safely withheld per institutional guidelines (INR > 1.5; platelets < 100 × 10⁹/L at time of block).
  • Local infection or cellulitis at any planned injection site on the anterior or lateral chest wall.
  • Pre-existing chronic pain syndrome requiring daily opioid analgesia or known opioid dependence.
  • Significant cognitive impairment, severe psychiatric disorder, or inability to reliably use pain scales.
Show all 10Show fewer
  • History of prior thoracic surgery or major chest wall deformity distorting anatomy or limiting the ultrasound window.
  • Pregnancy or breastfeeding.
  • Any other condition judged by the investigator to represent unacceptable risk or preclude study participation.
  • Patient refusal or withdrawal of consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site
  • Ain Shams University Hospitals

    Cairo, Cairo Governorate, 1181

Other trials in Egypt

About this study

Official title: Ultrasound-Guided Serratus Posterior Superior Plane and Transversus Thoracic Plane Blocks for Postoperative Analgesia After Coronary Artery Bypass Grafting: A Randomized Controlled Trial

The goal of this clinical trial is to learn if combining two ultrasound-guided nerve blocks - one for the front of the chest and one for the side of the chest - works better than standard pain medications alone to treat pain after coronary artery bypass grafting (CABG) surgery. It will also learn about the safety of these nerve blocks. The main questions it aims to answer are:

Does the combined nerve block approach lower the amount of opioid pain medication needed in the first 24 hours after surgery? Does the combined nerve block approach lower pain scores at rest and with movement compared to standard care? What medical problems do participants have when receiving the nerve blocks (such as bleeding, infection, or effects from the local anesthetic)? Researchers will compare the combined nerve block group to a standard care group (no nerve blocks) to see if the blocks improve pain control and recovery after heart surgery.

Read more

Participants will:

Be randomly assigned to one of two groups: (1) combined nerve blocks plus standard pain medications, or (2) standard pain medications alone Receive the nerve blocks during surgery while under general anesthesia (if assigned to the block group) Have their pain levels checked regularly using a 0-10 scale for the first 48 hours after surgery Have their breathing, walking time, and opioid medication use monitored during their hospital stay Complete a satisfaction survey about their pain management before leaving the hospital Stay in the hospital for their routine recovery period (typically 5-7 days) with no extra visits required

Read the detailed description

This is a single-center, patient- and outcome-assessor-blinded, randomized controlled trial conducted at Ain Shams University Hospitals, Cairo, Egypt. Adults aged 18-75 years scheduled for elective isolated CABG via median sternotomy will be enrolled.

Eligible participants will be randomized 1:1 to either:

Intervention group: Bilateral transversus thoracic plane (TTP) block + bilateral serratus posterior superior (SPSP) block with 0.25% bupivacaine (15 mL per side per block, total 60 mL = 150 mg), performed after induction of general anesthesia and before surgical incision, plus standardized multimodal systemic analgesia.

Control group: Standardized multimodal systemic analgesia alone (no nerve blocks).

Both groups will receive identical standardized anesthesia (fentanyl, propofol, atracurium, sevoflurane), intraoperative hemodynamic management, and postoperative analgesia (IV paracetamol 1 g q6h scheduled, IV ketorolac 30 mg q8h for 24h then 15 mg q8h, rescue IV morphine via protocolized algorithm and patient-controlled analgesia).

The primary endpoint is cumulative 24-hour postoperative opioid consumption (IV morphine milligram equivalents) from extubation. Secondary endpoints include NRS pain scores at rest and with movement at 0, 6, 12, 24, and 48 hours; time to first rescue analgesia; time to first ambulation; respiratory outcomes (time to extubation, PaO₂/FiO₂ ratio, pulmonary complications); hemodynamic stability; ICU and hospital length of stay; patient satisfaction (Likert 1-5); and safety outcomes (block-related complications, LAST, opioid-related adverse events).

Sample size: 88 patients (44 per group), calculated for 80% power to detect a 30% reduction in 24-hour opioid consumption (Cohen's d = 0.60) at α = 0.05, with 15% dropout allowance.

Randomization will be computer-generated with permuted blocks (sizes 4 and 6), stratified by on-pump versus off-pump status and sex. Allocation concealment via sequentially numbered opaque sealed envelopes. Blinding: patients, outcome assessors, ICU staff, data collectors, statisticians, and non-performing anesthesiologists/surgeons will be blinded; only the performing anesthesiologist will be unblinded.

A Data and Safety Monitoring Board will review unblinded safety data at 25% and 50% enrollment. Stopping rules: any death attributable to intervention, ≥2 symptomatic pneumothoraces, or ≥2 severe LAST events.

Statistical analysis: ITT as primary population, per-protocol for sensitivity. Primary analysis: ANCOVA adjusting for age, sex, BMI, on-pump status, and intraoperative opioid dose. Missing data handled via multiple imputation (MICE, 20 datasets) with sensitivity analyses.

Being tested
Transversus Thoracic Plane Block, Transversus Thoracic Plane (TTP) Block, Conventional Systemic Analgesia, Bupivacaine 0.25%
Keywords
CABG, Postoperative pain, Serratus posterior superior plane block, Transversus thoracic plane block, Ultrasound-guided nerve block, Cardiac surgery
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transversus Thoracic Plane BlockProcedure or surgery

    Bilateral ultrasound-guided transversus thoracic plane block with 0.25% bupivacaine (15 mL per side, 30 mL total = 75 mg). Local anesthetic is deposited in the fascial plane between the transversus thoracic muscle and the internal intercostal muscles at the 2nd-4th intercostal space level, blocking the anterior cutaneous branches of T2-T6 intercostal nerves for parasternal analgesia. Performed after induction of general anesthesia using a 22G echogenic needle with in-plane ultrasound guidance.

  • Transversus Thoracic Plane (TTP) BlockProcedure or surgery

    Bilateral ultrasound-guided transversus thoracic plane block with 0.25% bupivacaine (15 mL per side, 30 mL total = 75 mg). Local anesthetic is deposited in the fascial plane between the transversus thoracic muscle and the internal intercostal muscles at the 2nd-4th intercostal space level, blocking the anterior cutaneous branches of T2-T6 intercostal nerves for parasternal analgesia. Performed after induction of general anesthesia using a 22G echogenic needle with in-plane ultrasound guidance.

  • Conventional Systemic AnalgesiaDrug

    Standardized multimodal systemic analgesia regimen administered to both groups. Intraoperative: fentanyl 5-10 mcg/kg at induction with supplemental 1-2 mcg/kg boluses as needed. Postoperative: IV paracetamol 1 g every 6-8 hours scheduled; IV ketorolac 30 mg every 8 hours for 24 hours then 15 mg every 8 hours; rescue IV morphine 2-3 mg every 5-10 minutes titrated to NRS ≤ 3 for NRS ≥ 4, followed by morphine patient-controlled analgesia (1 mg bolus, 5-minute lockout, 10 mg/hour limit, no background infusion).

  • Bupivacaine 0.25%Drug

    Local anesthetic administered for regional blocks; total dose up to 2.5 mg/kg (maximum 150 mg for patients ≥65 kg, adjusted for lower weights)

Study groups in NCT07658521
Study groupRoleWhat they receive
Combined SPSP + TTP BlockExperimentalParticipants receive bilateral ultrasound-guided serratus posterior superior (SPSP) plane block and bilateral transversus thoracic plane (TTP) block.
Receives: Procedure: Transversus Thoracic Plane Block; Procedure: Transversus Thoracic Plane (TTP) Block; Drug: Conventional Systemic Analgesia; Drug: Bupivacaine 0.25%
Conventional Analgesia GroupActive comparatorParticipants receive standardized multimodal systemic analgesia alone without any regional anesthesia blocks.
Receives: Drug: Conventional Systemic Analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accumulated from time of tracheal extubation through 48 hours post-extubation

    Cumulative intravenous morphine milligram equivalents (MME) from tracheal extubation (time 0) to 48 hours post-extubation. All opioid doses administered during this period will be recorded and converted to IV MME using standardized conversion ratios: fentanyl 1 mcg IV = 0.1 mg IV morphine equivalent; hydromorphone 1 mg IV = 5 mg IV morphine equivalent; oxycodone 1 mg oral = 1.5 mg IV morphine equivalent; tramadol 1 mg IV = 0.1 mg IV morphine equivalent. The primary analysis will compare total 48-hour MME between the combined SPSP + TTP block group and the conventional analgesia group.

    Measured: rom time of tracheal extubation until administration of first rescue IV morphine dose for NRS ≥ 4, assessed up to 48 hours post-extubation

Secondary outcomes (12)
  1. NRS pain score at rest

    Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) assessed at rest at extubation (0 h), 6 h, 12 h, 24 h, and 48 h post-extubation.

    Measured: Assessed at extubation (0 h), 6 hours, 12 hours, 24 hours, and 48 hours post-extubation

  2. NRS pain score on movement/coughing

    Numeric Rating Scale (0-10) assessed during deep inspiration, coughing, or turning in bed at 0 h, 6 h, 12 h, 24 h, and 48 h post-extubation.

    Measured: Assessed at extubation (0 h), 6 hours, 12 hours, 24 hours, and 48 hours post-extubation

  3. Time to first rescue analgesic

    Minutes from tracheal extubation to first administration of rescue opioid for Numeric Rating Scale ≥ 4 at rest or on patient demand. Rescue protocol: IV morphine 2-3 mg every 5-10 minutes titrated to NRS ≤ 3. Recorded by blinded ICU nursing staff.

    Measured: From time of tracheal extubation until administration of first rescue IV morphine dose for NRS ≥ 4, assessed up to 48 hours post-extubation

  4. Time to tracheal extubation

    Minutes from end of surgery (skin closure) to successful tracheal extubation in the intensive care unit. Successful extubation defined as removal of endotracheal tube with spontaneous breathing maintained for at least 30 minutes without reintubation.

    Measured: From end of surgery (skin closure) until successful removal of endotracheal tube and spontaneous breathing without ventilatory support, assessed up to 48 hours

  5. Arterial oxygenation (PaO₂/FiO₂ ratio)

    Arterial oxygen tension to inspired oxygen fraction ratio measured at 6 hours and 24 hours post-extubation

    Measured: Assessed at 6 hours and 24 hours post-extubation

  6. Incidence of atelectasis

    incidence of atelectasis (radiographic confirmation)

    Measured: From time of tracheal extubation until hospital discharge or postoperative day 30, whichever occurs first

  7. Incentive spirometry volume

    Volume achieved with incentive spirometry in millilitres at 24 and 48 hours post-extubation. Assessed by a blinded physiotherapist or nursing staff using standardized technique.

    Measured: Assessed at 24 hours and 48 hours post-extubation

  8. Pulmonary complications

    Incidence of atelectasis (radiographic confirmation), pneumonia (clinical and radiographic criteria per CDC definitions), or reintubation occurring during the hospital stay. Composite binary outcome.

    Measured: From time of tracheal extubation until hospital discharge or postoperative day 30, whichever occurs first

  9. Intensive care unit length of stay

    Hours from intensive care unit admission to ICU discharge to the ward. Discharge criteria per institutional protocol: hemodynamic stability without vasopressors, adequate oxygenation on room air or low-flow oxygen, and no active arrhythmias requiring intervention.

    Measured: From ICU admission until ICU discharge, assessed up to 7 days postoperatively

  10. Hospital length of stay

    Days from surgery (admission) to hospital discharge. Discharge criteria per institutional protocol: ambulatory, pain controlled on oral analgesics, wound healing satisfactory, and no active medical issues requiring inpatient management.

    Measured: From date of surgery until date of hospital discharge, assessed up to 30 days postoperatively

  11. Patient satisfaction with pain management

    Likert scale 1-5 (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied) assessing overall satisfaction with postoperative pain management at 48 hours post-extubation. Completed by patient with blinded assessor assistance if needed.

    Measured: Assessed at 48 hours post-extubation using a 5-point Likert scale

  12. Time to first ambulation

    Hours from tracheal extubation to first assisted ambulation greater than 10 metres. Ambulation is defined as standing and walking with or without assistance. Recorded by blinded ICU or ward physiotherapy staff.

    Measured: From time of tracheal extubation until first documented assisted or unassisted ambulation, assessed up to 7 days postoperatively or until hospital discharge, whichever occurs first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion15 Jan 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomly assigned to one of two treatment groups in a 1:1 ratio. Group 1 receives combined ultrasound-guided serratus posterior superior and transversus thoracic plane blocks plus standardized systemic analgesia. Group 2 receives standardized systemic analgesia alone (no nerve blocks). Both groups undergo identical anesthesia and surgical management. Outcomes are compared between the two parallel groups.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07658521
Sponsor's protocol ID
FAMSU R30/2026
Acronym
PACT
Status last verified
Jun 2026
First submitted
11 Jun 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying published results will be shared with qualified researchers upon reasonable request to the principal investigator, subject to approval by the Ain Shams University IRB and execution of a data use agreement.

Publications

  • Shokri H, Ali I, Kasem AA. Evaluation of the Analgesic Efficacy of Bilateral Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Post-Sternotomy Pain: A Randomized Controlled Trial. Local Reg Anesth. 2021 Nov 12;14:145-152. doi: 10.2147/LRA.S338685. eCollection 2021.

    PubMed 34803399
  • Murata H, Hida K, Hara T. Transverse Thoracic Muscle Plane Block: Tricks and Tips to Accomplish the Block. Reg Anesth Pain Med. 2016 May-Jun;41(3):411-2. doi: 10.1097/AAP.0000000000000374. No abstract available.

    PubMed 27093277
  • Ueshima H, Hara E, Marui T, Otake H. RETRACTED: The ultrasound-guided transversus thoracic muscle plane block is effective for the median sternotomy. J Clin Anesth. 2016 Mar;29:83. doi: 10.1016/j.jclinane.2015.10.014. Epub 2016 Feb 9. No abstract available.

    PubMed 26897453
  • Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.

    PubMed 36883093
  • Balan C, Bubenek-Turconi SI, Tomescu DR, Valeanu L. Ultrasound-Guided Regional Anesthesia-Current Strategies for Enhanced Recovery after Cardiac Surgery. Medicina (Kaunas). 2021 Mar 25;57(4):312. doi: 10.3390/medicina57040312.

    PubMed 33806175
  • Kelava M, Alfirevic A, Bustamante S, Hargrave J, Marciniak D. Regional Anesthesia in Cardiac Surgery: An Overview of Fascial Plane Chest Wall Blocks. Anesth Analg. 2020 Jul;131(1):127-135. doi: 10.1213/ANE.0000000000004682.

    PubMed 32032103
  • Kleiman AM, Sanders DT, Nemergut EC, Huffmyer JL. Chronic Poststernotomy Pain: Incidence, Risk Factors, Treatment, Prevention, and the Anesthesiologist's Role. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):698-708. doi: 10.1097/AAP.0000000000000663.

    PubMed 28937533
  • Hamilton C, Alfille P, Mountjoy J, Bao X. Regional anesthesia and acute perioperative pain management in thoracic surgery: a narrative review. J Thorac Dis. 2022 Jun;14(6):2276-2296. doi: 10.21037/jtd-21-1740.

    PubMed 35813725

Questions about this trial

What is this clinical trial studying?

A study testing Transversus Thoracic Plane Block, Transversus Thoracic Plane (TTP) Block and Conventional Systemic Analgesia in people with Postoperative Pain Following Coronary Artery Bypass Grafting (CABG), 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 4 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 22 Jun 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?

Accumulated from time of tracheal extubation through 48 hours post-extubation (time frame: rom time of tracheal extubation until administration of first rescue IV morphine dose for NRS ≥ 4, assessed up to 48 hours post-extubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07658521, which also lists 8 linked publications.

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 22 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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