Postoperative Pain Following Coronary Artery Bypass Grafting (CABG)PACTNCT07658521
Combined SPSP and TTP Blocks for Postoperative Analgesia Post-CABG
A study testing Bilateral Posterior Superior Plane Block, Bilateral Transversus Thoracic Plane 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.
Trial summary
After heart bypass surgery (coronary artery bypass grafting, CABG), the breastbone is divided to reach the heart, which causes significant pain. Pain can make deep breathing and coughing difficult and may slow recovery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain Following Coronary Artery Bypass Grafting (CABG)
- What is being tested?
- Bilateral Posterior Superior Plane Block, Bilateral Transversus Thoracic Plane and Conventional Systemic Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 30 Sep 2026
- 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 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.
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
After heart bypass surgery (coronary artery bypass grafting, CABG), the breastbone is divided to reach the heart, which causes significant pain. Pain can make deep breathing and coughing difficult and may slow recovery. Strong pain medicines called opioids are the usual treatment, but they can cause side effects such as drowsiness, slowed breathing, nausea, vomiting, and confusion.
This study tested whether two nerve blocks given together can reduce the need for opioids after bypass surgery. A nerve block is an injection of local anesthetic, guided by ultrasound, that numbs a specific area of the body. The two blocks are the serratus posterior superior plane (SPSP) block, which numbs the upper side and back of the chest wall, and the transversus thoracic plane (TTP) block, which numbs the front of the chest next to the breastbone. Both were placed on each side of the chest after the patient was asleep under general anesthesia and before surgery began.
Read more
Adults aged 18 to 75 having planned (non-emergency) bypass surgery were randomly assigned, by chance, to one of two groups. One group received both blocks plus standard pain medicines. The other group received standard pain medicines alone. Patients did not know which group they were in, and the staff who measured outcomes were also unaware of group assignment.
The main question was how much opioid medicine patients needed in the first 48 hours after the breathing tube was removed. Other measures included pain scores at rest and with movement, time until first rescue pain medicine, time to breathing-tube removal, oxygen levels, length of ICU and hospital stay, time to first getting out of bed, patient satisfaction, and side effects such as complications from the blocks or from opioids.
The results may help doctors decide whether combining these two blocks is a useful way to control pain and reduce opioid use after heart bypass surgery.
Read the detailed description
Rationale. Opioid-centered analgesia after CABG delays recovery, and thoracic epidural analgesia is generally avoided in patients who are fully anticoagulated. The SPSP block covers the lateral and posterior chest wall, and the TTP block covers the anterior parasternal region. Their combined use had not been evaluated in a prospective randomized trial in cardiac surgery.
Hypothesis. Combined bilateral SPSP and TTP blocks lower 48-hour postoperative opioid consumption compared with standardized systemic analgesia alone in elective isolated CABG.
Design. Single-center, prospective, parallel-group, superiority randomized controlled trial with 1:1 allocation. Randomization used a computer-generated permuted block sequence (block sizes 4 and 6) prepared by a statistician not involved in care. Allocation was concealed with sequentially numbered, opaque, sealed envelopes, opened after induction of anesthesia.
Blinding. Patients (blocks were placed under general anesthesia) and all outcome assessors were blinded. The performing anesthesiologist could not be blinded and took no part in postoperative care, outcome assessment, data collection or analysis. Study syringes were labeled "Study Injection". Local wound infiltration was prohibited in both groups, and compliance was checked against anesthesia and nursing records. No sham procedure was used.
Standardization. Intraoperative and postoperative analgesia followed one protocol in both groups, including rescue criteria and conversion of all opioids to morphine milligram equivalents (MME). Intraoperative opioid doses were recorded separately and excluded from the primary outcome.
Block success. Assessed once, after extubation, by a blinded assessor using cold and pinprick testing over the expected dermatomes. Success rates were reported descriptively and defined the per-protocol population.
Safety monitoring. Resuscitation equipment and lipid emulsion were available at the bedside, with continuous ECG, arterial pressure, and SpO₂ monitoring. Block sites were inspected at 30 min, 6 h, and 24 h, and lung ultrasound was used for new desaturation or respiratory distress.
Statistical analysis. Intention-to-treat was primary. The primary outcome was compared with the Mann-Whitney U test (Hodges-Lehmann estimate with 95% CI), with ANCOVA adjusted for intraoperative opioid consumption as a sensitivity analysis. Secondary outcomes were prespecified, not powered, and considered hypothesis-generating.
Sample size. The target of 100 (50 per group) was set before enrollment, exceeding the originally calculated 88, to allow for block failure and to improve precision of secondary estimates.
Reporting. CONSORT 2025.
- Being tested
- Bilateral Posterior Superior Plane Block, Bilateral Transversus Thoracic Plane, Conventional Systemic Analgesia, Bupivacaine 0.25%
- Keywords
- Coronary Artery Bypass, Nerve Block, Pain, Postoperative, Analgesics, Opioid, Enhanced Recovery After Surgery, Thoracic Wall
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Posterior Superior Plane BlockProcedure or surgery
With the patient in slight lateral tilt (15-20°), the trapezius (superficial), rhomboid major/minor, and the fascial plane deep to the rhomboids overlying the serratus posterior superior muscle at T2 to T5 were identified. Using a 22-gauge, 50-80 mm echogenic needle (Stimuplex Ultra 360, B. Braun) and an in-plane lateral-to-medial approach, after negative aspiration and a 1 mL test dose, 15 mL of 0.25% bupivacaine per side was deposited incrementally, confirming fascial spread under continuous ultrasound guidance. The procedure was repeated on the contralateral side.
Bilateral Transversus Thoracic PlaneProcedure or surgery
With the patient supine, a parasternal short-axis scan was performed at the second-fourth intercostal space level. The pectoralis major (superficial), internal intercostal muscle, and transversus thoracic muscle (deep) were identified. Using a 22-gauge, 50-80 mm echogenic block needle (Stimuplex Ultra 360, B. Braun) and an in-plane approach, after negative aspiration and a 1 mL test dose, 15 mL of 0.25% bupivacaine per side was deposited in 3-5 mL increments with intermittent aspiration, confirming fascial spread (downward displacement of the pleura). The procedure was repeated on the contralateral side.
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: paracetamol 1 g every 6 hours from ICU arrival. A continuous intravenous fentanyl infusion commenced at 0.5 μg/kg/h once the patient emerged from anesthesia and NRS assessment became feasible. The fentanyl infusion weaned by 25% every hour prior to planned extubation and discontinued at extubation. Intravenous morphine was administered in incremental doses of 2-3 mg every 10 minutes when the NRS score was ≥4, with repeated doses until satisfactory analgesia (NRS ≤3) was achieved. Additional rescue doses of 1-2 mg were provided as required based on subsequent pain assessments.
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 group | Role | What they receive |
|---|---|---|
| Combined SPSP + TTP Block | Experimental | Participants receive bilateral ultrasound-guided serratus posterior superior (SPSP) plane block and bilateral transversus thoracic plane (TTP) block. Receives: Procedure: Bilateral Posterior Superior Plane Block; Procedure: Bilateral Transversus Thoracic Plane; Drug: Conventional Systemic Analgesia; Drug: Bupivacaine 0.25% |
| Conventional Analgesia Group | Active comparator | Participants 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.
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)
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
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
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
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
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
Incidence of atelectasis
incidence of atelectasis (radiographic confirmation)
Measured: From time of tracheal extubation until hospital discharge or postoperative day 30, whichever occurs first
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
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
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
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
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
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.
- First posted22 Jun 2026
- Study start1 Jul 2026
- Primary completion25 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain Following Coronary Artery Bypass Grafting (CABG)Studies 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
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Alaaeldin Alhadidy, Ain Shams University
- Investigators
- Nasser Elsayed Ebrahim, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658521
- Sponsor's protocol ID
- FAMSU R30/2026
- Acronym
- PACT
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2026
- Last updated
- 2 Nov 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 34803399Murata 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 27093277Ueshima 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 26897453Tulgar 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 36883093Balan 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 33806175Kelava 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 32032103Kleiman 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 28937533Hamilton 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07658521
- Acronym / sponsor ID
- PACT / FAMSU R30/2026
- Keywords
- Coronary Artery Bypass, Nerve Block, Pain, Postoperative, Analgesics, Opioid, Enhanced Recovery After Surgery, Thoracic Wall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 22 Jun 2026 (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.
After heart bypass surgery (coronary artery bypass grafting, CABG), the breastbone is divided to reach the heart, which causes significant pain. Pain can make deep breathing and coughing difficult and may slow recovery. Strong pain medicines called opioids are the usual treatment, but they can cause side effects such as drowsiness, slowed breathing, nausea, vomiting, and confusion.
This study tested whether two nerve blocks given together can reduce the need for opioids after bypass surgery. A nerve block is an injection of local anesthetic, guided by ultrasound, that numbs a specific area of the body. The two blocks are the serratus posterior superior plane (SPSP) block, which numbs the upper side and back of the chest wall, and the transversus thoracic plane (TTP) block, which numbs the front of the chest next to the breastbone. Both were placed on each side of the chest after the patient was asleep under general anesthesia and before surgery began.
Adults aged 18 to 75 having planned (non-emergency) bypass surgery were randomly assigned, by chance, to one of two groups. One group received both blocks plus standard pain medicines. The other group received standard pain medicines alone. Patients did not know which group they were in, and the staff who measured outcomes were also unaware of group assignment.
The main question was how much opioid medicine patients needed in the first 48 hours after the breathing tube was removed. Other measures included pain scores at rest and with movement, time until first rescue pain medicine, time to breathing-tube removal, oxygen levels, length of ICU and hospital stay, time to first getting out of bed, patient satisfaction, and side effects such as complications from the blocks or from opioids.
The results may help doctors decide whether combining these two blocks is a useful way to control pain and reduce opioid use after heart bypass surgery.
Detailed description
Rationale. Opioid-centered analgesia after CABG delays recovery, and thoracic epidural analgesia is generally avoided in patients who are fully anticoagulated. The SPSP block covers the lateral and posterior chest wall, and the TTP block covers the anterior parasternal region. Their combined use had not been evaluated in a prospective randomized trial in cardiac surgery.
Hypothesis. Combined bilateral SPSP and TTP blocks lower 48-hour postoperative opioid consumption compared with standardized systemic analgesia alone in elective isolated CABG.
Design. Single-center, prospective, parallel-group, superiority randomized controlled trial with 1:1 allocation. Randomization used a computer-generated permuted block sequence (block sizes 4 and 6) prepared by a statistician not involved in care. Allocation was concealed with sequentially numbered, opaque, sealed envelopes, opened after induction of anesthesia.
Blinding. Patients (blocks were placed under general anesthesia) and all outcome assessors were blinded. The performing anesthesiologist could not be blinded and took no part in postoperative care, outcome assessment, data collection or analysis. Study syringes were labeled "Study Injection". Local wound infiltration was prohibited in both groups, and compliance was checked against anesthesia and nursing records. No sham procedure was used.
Standardization. Intraoperative and postoperative analgesia followed one protocol in both groups, including rescue criteria and conversion of all opioids to morphine milligram equivalents (MME). Intraoperative opioid doses were recorded separately and excluded from the primary outcome.
Block success. Assessed once, after extubation, by a blinded assessor using cold and pinprick testing over the expected dermatomes. Success rates were reported descriptively and defined the per-protocol population.
Safety monitoring. Resuscitation equipment and lipid emulsion were available at the bedside, with continuous ECG, arterial pressure, and SpO₂ monitoring. Block sites were inspected at 30 min, 6 h, and 24 h, and lung ultrasound was used for new desaturation or respiratory distress.
Statistical analysis. Intention-to-treat was primary. The primary outcome was compared with the Mann-Whitney U test (Hodges-Lehmann estimate with 95% CI), with ANCOVA adjusted for intraoperative opioid consumption as a sensitivity analysis. Secondary outcomes were prespecified, not powered, and considered hypothesis-generating.
Sample size. The target of 100 (50 per group) was set before enrollment, exceeding the originally calculated 88, to allow for block failure and to improve precision of secondary estimates.
Reporting. CONSORT 2025.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Combined SPSP + TTP Block | Experimental | Procedure: Bilateral Posterior Superior Plane Block, Procedure: Bilateral Transversus Thoracic Plane, Drug: Conventional Systemic Analgesia, Drug: Bupivacaine 0.25%Participants receive bilateral ultrasound-guided serratus posterior superior (SPSP) plane block and bilateral transversus thoracic plane (TTP) block. |
| Conventional Analgesia Group | Active comparator | Drug: Conventional Systemic AnalgesiaParticipants receive standardized multimodal systemic analgesia alone without any regional anesthesia blocks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Bilateral Posterior Superior Plane BlockWith the patient in slight lateral tilt (15-20°), the trapezius (superficial), rhomboid major/minor, and the fascial plane deep to the rhomboids overlying the serratus posterior superior muscle at T2 to T5 were identified. Using a 22-gauge, 50-80 mm echogenic needle (Stimuplex Ultra 360, B. Braun) and an in-plane lateral-to-medial approach, after negative aspiration and a 1 mL test dose, 15 mL of 0.25% bupivacaine per side was deposited incrementally, confirming fascial spread under continuous ultrasound guidance. The procedure was repeated on the contralateral side. | Procedure or surgery | Combined SPSP + TTP Block |
| Bilateral Transversus Thoracic PlaneWith the patient supine, a parasternal short-axis scan was performed at the second-fourth intercostal space level. The pectoralis major (superficial), internal intercostal muscle, and transversus thoracic muscle (deep) were identified. Using a 22-gauge, 50-80 mm echogenic block needle (Stimuplex Ultra 360, B. Braun) and an in-plane approach, after negative aspiration and a 1 mL test dose, 15 mL of 0.25% bupivacaine per side was deposited in 3-5 mL increments with intermittent aspiration, confirming fascial spread (downward displacement of the pleura). The procedure was repeated on the contralateral side. | Procedure or surgery | Combined SPSP + TTP Block |
| Conventional Systemic AnalgesiaStandardized 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: paracetamol 1 g every 6 hours from ICU arrival. A continuous intravenous fentanyl infusion commenced at 0.5 μg/kg/h once the patient emerged from anesthesia and NRS assessment became feasible. The fentanyl infusion weaned by 25% every hour prior to planned extubation and discontinued at extubation. Intravenous morphine was administered in incremental doses of 2-3 mg every 10 minutes when the NRS score was ≥4, with repeated doses until satisfactory analgesia (NRS ≤3) was achieved. Additional rescue doses of 1-2 mg were provided as required based on subsequent pain assessments. | Drug | Combined SPSP + TTP Block, Conventional Analgesia Group |
| Bupivacaine 0.25%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) | Drug | Combined SPSP + TTP Block |
Primary outcome
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
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.
12 secondary outcomes
NRS pain score at rest
Time frame: Assessed at extubation (0 h), 6 hours, 12 hours, 24 hours, and 48 hours post-extubation
NRS pain score on movement/coughing
Time frame: Assessed at extubation (0 h), 6 hours, 12 hours, 24 hours, and 48 hours post-extubation
Time to first rescue analgesic
Time frame: From time of tracheal extubation until administration of first rescue IV morphine dose for NRS ≥ 4, assessed up to 48 hours post-extubation
Time to tracheal extubation
Time frame: From end of surgery (skin closure) until successful removal of endotracheal tube and spontaneous breathing without ventilatory support, assessed up to 48 hours
Arterial oxygenation (PaO₂/FiO₂ ratio)
Time frame: Assessed at 6 hours and 24 hours post-extubation
Incidence of atelectasis
Time frame: From time of tracheal extubation until hospital discharge or postoperative day 30, whichever occurs first
Incentive spirometry volume
Time frame: Assessed at 24 hours and 48 hours post-extubation
Pulmonary complications
Time frame: From time of tracheal extubation until hospital discharge or postoperative day 30, whichever occurs first
Intensive care unit length of stay
Time frame: From ICU admission until ICU discharge, assessed up to 7 days postoperatively
Hospital length of stay
Time frame: From date of surgery until date of hospital discharge, assessed up to 30 days postoperatively
Patient satisfaction with pain management
Time frame: Assessed at 48 hours post-extubation using a 5-point Likert scale
Time to first ambulation
Time frame: 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
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 2 Nov 2026.
- Background: PubMed 34803399Shokri 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.
- Background: PubMed 27093277Murata 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.
- Background: PubMed 26897453Ueshima 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.
- Background: PubMed 36883093Tulgar 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.
- Background: PubMed 33806175Balan 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.
- Background: PubMed 32032103Kelava 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.
- Background: PubMed 28937533Kleiman 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.
- Background: PubMed 35813725Hamilton 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.
- Individual participant dataSharing planned: 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.
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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.
Nasser Elsayed Ebrahim, MD principal investigator
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 Bilateral Posterior Superior Plane Block, Bilateral Transversus Thoracic Plane 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: finished, as of the sponsor's last update on 2 Nov 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?
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?
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 2 Nov 2026.