Combined SPSP and TTP Blocks for Postoperative Analgesia Post-CABG

NCT07658521 | Enrolling By Invitation DMC

• 1 other identifier: FAMSU R30/2026
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Conditions

Postoperative Pain Following Coronary Artery Bypass Grafting (CABG)

Keywords

CABG; Postoperative pain; Serratus posterior superior plane block; Transversus thoracic plane block; Ultrasound-guided nerve block; Cardiac surgery

Outcome Measures

Primary Outcomes (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.

  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

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

• NRS pain score on movement/coughing

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

• Time to first rescue analgesic

  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

  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)

  Assessed at 6 hours and 24 hours post-extubation

Other Outcomes (3)

• Block-related complications

  From performance of regional blocks until hospital discharge or postoperative day 30, whichever occurs first.

• Local anesthetic systemic toxicity

  From initiation of regional block injection until 24 hours post-block.

• Opioid-related adverse events

  From time of tracheal extubation through hospital discharge or postoperative day 30, whichever occurs first.

Study Arms (2)

Combined SPSP + TTP Block

EXPERIMENTAL

Participants receive bilateral ultrasound-guided serratus posterior superior (SPSP) plane block and bilateral transversus thoracic plane (TTP) block.

Procedure: Transversus Thoracic Plane Block; Procedure: Transversus Thoracic Plane (TTP) Block; 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.

Drug: Conventional Systemic Analgesia

Interventions

Transversus Thoracic Plane Block PROCEDURE

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.

Combined SPSP + TTP Block

Transversus Thoracic Plane (TTP) Block PROCEDURE

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.

Combined SPSP + TTP Block

Conventional Systemic Analgesia DRUG

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).

Combined SPSP + TTP Block; Conventional Analgesia Group

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)

Combined SPSP + TTP Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, 1181, Egypt

Location

Related Publications (8)

• 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.

  PMID: 34803399 BACKGROUND

• 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.

  PMID: 27093277 BACKGROUND

• 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.

  PMID: 26897453 BACKGROUND

• 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.

  PMID: 36883093 BACKGROUND

• 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.

  PMID: 33806175 BACKGROUND

• 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.

  PMID: 32032103 BACKGROUND

• 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.

  PMID: 28937533 BACKGROUND

• 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.

  PMID: 35813725 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

thiamine triphosphorate; Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Nasser Elsayed Ebrahim, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a patient- and outcome-assessor-blinded trial. Participants are blinded because all receive identically labelled "study injection" syringes and are under general anesthesia during block performance. Outcome assessors (ICU nurses, data collectors, and statisticians) are blinded to group allocation and access only coded data. The block-performing anesthesiologist is the only unblinded individual. This person is considered both a care provider and an investigator and is therefore excluded from masking for those roles. The block performer is not involved in postoperative care, outcome assessment, or data analysis, per CONSORT 2010 guidelines for interventional trials where complete blinding of the performer is not feasible. All other anesthesiologists, surgeons, and ICU staff are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Access Criteria: Data will be available beginning 9 months after primary publication and ending 36 months thereafter.

Locations

EG (1)