Combined SPSP and TTP Blocks for Postoperative Analgesia Post-CABG

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура Transversus Thoracic Plane Block
  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.
• Процедура Transversus Thoracic Plane (TTP) Block
  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.
• Препарат Conventional Systemic Analgesia
  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 backgroun
• Препарат 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)

Первичные конечные точки

• Accumulated from time of tracheal extubation through 48 hours post-extubation [Срок оценки: rom time of tracheal extubation until administration of first rescue IV morphine dose for NRS ≥ 4, assessed up to 48 hours post-extubation]

Вторичные конечные точки (12)

• NRS pain score at rest [Срок оценки: Assessed at extubation (0 h), 6 hours, 12 hours, 24 hours, and 48 hours post-extubation]
• NRS pain score on movement/coughing [Срок оценки: Assessed at extubation (0 h), 6 hours, 12 hours, 24 hours, and 48 hours post-extubation]
• Time to first rescue analgesic [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Assessed at 6 hours and 24 hours post-extubation]
• Incidence of atelectasis [Срок оценки: From time of tracheal extubation until hospital discharge or postoperative day 30, whichever occurs first]
• Incentive spirometry volume [Срок оценки: Assessed at 24 hours and 48 hours post-extubation]
• Pulmonary complications [Срок оценки: From time of tracheal extubation until hospital discharge or postoperative day 30, whichever occurs first]
• Intensive care unit length of stay [Срок оценки: From ICU admission until ICU discharge, assessed up to 7 days postoperatively]
• Hospital length of stay [Срок оценки: From date of surgery until date of hospital discharge, assessed up to 30 days postoperatively]
• Patient satisfaction with pain management [Срок оценки: Assessed at 48 hours post-extubation using a 5-point Likert scale]
• Time to first ambulation [Срок оценки: 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]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Ain Shams University Hospitals — Cairo

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07658521 · FAMSU R30/2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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