Continue ESPB & Continue ESPB Combined With SAPB for Thoracotomy

NCT06685445 | Completed

• 1 other identifier: Bursa City Hospital 10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who have undergone thoracotomy experience severe pain in the postoperative period. This pain leads to many complications. Erector spinae plane block (ESPB) and Serratus anterior plane block (SAPB) are alternative methods to thoracic epidural block (TEB) that provide analgesia in thoracic pain. The application of both blocks and the nerves they affect are different. The aim of this study is to compare the analgesic efficacy of the combination of ESPB and SAP against ESPB in patients who have undergone thoracotomy

Conditions

Post-thoracotomy Pain

Keywords

Thoracotomy; Postoperative Analgesia; Continous Erector Spinae Block; Serratus Anterior Block

Outcome Measures

Primary Outcomes (1)

• Postoperative pain scores

  Pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable") during postoperative 72 hours period. Active NRS (when moving, coughing,) Passive NRS (Inactivity) Active and passive NRS scores of both groups of participants will be questioned at 1, 2, 4, 6, 12, 24, 48 and 72. hours. NRS scores between both groups will be compared

  at the first 72 hours period postoperatively

Secondary Outcomes (2)

• Opioid consumption

  Postoperative between 0-4, 4-8, 8-24, 24-48 and 48-72. hours intervals

• Requirement for rescue analgesics

  Postoperative 72 hours

Study Arms (2)

Group EPSB (Continue Erector Spinae Plane Block)

ACTIVE COMPARATOR

Following induction of anesthesia, ESPB will be performed with 30 ml of 0.25% bupivacaine (Marcaine®) and a catheter will be placed before the start of surgery. 15 ml of 0.125% bupivacaine solution will be administered through the ESPB catheter at 12-hour intervals following the end of surgery. All participants will be attached to a patient-controlled analgesia (PCA) device prepared with 5 mg/ml tramadol (Contramal®) as soon as they are admitted to the recovery room. PCA will be non-infusion, with a lockout period of 20 minutes and a bolus dose of 10 mg. In the postoperative period, 1 g paracetamol (Parol®) will be administered intravenously every 8 hours, 75 mg diclofenac (Dikloron®) intramuscularly if NRS≥4 and 0.5 mg/kg meperidine (Aldolan®) intravenously if NRS≥4 is still present after 2 hours.

Drug: Active Comparator: Continue Erector Spinae Plane Block

Group ESPB+SAPB (Continue Erector Spinae Plane Block + Serratus Anterior Plane Block)

ACTIVE COMPARATOR

Following induction of anesthesia, ESPB with 30 ml of 0.25% bupivacaine (Marcaine®) will be performed and the catheter will be placed before the surgery starts. After the end of surgery, SAPB with 30 ml of 0.25% bupivacaine will be performed before extubation. Following the end of the surgery, 15 ml of 0.125% bupivacaine solution will be administered through the ESPB catheter at 12-hour intervals. All participants will be attached to a patient-controlled analgesia device prepared with 5 mg/ml tramadol (Contramal®) as soon as they are admitted to the recovery room. There will be no infusion in PCA, 20 minutes lock time, 10 mg bolus dose. In the postoperative period, 1 g paracetamol (Parol®) will be administered intravenously every 8 hours, 75 mg intramuscular diclofenac (Dikloron®) if NRS≥ 4 and 0.5 mg/kg meperidine (Aldolan®) intravenously if NRS≥ 4 is still present after 2 hours.

Drug: Active Comparator: Continue Erector Spinae Plane Block + Serratus Anterior Plane Block

Interventions

Active Comparator: Continue Erector Spinae Plane Block DRUG

For the block, the ultrasound (USG)probe will be placed longitudinally 2-3 cm lateral to the transverse process of the T4-5 vertebra. The erector spinae muscle will be visualized above the hyperechoic transverse process. Using in plane technique, the block needle will be advanced in the cranio-caudal direction and 5 ml of saline will be injected under the erector spinae muscle to confirm the block site. After the block site is confirmed, 30 ml of 0.25% bupivacaine (Marcain 0.5%® AstraZeneca, England) will be administered. The block catheter (Perifix® Braun, Germany) will then be inserted to block area

Also known as: Postoperative analgesia management

Group EPSB (Continue Erector Spinae Plane Block)

Active Comparator: Continue Erector Spinae Plane Block + Serratus Anterior Plane Block DRUG

For ESPB, USG probe will be placed longitudinally 2-3 cm lateral to the transverse process of the T4-5 vertebra. The erector spinae muscle will be visualized above the hyperechoic transverse process. Using in plane technique, the block needle will be advanced in the cranio-caudal direction and 5 ml of saline will be injected under the erector spinae muscle to confirm the block site and 30 ml of 0.25% bupivacaine (Marcain®) will be administered. The block catheter (Perifix®) will be inserted. For SAPB, the USG probe will be placed parasagittal to the mid-axillary line at the 5th-6th rib level and the anechoic shadow of the costa together with the latissumus dorsi and serratus anterior muscles will be visualized. Then using in plane technique, the block needle will be advanced in the cranio-caudal direction and 5 ml of saline will be injected under the serratus anterior muscle and the block site will be confirmed and 30 ml of 0.25% bupivacaine will be administered.

Also known as: Postoperative analgesia management

Group ESPB+SAPB (Continue Erector Spinae Plane Block + Serratus Anterior Plane Block)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ASA classification I-III
• Aged 18-80 years
• Who will be scheduled for thoracotomy

You may not qualify if:

• Those with psychiatric-neurological diseases that may affect pain perception
• Regular users of antipsychotics, antidepressants
• Allergic to any of the drugs specified in the protocol
• Presence of contraindications to regional anesthesia (infection at the site of the block, bleeding diathesis, etc.)

Sponsors & Collaborators

• Bursa City Hospital: lead

Study Sites (1)

Bursa City Hospital

Bursa, 16000, Turkey (Türkiye)

Location

Related Publications (6)

• Deng B, Qian K, Zhou JH, Tan QY, Wang RW. Optimization of Chest Tube Management to Expedite Rehabilitation of Lung Cancer Patients After Video-Assisted Thoracic Surgery: A Meta-Analysis and Systematic Review. World J Surg. 2017 Aug;41(8):2039-2045. doi: 10.1007/s00268-017-3975-x.

  PMID: 28289835 BACKGROUND

• Nagahiro I, Andou A, Aoe M, Sano Y, Date H, Shimizu N. Pulmonary function, postoperative pain, and serum cytokine level after lobectomy: a comparison of VATS and conventional procedure. Ann Thorac Surg. 2001 Aug;72(2):362-5. doi: 10.1016/s0003-4975(01)02804-1.

  PMID: 11515867 BACKGROUND

• Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

  PMID: 23923989 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Savage C, McQuitty C, Wang D, Zwischenberger JB. Postthoracotomy pain management. Chest Surg Clin N Am. 2002 May;12(2):251-63. doi: 10.1016/s1052-3359(02)00011-x.

  PMID: 12122825 BACKGROUND

• Toscano A, Capuano P, Costamagna A, Canavosio FG, Ferrero D, Alessandrini EM, Giunta M, Rinaldi M, Brazzi L. Is continuous Erector Spinae Plane Block (ESPB) better than continuous Serratus Anterior Plane Block (SAPB) for mitral valve surgery via mini-thoracotomy? Results from a prospective observational study. Ann Card Anaesth. 2022 Jul-Sep;25(3):286-292. doi: 10.4103/aca.aca_69_21.

  PMID: 35799555 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc prof

Model Details: There are two models for this study. Continous Erector Spinae Block (Group ESPB) group, and Serratus Anterior Plane Block + Continous Erector Spinae Block (Group ESPB+SAPB) group

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: October 18, 2024
• Primary Completion: February 10, 2025
• Study Completion: March 1, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

TU (1)