Comparison of IV Analgesia Protocols After the Regional Block's Effect Diminishes in Thoracic Surgery

Official title

Comparison of the Effectiveness of Intravenous Analgesia Protocols Used After the Duration of Block Action for Postoperative Pain Control in Thoracic Surgery

Overview

The purpose of this study is to compare the effectiveness of three different intravenous (IV) patient-controlled analgesia (PCA) regimens-Fentanyl, Tramadol, and Ibuprofen-in managing postoperative pain and respiratory performance in patients undergoing Video-Assisted Thoracoscopic Surgery (VATS). While regional blocks like Erector Spinae Plane (ESP) block provide effective early analgesia, their effect typically diminishes after 8-12 hours, leading to potential 'rebound pain.' This study specifically investigates the period following the duration of the regional block's action. The primary goal is to evaluate which IV PCA protocol better controls pain (Visual Analog Scale scores) and supports better respiratory performance (measured by incentive spirometry) during the first 72 hours post-surgery

Detailed description

Thoracic surgery is associated with one of the highest incidences of both acute and chronic postoperative pain. Clinical evidence indicates that poorly controlled acute pain in the immediate postoperative period is a primary risk factor for the development of chronic neuropathic pain (post-thoracotomy pain syndrome). Furthermore, severe acute pain triggers a guarding reflex, leading to shallow breathing, impaired coughing, and ultimately compression atelectasis.

In alignment with the 2026 American Society of Anesthesiologists (ASA) guidelines, this study emphasizes a multimodal, opioid-sparing approach to optimize patient recovery. While regional techniques like the Erector Spinae Plane (ESP) block offer effective early analgesia, their effectiveness is typically limited to 8-12 hours. This study evaluates the effectiveness of three different IV Patient-Controlled Analgesia (PCA) regimens initiated specifically to bridge the analgesic gap after the regional block's effect diminishes.

Interventions:

All patients receive a standardized ultrasound-guided ESP block (20 ml 0.25% bupivacaine) at the end of surgery. PCA regimens (Fentanyl, Tramadol, or Ibuprofen) are initiated at the 6th postoperative hour (or earlier on patient demand). Postoperative static and dynamic pain scores (VAS), rescue analgesic requirements and respiratory performance (incentive spirometry volumes) are monitored for 72 hours.

The study hypothesizes that the Ibuprofen-based PCA will maintain comparable analgesia to opioid-based regimens while significantly improving respiratory performance by avoiding opioid-induced respiratory depression.

Study Design and Blinding:

This is a prospective, randomized, single-center trial. Patients are assigned to one of three intervention arms using a centralized randomization system with the sealed envelope method (1:1:1 ratio). The study follows a double-blind (participant and outcomes assessor) protocol. While the primary investigator manages the PCA devices, the patients and the researchers recording the visual analog scale (VAS) scores and incentive spirometry volumes are blinded to the group assignments.

Interventions

• Drug Fentanyl IV PCA
  Patients receive intravenous Patient-Controlled Analgesia (PCA) using a fentanyl solution (4 mcg/ml), initiated at the 6th postoperative hour (or earlier if VAS \>4) and continued for 72 hours. Basal infusion rate: 0.2 μg/kg/h Demand bolus dose: 20 μg Lockout interval: 20 minutes
• Drug Tramadol IV PCA
  Patients receive intravenous PCA using a tramadol solution (2 mg/ml), initiated at the 6th postoperative hour (or earlier if VAS \>4) and continued for 72 hours. Basal infusion rate: 10 mg/h Demand bolus dose: 10 mg Lockout interval: 20 minutes
• Drug Ibuprofen IV PCA
  Patients receive intravenous PCA using an ibuprofen solution (2 mg/ml), initiated at the 6th postoperative hour (or earlier if VAS \>4) and continued for 72 hours. Basal infusion rate: 20 mg/h Demand bolus dose: 10 mg Lockout interval: 20 minutes

Primary outcome measures

• Postoperative Pain Intensity (VAS) [Time frame: Postoperative 6, 12, 18, 24, 36, 48, 60, and 72 hours.]

Secondary outcome measures (4)

• Postoperative Maximal Inspiratory Volume (ml) [Time frame: Postoperative 6, 12, 18, 24, 36, 48, 60, and 72 hours.]
• Rescue Analgesic Requirement [Time frame: Postoperative 6, 12, 18, 24, 36, 48, 60, and 72 hours.]
• Length of Hospital and ICU Stay [Time frame: From surgery until the date of hospital discharge, assessed up to 30 days.]
• Incidence of Postoperative Side Effects [Time frame: Up to 72 hours postoperatively.]

Eligibility criteria

Inclusion criteria

• \- Patients aged 18 to 80 years.
• \- ASA (American Society of Anesthesiologists) Physical Status Score of I-III.
• \- Body Mass Index (BMI) between 18 and 35 kg/m².
• \- Undergoing elective thoracic surgery via Video-Assisted Thoracoscopic Surgery (VATS).
• \- Voluntary participation confirmed by signing the written Informed Consent Form.

Exclusion criteria

• \- Age below 18 or above 80 years.
• \- Advanced organ failure (e.g., severe hepatic or renal impairment).
• \- ASA physical status > III.
• \- History of chronic pain treatment or long-term opioid use.
• \- BMI < 18 kg/m² or > 35 kg/m².
• \- Pregnancy or breastfeeding.
• \- Limited cooperation due to dementia or uncontrolled psychiatric disorders.
• \- Communication barriers (inability to communicate in the native language).
• \- History of substance or drug abuse.
• \- Known allergy or contraindication to the study drugs (Fentanyl, Tramadol, or Ibuprofen).
• \- Contraindication to regional block placement (e.g., infection at the injection site).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Ankara Etlik City Hospital, Department of Anesthesiology and Reanimation — Ankara

Publications

• Feray S, Lubach J, Joshi GP, Bonnet F, Van de Velde M; PROSPECT Working Group *of the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guidelines for video-assisted thoracoscopic surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2022 Mar;77(3):311-325. doi: 10.1111/anae.15609. Epub 2021 Nov 5. PMID 34739134
• Mitchell J, Couvreur C, Forget P. Recent Advances in Perioperative Analgesia in Thoracic Surgery: A Narrative Review. J Clin Med. 2024 Dec 25;14(1):38. doi: 10.3390/jcm14010038. PMID 39797121
• Harris DJ, Hilliard PE, Jewell ES, Brummett CM. The association between incentive spirometry performance and pain in postoperative thoracic epidural analgesia. Reg Anesth Pain Med. 2015 May-Jun;40(3):232-8. doi: 10.1097/AAP.0000000000000239. PMID 25899952
• Sun JJ, Xiang XB, Xu GH, Cheng XQ. A Novel Opioid-Sparing Analgesia Following Thoracoscopic Surgery: A Non-Inferiority Trial. Drug Des Devel Ther. 2023 Jun 6;17:1641-1650. doi: 10.2147/DDDT.S405990. eCollection 2023. PMID 37305403
• Yu H, Tian W, Xu Z, Jiang R, Jin L, Mao W, Chen Y, Yu H. Patient-controlled intravenous analgesia with opioids after thoracoscopic lung surgery: a randomized clinical trial. BMC Anesthesiol. 2022 Aug 8;22(1):253. doi: 10.1186/s12871-022-01785-4. PMID 35941536

Identifiers

NCT: NCT07610408 · AEŞH-EK-2025-181

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗