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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Acute Pain; Patient Controlled Analgesia; Thoracic Surgery, Video Assisted; Postoperative Pain After Thoracic Surgery
• Intervention / Treatment: Drug: Fentanyl IV PCA; Drug: Tramadol IV PCA; Drug: Ibuprofen IV PCA

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.

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Baris Turunc, MD; Phone Number: +90 5300202777; Email: baris.turunc94@gmail.com
• Study Contact Backup: Name: Dilek Unal, MD, Prof.; Phone Number: +90 5336957855; Email: dilekunalmd@gmail.com

Study Locations

• Turkey (Türkiye)
  • Keçiören
    • Ankara, Keçiören, Turkey (Türkiye), 06010
      • Ankara Etlik City Hospital, Department of Anesthesiology and Reanimation
      • Contact: Baris Turunc, MD; Phone Number: +90 5300202777; Email: baris.turunc94@gmail.com
      • Contact: Dilek Unal, MD, Prof.; Phone Number: +90 5336957855; Email: dilekunalmd@gmail.com
      • Principal Investigator: Dilek Unal, MD, Prof.
      • Sub-Investigator: Baris Turunc, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group F (Fentanyl Group); Patients in this group are assigned to receive intravenous (IV) Patient-Controlled Analgesia (PCA) using a fentanyl solution. The treatment is initiated either at the 6th postoperative hour or upon the first request for analgesia (VAS >4). This arm is the potent opioid-based treatment group.	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
Experimental: Group T (Tramadol Group); Patients in this group are assigned to receive IV PCA using a tramadol solution. Similar to Group F, the protocol is initiated at the 6th postoperative hour or at the first analgesic demand. This arm represents the weak opioid-based approach.	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
Experimental: Group I (Ibuprofen Group); Patients in this group are assigned to receive IV PCA using an ibuprofen solution. Similar to Group F and T, the protocol is initiated at the 6th postoperative hour or at the first analgesic demand. This arm is the non-opioid, NSAID-based treatment group.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Intensity (VAS)	Evaluation of postoperative pain levels using the Visual Analog Scale (VAS). Both static (at rest) and dynamic (during coughing) VAS scores are recorded to assess the quality of analgesia. The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". Higher scores indicate worse pain.	Postoperative 6, 12, 18, 24, 36, 48, 60, and 72 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Maximal Inspiratory Volume (ml)	Assessment of respiratory effort and lung expansion using an incentive spirometer. Patients' maximum volume reached (ml) is recorded at each visit as a marker of pulmonary function and performance.	Postoperative 6, 12, 18, 24, 36, 48, 60, and 72 hours.
Rescue Analgesic Requirement	Total amount of rescue analgesics required by patients when the assigned PCA regimen is insufficient to maintain a Visual Analog Scale (VAS) score of <4. The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". Higher scores indicate worse pain.	Postoperative 6, 12, 18, 24, 36, 48, 60, and 72 hours.
Length of Hospital and ICU Stay	Duration of stay in the Intensive Care Unit (ICU) and the total length of hospital stay (days) from surgery to discharge.	From surgery until the date of hospital discharge, assessed up to 30 days.
Incidence of Postoperative Side Effects	Recording the incidence and severity of IV PCA related side effects, including nausea, vomiting, sedation, pruritus, and respiratory depression.	Up to 72 hours postoperatively.

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital
• Investigators: Principal Investigator: Dilek Unal, MD, Prof., University of Health Sciences, Ankara Etlik City Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): September 27, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: PCA; VATS; Incentive spirometry; Rebound Pain; Erector Spinae Plane Block; Opioid-sparing; ESP; Video-Assisted Thoracoscopic Surgery; Patient-Controlled Analgesia; IV analgesia; Postoperative pain after thoracic surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: AEŞH-EK-2025-181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data collected during the study are considered confidential institutional data according to the study protocol and informed consent forms approved by the local ethics committee. The data will only be available to authorized regulatory bodies and the investigation team to ensure participant privacy and data security.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No