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

NCT07610408 | Recruiting

• 1 other identifier: AEŞH-EK-2025-181
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patient Controlled Analgesia; Postoperative Pain After Thoracic Surgery; Postoperative Pain; Thoracic Surgery, Video Assisted; Acute Pain

Keywords

Video-Assisted Thoracoscopic Surgery; VATS; Erector Spinae Plane Block; ESP; Patient-Controlled Analgesia; PCA; IV analgesia; Incentive spirometry; Opioid-sparing; Postoperative pain after thoracic surgery; Rebound Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Postoperative Maximal Inspiratory Volume (ml)

  Postoperative 6, 12, 18, 24, 36, 48, 60, and 72 hours.

• Rescue Analgesic Requirement

  Postoperative 6, 12, 18, 24, 36, 48, 60, and 72 hours.

• Length of Hospital and ICU Stay

  From surgery until the date of hospital discharge, assessed up to 30 days.

• Incidence of Postoperative Side Effects

  Up to 72 hours postoperatively.

Study Arms (3)

Group F (Fentanyl Group)

EXPERIMENTAL

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

Group T (Tramadol Group)

EXPERIMENTAL

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

Group I (Ibuprofen Group)

EXPERIMENTAL

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

Interventions

Fentanyl IV PCA DRUG

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

Group F (Fentanyl Group)

Tramadol IV PCA DRUG

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

Group T (Tramadol Group)

Ibuprofen IV PCA DRUG

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

Group I (Ibuprofen Group)

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 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.

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital, Department of Anesthesiology and Reanimation

Ankara, Keçiören, 06010, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Dilek Unal, MD, Prof.

  University of Health Sciences, Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baris Turunc, MD

CONTACT

+90 5300202777; baris.turunc94@gmail.com

Dilek Unal, MD, Prof.

CONTACT

+90 5336957855; dilekunalmd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: While the primary investigator responsible for the administration and adjustment of the Patient-Controlled Analgesia (PCA) devices was aware of the group assignments, the patients were blinded to the specific drug they received. Furthermore, the researchers who recorded the Visual Analog Scale (VAS) scores and measured the incentive spirometry volumes at each visit were blinded to the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 28, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): September 27, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)