Acute Pain, Patient Controlled Analgesia, Postoperative Pain, Postoperative Pain After Thoracic Surgery, Thoracic Surgery, Video Assisted
Conditions
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
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
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
DRUGFentanyl 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
DRUGTramadol 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
DRUGIbuprofen 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
Sponsors
Ankara Etlik City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity (VAS) | Postoperative 6, 12, 18, 24, 36, 48, 60, and 72 hours. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Maximal Inspiratory Volume (ml) | Postoperative 6, 12, 18, 24, 36, 48, 60, and 72 hours. | 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. |
| Rescue Analgesic Requirement | Postoperative 6, 12, 18, 24, 36, 48, 60, and 72 hours. | 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. |
| Length of Hospital and ICU Stay | From surgery until the date of hospital discharge, assessed up to 30 days. | Duration of stay in the Intensive Care Unit (ICU) and the total length of hospital stay (days) from surgery to discharge. |
| Incidence of Postoperative Side Effects | Up to 72 hours postoperatively. | Recording the incidence and severity of IV PCA related side effects, including nausea, vomiting, sedation, pruritus, and respiratory depression. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBaris Turunc, MD
CONTACTDilek Unal, MD, Prof.
PRINCIPAL_INVESTIGATORDilek Unal, MD, Prof.
University of Health Sciences, Ankara Etlik City Hospital
Outcome results
None listed