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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baris Turunc, MD | Contact | +90 5300202777 | baris.turunc94@gmail.com | |
| Dilek Unal, MD, Prof. | Contact | +90 5336957855 | dilekunalmd@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dilek Unal, MD, Prof. | University of Health Sciences, Ankara Etlik City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital, Department of Anesthesiology and Reanimation | Recruiting | Ankara | Keçiören | 06010 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34739134 | Background | 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. | |
| 39797121 |
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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.
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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.
|
| 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 |
|
| 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 |
|
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. |
| 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. |
| 25899952 | 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. |
| 37305403 | 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. |
| 35941536 | 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. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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