Postoperative Pain After Thoracic SurgeryNCT07610408
Comparison of IV Analgesia Protocols After the Regional Block's Effect Diminishes in Thoracic Surgery
A study testing Fentanyl IV PCA, Tramadol IV PCA and Ibuprofen IV PCA in people with Postoperative Pain After Thoracic Surgery and Postoperative Pain, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain After Thoracic Surgery, Postoperative Pain, Thoracic Surgery, Video Assisted
- What is being tested?
- Fentanyl IV PCA, Tramadol IV PCA and Ibuprofen IV PCA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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.
Who cannot join
- - 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.
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- - 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).
- - Intraoperative conversion to thoracotomy (as the procedure no longer met the VATS inclusion criterion; excluded before randomization)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital, Department of Anesthesiology and Reanimation
Ankara, Keçiören, 06010
About this study
Official title: 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.
Read the 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 received a standardized ultrasound-guided ESP block (20 ml 0.25% bupivacaine) at the end of surgery. PCA regimens (Fentanyl, Tramadol, or Ibuprofen) were 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 flow rates) were monitored for 72 hours.
The study hypothesizes that the Ibuprofen-based PCA will maintain comparable analgesia to opioid-based regimens while improving respiratory performance by avoiding opioid-induced respiratory depression.
Study Design and Blinding:
This was a prospective, randomized, single-center trial. Patients were randomized postoperatively, immediately before PCA initiation (at the postoperative 6th hour, or earlier if analgesia was required), to one of three intervention arms using a computer-generated randomization list (randomizer.org) with 1:1:1 allocation and equal group sizes (n=45 per group). Allocations were concealed in sequentially numbered, opaque, sealed envelopes prepared by an independent person not involved in the study. The study followed a double-blind (participant and outcomes assessor) design. Study drugs were prepared in identical 500 ml saline bags, indistinguishable in color and volume, and the PCA devices were loaded and programmed by a third anesthesiologist not involved in data collection. Patients and the investigators recording visual analog scale (VAS) scores and incentive spirometry flow rates were blinded to group assignments.
Participant flow:
Of 142 eligible patients, 2 declined participation and 5 were excluded before randomization due to intraoperative conversion to thoracotomy; 135 patients were randomized (45 per group).
Note on outcome measure terminology:
Incentive spirometry was performed with a flow-oriented device (Triflo®), which indicates inspiratory flow rate (ml/s). The respiratory outcome measure was originally described as inspiratory volume (ml); this description was corrected to inspiratory flow rate (ml/s) at study completion. The device, measurement procedure and time points were unchanged.
- Conditions
- Postoperative Pain After Thoracic Surgery, Postoperative Pain, Thoracic Surgery, Video Assisted, Patient Controlled Analgesia, Acute Pain
- Being tested
- Fentanyl IV PCA, Tramadol IV PCA, Ibuprofen IV PCA
- 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
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl IV PCADrug
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
Tramadol IV PCADrug
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 PCADrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Ibuprofen IV PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative 6, 12, 18, 24, 36, 48, 60, and 72 hours.
Secondary outcomes (4)
Postoperative Maximal Inspiratory Flow Rate (ml/s)
Inspiratory effort assessed with a flow-oriented incentive spirometer (Triflo®). In the upright sitting position, after a deep expiration, patients performed three maximal inspiratory efforts and the highest flow rate achieved (ml/s) was recorded as a marker of postoperative respiratory performance.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 72 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start2 Jun 2026
- Primary completion27 Sep 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain After Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Barış Turunç, Ankara Etlik City Hospital
- Investigators
- Dilek Unal, MD, Prof., Principal investigator, University of Health Sciences, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610408
- Sponsor's protocol ID
- AEŞH-EK-2025-181
- Status last verified
- Oct 2026
- First submitted
- 14 May 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 34739134Mitchell 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.
PubMed 39797121Harris 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.
PubMed 25899952Sun 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.
PubMed 37305403Yu 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.
PubMed 35941536
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Intravenous Analgesia Protocols Used After the Duration of Block Action for Postoperative Pain Control in Thoracic Surgery
- ClinicalTrials.gov ID
- NCT07610408
- Acronym / sponsor ID
- AEŞH-EK-2025-181
- Conditions
- Postoperative Pain After Thoracic Surgery, Postoperative Pain, Thoracic Surgery, Video Assisted, Patient Controlled Analgesia, Acute Pain
- Keywords
- Video-Assisted Thoracoscopic Surgery, VATS, Erector Spinae Plane Block, ESP, Patient-Controlled Analgesia, PCA, IV analgesia, Incentive spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 27 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 received a standardized ultrasound-guided ESP block (20 ml 0.25% bupivacaine) at the end of surgery. PCA regimens (Fentanyl, Tramadol, or Ibuprofen) were 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 flow rates) were monitored for 72 hours.
The study hypothesizes that the Ibuprofen-based PCA will maintain comparable analgesia to opioid-based regimens while improving respiratory performance by avoiding opioid-induced respiratory depression.
Study Design and Blinding:
This was a prospective, randomized, single-center trial. Patients were randomized postoperatively, immediately before PCA initiation (at the postoperative 6th hour, or earlier if analgesia was required), to one of three intervention arms using a computer-generated randomization list (randomizer.org) with 1:1:1 allocation and equal group sizes (n=45 per group). Allocations were concealed in sequentially numbered, opaque, sealed envelopes prepared by an independent person not involved in the study. The study followed a double-blind (participant and outcomes assessor) design. Study drugs were prepared in identical 500 ml saline bags, indistinguishable in color and volume, and the PCA devices were loaded and programmed by a third anesthesiologist not involved in data collection. Patients and the investigators recording visual analog scale (VAS) scores and incentive spirometry flow rates were blinded to group assignments.
Participant flow:
Of 142 eligible patients, 2 declined participation and 5 were excluded before randomization due to intraoperative conversion to thoracotomy; 135 patients were randomized (45 per group).
Note on outcome measure terminology:
Incentive spirometry was performed with a flow-oriented device (Triflo®), which indicates inspiratory flow rate (ml/s). The respiratory outcome measure was originally described as inspiratory volume (ml); this description was corrected to inspiratory flow rate (ml/s) at study completion. The device, measurement procedure and time points were unchanged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group F (Fentanyl Group) | Experimental | Drug: Fentanyl IV PCAPatients 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. |
| Group T (Tramadol Group) | Experimental | Drug: Tramadol IV PCAPatients 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 | Drug: Ibuprofen IV PCAPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - 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.
Key exclusion criteria (12 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl IV PCAPatients 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 | Group F (Fentanyl Group) |
| Tramadol IV PCAPatients 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 | Group T (Tramadol Group) |
| Ibuprofen IV PCAPatients 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 | Drug | Group I (Ibuprofen Group) |
Primary outcome
Postoperative Pain Intensity (VAS)
Time frame: 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.
4 secondary outcomes
Postoperative Maximal Inspiratory Flow Rate (ml/s)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 34739134Feray 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.
- Background: PubMed 39797121Mitchell 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.
- Background: PubMed 25899952Harris 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.
- Background: PubMed 37305403Sun 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.
- Background: PubMed 35941536Yu 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Unal, MD, Prof. principal investigator
University of Health Sciences, Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl IV PCA, Tramadol IV PCA and Ibuprofen IV PCA in people with Postoperative Pain After Thoracic Surgery and Postoperative Pain, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (VAS) (time frame: Postoperative 6, 12, 18, 24, 36, 48, 60, and 72 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07610408, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.