Postoperative PainNCT07733128
Analgesia With Transdermal Buprenorphine Patch in Adults Undergoing Video-Assisted Thoracoscopic Surgery
A study testing Buprenorphine (BUP) in people with Postoperative Pain and Thoracic Surgery, run by Clínica Dávila at 1 site in Chile.
Trial summary
Postoperative pain remains a major challenge after video-assisted thoracoscopic surgery (VATS), despite the use of multimodal analgesia. This randomized, triple-blind, placebo-controlled clinical trial will evaluate whether adding a 5 mcg/hour transdermal buprenorphine patch to the standard multimodal analgesic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Thoracic Surgery, Video-Assisted Thoracoscopic Surgery
- What is being tested?
- Buprenorphine (BUP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChile
- Study dates
- 1 Mar 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Scheduled for elective unilateral video-assisted thoracoscopic surgery (VATS).
- American Society of Anesthesiologists (ASA) physical status I-III.
- Able to understand the study procedures and provide written informed consent.
Who cannot join
- Known allergy or hypersensitivity to buprenorphine or any component of the transdermal patch.
- Chronic opioid use before surgery.
- Severe hepatic impairment.
- Pregnancy or breastfeeding.
- Inability to complete postoperative pain assessments.
- Any condition that, in the investigator's opinion, could interfere with study participation or outcome assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Clínica Dávila
Santiago, Santiago Metropolitan, 8431657
Alejandra Sofía Rivera, MsC Epidemiology, 930363776, alejandra.rivera@davila.cl
Bernarda Miranda, Bibliotecary, +56930363776, bmiranda@davila.cl
About this study
Official title: Analgesia With a 5 mcg/Hour Transdermal Buprenorphine Patch as Part of Multimodal Analgesia in Adults Undergoing Unilateral Video-Assisted Thoracoscopic Surgery: A Triple-Blind Randomized Controlled Trial
Postoperative pain remains a major challenge after video-assisted thoracoscopic surgery (VATS), despite the use of multimodal analgesia. This randomized, triple-blind, placebo-controlled clinical trial will evaluate whether adding a 5 mcg/hour transdermal buprenorphine patch to the standard multimodal analgesic regimen reduces postoperative pain in adults undergoing unilateral VATS. Participants will be randomly assigned to receive either transdermal buprenorphine or placebo in addition to standard analgesia. Postoperative pain will be assessed at 24, 48, and 72 hours and 7 days after surgery. Secondary outcomes include opioid rescue requirements, length of hospital stay, postoperative nausea and vomiting, pruritus, and urinary retention.
Read the detailed description
Video-assisted thoracoscopic surgery (VATS) is associated with moderate to severe postoperative pain that may impair respiratory function, delay recovery, prolong hospitalization, and contribute to the development of persistent postoperative pain. Current guidelines recommend multimodal analgesia, including non-opioid analgesics and regional anesthesia techniques, while opioids are generally reserved for rescue analgesia.
Transdermal buprenorphine is a long-acting partial μ-opioid receptor agonist that has demonstrated efficacy in reducing postoperative pain and opioid consumption in several surgical settings. However, evidence regarding its use in thoracic surgery is currently lacking.
This is a single-center, randomized, triple-blind, placebo-controlled clinical trial conducted at Clínica Dávila, Santiago, Chile. Adult patients undergoing unilateral video-assisted thoracoscopic surgery will be randomized in a 1:1 ratio to receive either a 5 mcg/hour transdermal buprenorphine patch plus standard multimodal analgesia or placebo plus standard multimodal analgesia. Randomization will be computer-generated using sequentially numbered opaque sealed envelopes. Participants, investigators, outcome assessors, and the statistician will remain blinded to treatment allocation.
The primary outcome is postoperative pain intensity measured using the Numeric Rating Scale (0-10) at 24, 48, and 72 hours and 7 days after surgery. Secondary outcomes include opioid rescue consumption expressed as morphine equivalents, postoperative nausea and vomiting, pruritus, urinary retention, and length of hospital stay. The planned sample size is 90 participants (45 per group).
- Being tested
- Buprenorphine (BUP), Placebo
- Keywords
- Buprenorphine, Transdermal Patch, Multimodal Analgesia, Video-Assisted Thoracoscopic Surgery, VATS, Postoperative Pain, Randomized Controlled Trial, Thoracic Surgery, Acute Pain, Opioid Analgesia
- 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.
Buprenorphine (BUP)Drug
Transdermal buprenorphine patch (5 mcg/hour) administered preoperatively as part of multimodal analgesia.
PlaceboOther
Placebo transdermal patch identical in appearance to the active patch and administered preoperatively as part of multimodal analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine Patch | Experimental | Participants will receive a 5 mcg/hour transdermal buprenorphine patch before surgery in addition to standard multimodal analgesia. Receives: Drug: Buprenorphine (BUP) |
| Placebo Patch | Placebo comparator | Participants will receive a placebo transdermal patch before surgery in addition to standard multimodal analgesia. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Measured Using the Numeric Rating Scale
Postoperative pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be compared between the buprenorphine and placebo groups across the postoperative assessment time points.
Measured: 24, 48, and 72 hours and 7 days after surgery
Secondary outcomes (5)
Postoperative Rescue Opioid Consumption
Total rescue opioid consumption will be obtained from the clinical record and expressed in milligrams of intravenous morphine equivalents. Opioid consumption will be compared between the study groups.
Measured: From the end of surgery through 7 days after surgery
Incidence of Postoperative Nausea and Vomiting
The presence or absence of postoperative nausea or vomiting will be recorded at each postoperative assessment. The outcome will be reported as the number and percentage of participants experiencing nausea or vomiting in each study group.
Measured: 24, 48, and 72 hours and 7 days after surgery
Incidence of Postoperative Pruritus
The presence or absence of postoperative pruritus will be recorded at each assessment. The outcome will be reported as the number and percentage of participants experiencing pruritus in each study group.
Measured: 24, 48, and 72 hours and 7 days after surgery
Incidence of Postoperative Urinary Retention Requiring Bladder Catheterization
Postoperative urinary retention will be defined as the need for bladder catheterization. The outcome will be reported as the number and percentage of participants requiring catheterization in each study group.
Measured: 24, 48, and 72 hours and 7 days after surgery
Length of Hospital Stay
Length of hospital stay will be calculated as the number of complete days from the postoperative period until hospital discharge, based on the electronic clinical record.
Measured: From the day of surgery until hospital discharge, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either a 5 mcg/hour transdermal buprenorphine patch plus standard multimodal analgesia or placebo plus standard multimodal analgesia.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clínica Dávila
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733128
- Sponsor's protocol ID
- CD2025/035
- Status last verified
- Jan 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study protocol does not include a data-sharing plan. Study data will be anonymized, securely stored, and used exclusively for the purposes described in the approved research protocol, in accordance with applicable ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia With a 5 mcg/Hour Transdermal Buprenorphine Patch as Part of Multimodal Analgesia in Adults Undergoing Unilateral Video-Assisted Thoracoscopic Surgery: A Triple-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07733128
- Acronym / sponsor ID
- CD2025/035
- Keywords
- Buprenorphine, Transdermal Patch, Multimodal Analgesia, Video-Assisted Thoracoscopic Surgery, VATS, Postoperative Pain, Randomized Controlled Trial, Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Clínica DávilaUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 29 Jul 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.
Postoperative pain remains a major challenge after video-assisted thoracoscopic surgery (VATS), despite the use of multimodal analgesia. This randomized, triple-blind, placebo-controlled clinical trial will evaluate whether adding a 5 mcg/hour transdermal buprenorphine patch to the standard multimodal analgesic regimen reduces postoperative pain in adults undergoing unilateral VATS. Participants will be randomly assigned to receive either transdermal buprenorphine or placebo in addition to standard analgesia. Postoperative pain will be assessed at 24, 48, and 72 hours and 7 days after surgery. Secondary outcomes include opioid rescue requirements, length of hospital stay, postoperative nausea and vomiting, pruritus, and urinary retention.
Detailed description
Video-assisted thoracoscopic surgery (VATS) is associated with moderate to severe postoperative pain that may impair respiratory function, delay recovery, prolong hospitalization, and contribute to the development of persistent postoperative pain. Current guidelines recommend multimodal analgesia, including non-opioid analgesics and regional anesthesia techniques, while opioids are generally reserved for rescue analgesia.
Transdermal buprenorphine is a long-acting partial μ-opioid receptor agonist that has demonstrated efficacy in reducing postoperative pain and opioid consumption in several surgical settings. However, evidence regarding its use in thoracic surgery is currently lacking.
This is a single-center, randomized, triple-blind, placebo-controlled clinical trial conducted at Clínica Dávila, Santiago, Chile. Adult patients undergoing unilateral video-assisted thoracoscopic surgery will be randomized in a 1:1 ratio to receive either a 5 mcg/hour transdermal buprenorphine patch plus standard multimodal analgesia or placebo plus standard multimodal analgesia. Randomization will be computer-generated using sequentially numbered opaque sealed envelopes. Participants, investigators, outcome assessors, and the statistician will remain blinded to treatment allocation.
The primary outcome is postoperative pain intensity measured using the Numeric Rating Scale (0-10) at 24, 48, and 72 hours and 7 days after surgery. Secondary outcomes include opioid rescue consumption expressed as morphine equivalents, postoperative nausea and vomiting, pruritus, urinary retention, and length of hospital stay. The planned sample size is 90 participants (45 per group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either a 5 mcg/hour transdermal buprenorphine patch plus standard multimodal analgesia or placebo plus standard multimodal analgesia.
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine Patch | Experimental | Drug: Buprenorphine (BUP)Participants will receive a 5 mcg/hour transdermal buprenorphine patch before surgery in addition to standard multimodal analgesia. |
| Placebo Patch | Placebo comparator | Other: PlaceboParticipants will receive a placebo transdermal patch before surgery in addition to standard multimodal analgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Scheduled for elective unilateral video-assisted thoracoscopic surgery (VATS).
- American Society of Anesthesiologists (ASA) physical status I-III.
- Able to understand the study procedures and provide written informed consent.
Key exclusion criteria (6 listed)
- Known allergy or hypersensitivity to buprenorphine or any component of the transdermal patch.
- Chronic opioid use before surgery.
- Severe hepatic impairment.
- Pregnancy or breastfeeding.
- Inability to complete postoperative pain assessments.
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 |
|---|---|---|
| Buprenorphine (BUP)Transdermal buprenorphine patch (5 mcg/hour) administered preoperatively as part of multimodal analgesia. | Drug | Buprenorphine Patch |
| PlaceboPlacebo transdermal patch identical in appearance to the active patch and administered preoperatively as part of multimodal analgesia. | Other | Placebo Patch |
Primary outcome
Postoperative Pain Intensity Measured Using the Numeric Rating Scale
Time frame: 24, 48, and 72 hours and 7 days after surgery
Postoperative pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be compared between the buprenorphine and placebo groups across the postoperative assessment time points.
5 secondary outcomes
Postoperative Rescue Opioid Consumption
Time frame: From the end of surgery through 7 days after surgery
Incidence of Postoperative Nausea and Vomiting
Time frame: 24, 48, and 72 hours and 7 days after surgery
Incidence of Postoperative Pruritus
Time frame: 24, 48, and 72 hours and 7 days after surgery
Incidence of Postoperative Urinary Retention Requiring Bladder Catheterization
Time frame: 24, 48, and 72 hours and 7 days after surgery
Length of Hospital Stay
Time frame: From the day of surgery until hospital discharge, assessed up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study protocol does not include a data-sharing plan. Study data will be anonymized, securely stored, and used exclusively for the purposes described in the approved research protocol, in accordance with applicable ethical and institutional requirements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buprenorphine (BUP) in people with Postoperative Pain and Thoracic Surgery, run by Clínica Dávila at 1 site in Chile.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Jul 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 Chile. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity Measured Using the Numeric Rating Scale (time frame: 24, 48, and 72 hours and 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2026.