Postoperative PainPhase 4NCT06742554
Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthroscopy
A Phase 4 study testing Buprenorphine transdermal patch and Tramadol in people with Postoperative Pain and Shoulder Pain, run by medina medical center at 1 site in Saudi Arabia.
Trial summary
This study compares the efficacy, safety, and patient satisfaction of the Buprenorphine 10 mg transdermal patch versus Tramadol for postoperative analgesia in shoulder arthroscopic surgery. The study hypothesizes that Buprenorphine provides superior pain relief with fewer side effects compared to Tramadol. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Shoulder Pain, Opioid Analgesia
- What is being tested?
- Buprenorphine transdermal patch and Tramadol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2024to 30 Apr 2025
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years.
- Patients undergoing elective shoulder arthroscopy.
- Classified as ASA (American Society of Anesthesiologists) physical status I or II.
- Able to provide informed consent.
- Willing to comply with study protocols and follow-up assessments
Who cannot join
- Known allergy or hypersensitivity to Buprenorphine, Tramadol, or any related compounds.
- History of substance abuse, opioid dependency, or chronic pain requiring ongoing analgesic therapy.
- Pregnant or breastfeeding individuals.
- Presence of severe hepatic, renal, or respiratory disease.
- Any psychiatric or neurological condition that might interfere with pain perception or reporting (e.g., dementia, severe anxiety).
- Participation in another clinical trial within the last 30 days.
- Inability to apply or tolerate a transdermal patch (e.g., due to skin disorders or sensitivities).
- Contraindications to interscalene brachial plexus block, such as infection at the site, coagulopathy, or pre-existing neuropathy in the upper limb.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthroscopy: a Randomized Controlled Trial.
This study compares the efficacy, safety, and patient satisfaction of the Buprenorphine 10 mg transdermal patch versus Tramadol for postoperative analgesia in shoulder arthroscopic surgery. The study hypothesizes that Buprenorphine provides superior pain relief with fewer side effects compared to Tramadol.
- Conditions
- Postoperative Pain, Shoulder Pain, Opioid Analgesia, Tramadol, Buprenorphine, Arthroscopy
- Being tested
- Buprenorphine transdermal patch, Tramadol
- Keywords
- buprinorphin, transdermal, tramadol
- Medical subject headings
- Pain, Postoperative, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine transdermal patchDrug
Buprenorphine Transdermal Patch (10 mg): Applied once before surgery for continuous pain control.
Interscalene Brachial Plexus Block: Administered intraoperatively using 25 mL of 0.5% bupivacaine.
TramadolDrug
Tramadol: Administered orally or intravenously at a standard dose of 100 mg every 8 hours, based on patient-reported pain levels.
Interscalene Brachial Plexus Block: Administered intraoperatively using 25 mL of 0.5% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine Transdermal Patch | Active comparator | Participants in this arm will receive a 10 mg Buprenorphine transdermal patch, applied 4 hours before shoulder arthroscopic surgery. The patch delivers a steady dose of Buprenorphine for up to 7 days, providing sustained postoperative analgesia. All participants will also undergo an interscalene brachial plexus block (ISBPB) as part of their anesthesia protocol.
Interscalene Brachial Plexus Block: Administered intraoperatively using 25 mL of 0.5% bupivacaine. Receives: Drug: Buprenorphine transdermal patch |
| Tramadol | Active comparator | Participants in this arm will receive Tramadol for postoperative pain management. The medication will be administered at a dose of 100 mg every 8 hours as needed, beginning after the interscalene brachial plexus block (ISBPB) wears off.
Interscalene Brachial Plexus Block: Administered intraoperatively using 25 mL of 0.5% bupivacaine. Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Postoperative pain scores measured using the The Numeric Rating Scale over 72 hours. It involves asking participants to rate their pain on a scale of 0 to 10, where:
- 0 represents "No Pain"
- 10 represents "Worst Possible Pain" Lower scores indicate better outcomes.
Measured: Pain intensity will be measured using the The numeric rating scale , recorded at 6, 12, 24, 48, and 72 hours after surgery.
Duration of Effective Analgesia
The time from the full recovery from the interscalene brachial plexus block (ISBPB) until 72 hrs postoperatively.
Measured: From the time of surgery (Day 0) to 72 hours postoperatively.
Secondary outcomes (4)
Incidence of Adverse Effects
he number of participants experiencing adverse effects (e.g., nausea, vomiting, dizziness, sedation, or skin irritation) will be recorded. Data will be collected through direct patient reports and clinical observations.
Measured: From the time of surgery (Day 0) to 72 hours postoperatively
Patient Satisfaction (Likert Scale)
Patient satisfaction with pain management will be assessed using a 5-point Likert scale, where 1 indicates "very dissatisfied" and 5 indicates "very satisfied." Higher scores reflect better patient satisfaction
Measured: At 72 hours postoperatively
Early Mobilization and Rehabilitation Adherence
The ability to perform early mobilization and adhere to physiotherapy protocols (e.g., range-of-motion exercises) will be assessed by physical therapists. This will be rated as "Full adherence," "Partial adherence," or "No adherence." Full adherence indicates a better outcome.
Measured: From 24 to 72 hours postoperatively.
Total Rescue Analgesic Consumption
The total amount of rescue analgesics (e.g., acetaminophen or additional opioids) required by each participant will be recorded in milligrams. Lower consumption indicates better efficacy of the primary analgesic.
Measured: From the time of surgery (Day 0) 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 posted19 Dec 2024
- Study start1 Dec 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, parallel-assignment study where participants are allocated to one of two intervention groups. Group A will receive a Buprenorphine 10 mg transdermal patch applied 4 hours prior to surgery, providing sustained analgesia for up to 72 hours postoperatively. Group B will receive Tramadol at a standard dosage (100 mg every 8 hours as needed for pain) starting postoperatively. Both groups will receive interscalene brachial plexus block (ISBPB) as part of their intraoperative anesthesia.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- medina medical center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Salah Elsawy, medina medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742554
- Sponsor's protocol ID
- BUT002/2024
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including primary and secondary outcome measures, will be shared.
Publications
Arshad Z, Prakash R, Gautam S, Kumar S. Comparison between Transdermal Buprenorphine and Transdermal Fentanyl for Postoperative Pain Relief after Major Abdominal Surgeries. J Clin Diagn Res. 2015 Dec;9(12):UC01-4. doi: 10.7860/JCDR/2015/16327.6917. Epub 2015 Dec 1.
PubMed 26816973
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthroscopy: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06742554
- Acronym / sponsor ID
- BUT002/2024
- Conditions
- Postoperative Pain, Shoulder Pain, Opioid Analgesia, Tramadol, Buprenorphine, Arthroscopy
- Keywords
- buprinorphin, transdermal, tramadol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- medina medical centerUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 19 Dec 2024 (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.
This study compares the efficacy, safety, and patient satisfaction of the Buprenorphine 10 mg transdermal patch versus Tramadol for postoperative analgesia in shoulder arthroscopic surgery. The study hypothesizes that Buprenorphine provides superior pain relief with fewer side effects compared to Tramadol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, parallel-assignment study where participants are allocated to one of two intervention groups. Group A will receive a Buprenorphine 10 mg transdermal patch applied 4 hours prior to surgery, providing sustained analgesia for up to 72 hours postoperatively. Group B will receive Tramadol at a standard dosage (100 mg every 8 hours as needed for pain) starting postoperatively. Both groups will receive interscalene brachial plexus block (ISBPB) as part of their intraoperative anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine Transdermal Patch | Active comparator | Drug: Buprenorphine transdermal patchParticipants in this arm will receive a 10 mg Buprenorphine transdermal patch, applied 4 hours before shoulder arthroscopic surgery. The patch delivers a steady dose of Buprenorphine for up to 7 days, providing sustained postoperative analgesia. All participants will also undergo an interscalene brachial plexus block (ISBPB) as part of their anesthesia protocol. Interscalene Brachial Plexus Block: Administered intraoperatively using 25 mL of 0.5% bupivacaine. |
| Tramadol | Active comparator | Drug: TramadolParticipants in this arm will receive Tramadol for postoperative pain management. The medication will be administered at a dose of 100 mg every 8 hours as needed, beginning after the interscalene brachial plexus block (ISBPB) wears off. Interscalene Brachial Plexus Block: Administered intraoperatively using 25 mL of 0.5% bupivacaine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 65 years.
- Patients undergoing elective shoulder arthroscopy.
- Classified as ASA (American Society of Anesthesiologists) physical status I or II.
- Able to provide informed consent.
- Willing to comply with study protocols and follow-up assessments
Key exclusion criteria (8 listed)
- Known allergy or hypersensitivity to Buprenorphine, Tramadol, or any related compounds.
- History of substance abuse, opioid dependency, or chronic pain requiring ongoing analgesic therapy.
- Pregnant or breastfeeding individuals.
- Presence of severe hepatic, renal, or respiratory disease.
- Any psychiatric or neurological condition that might interfere with pain perception or reporting (e.g., dementia, severe anxiety).
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 transdermal patchBuprenorphine Transdermal Patch (10 mg): Applied once before surgery for continuous pain control. Interscalene Brachial Plexus Block: Administered intraoperatively using 25 mL of 0.5% bupivacaine. | Drug | Buprenorphine Transdermal Patch |
| TramadolTramadol: Administered orally or intravenously at a standard dose of 100 mg every 8 hours, based on patient-reported pain levels. Interscalene Brachial Plexus Block: Administered intraoperatively using 25 mL of 0.5% bupivacaine. | Drug | Tramadol |
Primary outcome
Postoperative pain score
Time frame: Pain intensity will be measured using the The numeric rating scale , recorded at 6, 12, 24, 48, and 72 hours after surgery.
Postoperative pain scores measured using the The Numeric Rating Scale over 72 hours. It involves asking participants to rate their pain on a scale of 0 to 10, where: * 0 represents "No Pain" * 10 represents "Worst Possible Pain" Lower scores indicate better outcomes.
Duration of Effective Analgesia
Time frame: From the time of surgery (Day 0) to 72 hours postoperatively.
The time from the full recovery from the interscalene brachial plexus block (ISBPB) until 72 hrs postoperatively.
4 secondary outcomes
Incidence of Adverse Effects
Time frame: From the time of surgery (Day 0) to 72 hours postoperatively
Patient Satisfaction (Likert Scale)
Time frame: At 72 hours postoperatively
Early Mobilization and Rehabilitation Adherence
Time frame: From 24 to 72 hours postoperatively.
Total Rescue Analgesic Consumption
Time frame: From the time of surgery (Day 0) to 72 hours postoperatively
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 20 Dec 2024.
- Background: PubMed 26816973Arshad Z, Prakash R, Gautam S, Kumar S. Comparison between Transdermal Buprenorphine and Transdermal Fentanyl for Postoperative Pain Relief after Major Abdominal Surgeries. J Clin Diagn Res. 2015 Dec;9(12):UC01-4. doi: 10.7860/JCDR/2015/16327.6917. Epub 2015 Dec 1.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including primary and secondary outcome measures, will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine transdermal patch and Tramadol in people with Postoperative Pain and Shoulder Pain, run by medina medical center at 1 site in Saudi Arabia.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 20 Dec 2024. 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 Saudi Arabia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 score (time frame: Pain intensity will be measured using the The numeric rating scale , recorded at 6, 12, 24, 48, and 72 hours after surgery.). The study lists 2 primary outcomes in all. 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 NCT06742554, which also lists 1 linked publication.
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 20 Dec 2024.