Patients Aged Between 18 and 65years Undergoing Total Knee ArthroplastyPhase 4NCT05042648
Role of Preoperative Transdermal Buprenorphine Patch in Reducing Postoperative Opioids Consumption in Patients Undergoing Total Knee Arthroplasties - A Randomised Controlled Trial.
A Phase 4 study testing Buprenorphine patch in people with Patients Aged Between 18 and 65years Undergoing Total Knee Arthroplasty, run by Security Forces Hospital at 1 site in Saudi Arabia.
Trial summary
This study will help us in understanding the role of transdermal buprenorphine patch in reducing consumption of opioids in patients undergoing total knee replacement. The objective of our study is to investigate the role of preoperative TDB patch in reducing postoperative opioids consumption in patients undergoing… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patients Aged Between 18 and 65years Undergoing Total Knee Arthroplasty
- What is being tested?
- Buprenorphine patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2021to 15 Dec 2023
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65years, scheduled to undergo total knee arthroplasty with an ASA score of 1 to 3 will be included in the study.
Who cannot join
- Patients who will refuse enrollment or later request removal from the study, those who are unable to give informed consent and patients with contraindications for regional anesthesia like known allergy to local anesthetics, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate patient controlled analgesia (PCA) system, psychiatric disorders or use of psychiatric medications and known allergy to TDB patch.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Security Forces Hospital Program
Riyadh
Anwar ul Huda, FRCA, 00966502654719, hudaanwar90@yahoo.com
About this study
This study will help us in understanding the role of transdermal buprenorphine patch in reducing consumption of opioids in patients undergoing total knee replacement. The objective of our study is to investigate the role of preoperative TDB patch in reducing postoperative opioids consumption in patients undergoing total knee arthroplasties. Patients aged between 18 and 65years, scheduled to undergo total knee arthroplasty with an ASA score of 1 to 3 will be included in the study.
Read the detailed description
Effective postoperative pain control is a major challenge to the treating surgeons and Anaesthetists. Most opioids cause side effects such as sedation, nausea, vomiting, and respiratory depression. A number of other modalities have also been recommended for treatment of post-operative pain, including epidural infusion, patient-controlled analgesia, peripheral nerve block, continuous intra-articular infusion and local intra-articular analgesic injection. However, all of these treatments are invasive and aggressive and are potentially associated with regional bleeding, infection and nerve damage.
In the study by Londhe et al, all patients received peri-articular local anesthetic infiltration and then epidural/femoral nerve block infusion for 72 hours postoperatively. Group A received the TDB patch 5 mcg applied at the end of surgery. Group B received a combination of paracetamol and tramadol. They concluded that TDB patch is more efficacious in reducing postoperative pain after TKA surgery and can be safely used with fewer systemic side effects when compared to conventional analgesics.
The objective of our study is to investigate the role of preoperative TDB patch in reducing postoperative opioids consumption in patients undergoing total knee arthroplasties.
- Being tested
- Buprenorphine patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine patchDrug
Group B will receive buprenorphine patch of 10 mg (sustained release of 10 µg/h) applied either on chest or on outer side of arm 12 h before surgery. The transdermal buprenorphine patch should be applied to intact skin on the flat surfaces of the upper outer arm, upper chest, upper back, or the side of the chest. The skin should be dry, clean, non irritated, non hairy (hair should be trimmed with scissors, not shaved), and without large scars.
| Study group | Role | What they receive |
|---|---|---|
| Control group (Group A) | No intervention | Group A will receive no intervention |
| Buprenorphine group (Group B) | Experimental | Group B will receive buprenorphine patch of 10 mg (sustained release of 10 µg/h) applied either on chest or on outer side of arm 12 h before surgery. The transdermal buprenorphine patch should be applied to intact skin on the flat surfaces of the upper outer arm, upper chest, upper back, or the side of the chest. Receives: Drug: Buprenorphine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine (PCA) consumption
24 hours morphine consumption
Measured: 24 hours
Secondary outcomes (2)
Pain score measured by Numeric rating scale (NRS)
NRS pain score at 15th minute, 30th minute and 1st, 2nd, 6th, 12th, 18th and 24th hours both at rest and on movement
Measured: 15th minute, 30th minute and 1st, 2nd, 6th, 12th, 18th and 24th hours
Rescue analgesic use
rescue analgesic use within the first 24h.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Dec 2021
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Aged Between 18 and 65years Undergoing Total Knee ArthroplastyStudies 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Security Forces Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anwar ul Huda, Security Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042648
- Sponsor's protocol ID
- SecurityFH
- Status last verified
- Apr 2023
- First submitted
- 4 Sep 2021
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be shared on request
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Preoperative Transdermal Buprenorphine Patch in Reducing Postoperative Opioids Consumption in Patients Undergoing Total Knee Arthroplasties - A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05042648
- Acronym / sponsor ID
- SecurityFH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Security Forces HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 13 Sep 2021 (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 will help us in understanding the role of transdermal buprenorphine patch in reducing consumption of opioids in patients undergoing total knee replacement. The objective of our study is to investigate the role of preoperative TDB patch in reducing postoperative opioids consumption in patients undergoing total knee arthroplasties. Patients aged between 18 and 65years, scheduled to undergo total knee arthroplasty with an ASA score of 1 to 3 will be included in the study.
Detailed description
Effective postoperative pain control is a major challenge to the treating surgeons and Anaesthetists. Most opioids cause side effects such as sedation, nausea, vomiting, and respiratory depression. A number of other modalities have also been recommended for treatment of post-operative pain, including epidural infusion, patient-controlled analgesia, peripheral nerve block, continuous intra-articular infusion and local intra-articular analgesic injection. However, all of these treatments are invasive and aggressive and are potentially associated with regional bleeding, infection and nerve damage.
In the study by Londhe et al, all patients received peri-articular local anesthetic infiltration and then epidural/femoral nerve block infusion for 72 hours postoperatively. Group A received the TDB patch 5 mcg applied at the end of surgery. Group B received a combination of paracetamol and tramadol. They concluded that TDB patch is more efficacious in reducing postoperative pain after TKA surgery and can be safely used with fewer systemic side effects when compared to conventional analgesics.
The objective of our study is to investigate the role of preoperative TDB patch in reducing postoperative opioids consumption in patients undergoing total knee arthroplasties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (Group A) | No intervention | –Group A will receive no intervention |
| Buprenorphine group (Group B) | Experimental | Drug: Buprenorphine patchGroup B will receive buprenorphine patch of 10 mg (sustained release of 10 µg/h) applied either on chest or on outer side of arm 12 h before surgery. The transdermal buprenorphine patch should be applied to intact skin on the flat surfaces of the upper outer arm, upper chest, upper back, or the side of the chest. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged between 18 and 65years, scheduled to undergo total knee arthroplasty with an ASA score of 1 to 3 will be included in the study.
Key exclusion criteria (1 listed)
- Patients who will refuse enrollment or later request removal from the study, those who are unable to give informed consent and patients with contraindications for regional anesthesia like known allergy to local anesthetics, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate patient controlled analgesia (PCA) system, psychiatric disorders or use of psychiatric medications and known allergy to TDB patch.
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 patchGroup B will receive buprenorphine patch of 10 mg (sustained release of 10 µg/h) applied either on chest or on outer side of arm 12 h before surgery. The transdermal buprenorphine patch should be applied to intact skin on the flat surfaces of the upper outer arm, upper chest, upper back, or the side of the chest. The skin should be dry, clean, non irritated, non hairy (hair should be trimmed with scissors, not shaved), and without large scars. | Drug | Buprenorphine group (Group B) |
Primary outcome
morphine (PCA) consumption
Time frame: 24 hours
24 hours morphine consumption
2 secondary outcomes
Pain score measured by Numeric rating scale (NRS)
Time frame: 15th minute, 30th minute and 1st, 2nd, 6th, 12th, 18th and 24th hours
Rescue analgesic use
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: Yes. It will be shared on request
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.
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 patch in people with Patients Aged Between 18 and 65years Undergoing Total Knee Arthroplasty, run by Security Forces Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anwar ul Huda, FRCA (00966118024331, hudaanwar90@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morphine (PCA) consumption (time frame: 24 hours). 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 4 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.