DexmedetomidineNCT04322760
Lidocaine 5% Patch Supplementation to Intra-articular Bupivacaine Dexmedetomidine After Arthroscopic Knee Surgery
A study testing Lidocaine 5% patch with Dexmedetomidine Bupivacaine and Dexmedetomidine Bupivacaine in people with Dexmedetomidine and Lidocaine 5% Patch, run by Tanta University.
Trial summary
Surgery of the knee is a very common procedure which can be very painful and sufficient postoperative pain treatment is often problematic. The aim of this work was to study the effects of supplementation of intra-articular bupivacaine dexmedetomidine with lidocaine 5% patch after arthroscopic knee surgery under… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dexmedetomidine, Lidocaine 5% Patch, Arthroscopic Knee Surgery
- What is being tested?
- Lidocaine 5% patch with Dexmedetomidine Bupivacaine and Dexmedetomidine Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 1 Dec 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients
- ASA I \& II
- Aged between 18 to 60 years
- Weight between 60 to 100 kg
- Scheduled for elective arthroscopic knee surgery
Who cannot join
- patient refusal.
- history of cardiac disease.
- impaired renal or hepatic function.
- hypertension treated with α methyldopa, clonidine, or beta-adrenergic blockers.
- if they have used opioid analgesics within the previous 24 hr.
- previous sensitivity to local anesthetics.
About this study
Official title: Effect of Lidocaine 5% Patch Supplementation to Intra-articular Bupivacaine Dexmedetomidine After Arthroscopic Knee Surgery Under General Anesthesia
Surgery of the knee is a very common procedure which can be very painful and sufficient postoperative pain treatment is often problematic. The aim of this work was to study the effects of supplementation of intra-articular bupivacaine dexmedetomidine with lidocaine 5% patch after arthroscopic knee surgery under general anesthesia and its role in improving quality of anesthesia.
- Being tested
- Lidocaine 5% patch with Dexmedetomidine Bupivacaine, Dexmedetomidine Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 5% patch with Dexmedetomidine BupivacaineDrug
10 ml 0.5 % Bupivacaine and 1µg/kg Dexmedetomidine diluted in 10 ml saline was injected intra-articularly through one of the arthroscopic ports after the end of the surgery under complete aseptic technique and a patch of lidocaine 5% was applied to the skin between the arthroscopic ports
Dexmedetomidine BupivacaineDrug
10 ml 0.5 % Bupivacaine and 1µg/kg Dexmedetomidine diluted in 10 ml saline was injected intra-articularly through one of the arthroscopic ports after the end of the surgery under complete aseptic technique without a patch of lidocaine 5%
| Study group | Role | What they receive |
|---|---|---|
| Group A (control group) | Active comparator | Patients in each received 10 ml 0.5 % bupivacaine and 1µg/kg dexmedetomidine diluted in 10 ml saline injected intra-articularly without lidocaine patch Receives: Drug: Dexmedetomidine Bupivacaine |
| Group B | Experimental | Patients in each received 10 ml 0.5 % bupivacaine and 1µg/kg dexmedetomidine diluted in 10 ml saline injected intra-articularly with a patch of lidocaine 5% was applied to the skin Receives: Drug: Lidocaine 5% patch with Dexmedetomidine Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total dose of postoperative pethidine consumption
The total dose of postoperative pethidine consumption; Pethidine 20 mg was given as rescue analgesia if pain visual analogue visual analogue scale (VAS) ≥4.
Measured: 24 hours
Secondary outcomes (2)
First postoperative analgesia request time
First postoperative analgesia (Pethidine 20 mg) request time
Measured: 24 hours
Pain intensity
Visual analogue scale (VAS) was recorded immediately postoperative and at 30 min, 1, 2, 4, 6, 12 and 24 hours postoperatively. The score ranges from 0 to 10; higher means worse pain
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 posted26 Mar 2020
- Study start1 Dec 2016
- Primary completion30 Nov 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Model description
- Patients were allocated into 2 groups, 20 patients in each received 10 ml 0.5 % bupivacaine and 1µg/kg dexmedetomidine diluted in 10 ml saline injected intra-articularly; group A: no patch, group B: a patch of lidocaine 5% was applied to the skin.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Said Elgebaly,MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322760
- Sponsor's protocol ID
- 31084/07/16
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lidocaine 5% Patch Supplementation to Intra-articular Bupivacaine Dexmedetomidine After Arthroscopic Knee Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04322760
- Acronym / sponsor ID
- 31084/07/16
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 26 Mar 2020 (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.
Surgery of the knee is a very common procedure which can be very painful and sufficient postoperative pain treatment is often problematic. The aim of this work was to study the effects of supplementation of intra-articular bupivacaine dexmedetomidine with lidocaine 5% patch after arthroscopic knee surgery under general anesthesia and its role in improving quality of anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were allocated into 2 groups, 20 patients in each received 10 ml 0.5 % bupivacaine and 1µg/kg dexmedetomidine diluted in 10 ml saline injected intra-articularly; group A: no patch, group B: a patch of lidocaine 5% was applied to the skin.
| Arm | Type | Receives |
|---|---|---|
| Group A (control group) | Active comparator | Drug: Dexmedetomidine BupivacainePatients in each received 10 ml 0.5 % bupivacaine and 1µg/kg dexmedetomidine diluted in 10 ml saline injected intra-articularly without lidocaine patch |
| Group B | Experimental | Drug: Lidocaine 5% patch with Dexmedetomidine BupivacainePatients in each received 10 ml 0.5 % bupivacaine and 1µg/kg dexmedetomidine diluted in 10 ml saline injected intra-articularly with a patch of lidocaine 5% was applied to the skin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult patients
- ASA I \& II
- Aged between 18 to 60 years
- Weight between 60 to 100 kg
- Scheduled for elective arthroscopic knee surgery
Key exclusion criteria (6 listed)
- patient refusal.
- history of cardiac disease.
- impaired renal or hepatic function.
- hypertension treated with α methyldopa, clonidine, or beta-adrenergic blockers.
- if they have used opioid analgesics within the previous 24 hr.
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 |
|---|---|---|
| Lidocaine 5% patch with Dexmedetomidine Bupivacaine10 ml 0.5 % Bupivacaine and 1µg/kg Dexmedetomidine diluted in 10 ml saline was injected intra-articularly through one of the arthroscopic ports after the end of the surgery under complete aseptic technique and a patch of lidocaine 5% was applied to the skin between the arthroscopic ports | Drug | Group B |
| Dexmedetomidine Bupivacaine10 ml 0.5 % Bupivacaine and 1µg/kg Dexmedetomidine diluted in 10 ml saline was injected intra-articularly through one of the arthroscopic ports after the end of the surgery under complete aseptic technique without a patch of lidocaine 5% | Drug | Group A (control group) |
Primary outcome
The total dose of postoperative pethidine consumption
Time frame: 24 hours
The total dose of postoperative pethidine consumption; Pethidine 20 mg was given as rescue analgesia if pain visual analogue visual analogue scale (VAS) ≥4.
2 secondary outcomes
First postoperative analgesia request time
Time frame: 24 hours
Pain intensity
Time frame: 24 hours
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 27 Mar 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 5% patch with Dexmedetomidine Bupivacaine and Dexmedetomidine Bupivacaine in people with Dexmedetomidine and Lidocaine 5% Patch, run by Tanta University.
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 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: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The total dose of postoperative pethidine 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 27 Mar 2020.