Knee ArthroscopyNCT02730845
Intra-articular Versus Intravenous Dexmedetomidine in Arthroscopic Knee Surgeries Under Local Anesthesia
A study testing Intra-articular dexmedetomidine and Intravenous dexmedetomidine in people with Knee Arthroscopy, run by Mansoura University at 1 site in Egypt.
Trial summary
The present study will be carried to evaluate the efficacy of intra-articular 0.5 bupivacaine with intra-articular or intravenous alpha-2agonist; Dexmedetomidine; for intraoperative anesthesia and postoperative analgesia after arthroscopic knee surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Knee Arthroscopy
- What is being tested?
- Intra-articular dexmedetomidine and Intravenous dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2015to 30 May 2016
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status I or II
- Patients scheduled for elective unilateral knee arthroscopy
Who cannot join
- Refusal of local anesthesia
- History of cardiovascular disease
- History of cerebrovascular disease
- History of respiratory diseases
- History of impaired renal functions
- History of impaired hepatic functions
Show all 16Show fewer
- Pregnancy
- Allergy to the study drugs
- Uncontrolled diabetes
- Coagulopathies
- Hypertension treated with α methyldopa, clonidine or β adrenergic blockers
- Patients receiving chronic pain treatment
- Patients receiving psychoactive drugs
- Patients receiving anticoagulant drugs
- Prior ipsilateral knee surgery
- Infection at site of injection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-articular Versus Intravenous Administration of Dexmedetomidine in Arthroscopic Knee Surgeries: A Prospective Randomized Study
The present study will be carried to evaluate the efficacy of intra-articular 0.5 bupivacaine with intra-articular or intravenous alpha-2agonist; Dexmedetomidine; for intraoperative anesthesia and postoperative analgesia after arthroscopic knee surgery.
Arthroscopic knee surgery is one of the most common minimally invasive orthopedic procedures in recent practice which is frequently performed as a day surgery procedures. It can be done under general, regional or local anesthesia (LA) with or without sedation. It is associated with varying amount of postoperative pain. Postoperative pain negatively influences patient's early ambulation, rehabilitation and psychology which consecutively prolonged the hospital stay.
Read more
Intra-articular administration of local anesthetic for knee arthroscopy is a well-documented procedure that offers many advantages over other anesthesia types. Many anesthesiologists are still trying to improve the technique of local anesthetic administration through using many combinations with LA solutions in order to administer safe anesthesia to those patients and to obtain a pain-free knee with good operating conditions.
Dexmedetomidine is a highly selective α2 adrenergic agonist. It has analgesic, sedative, anxiolytic, hypnotic, sympatholytic, antihypertensive properties with anesthetic sparing effects. It becomes an attractive alternative to the current opioids because it does not have a respiratory depressant or addictive effect.
Read the detailed description
All patients were kept fasting after midnight and received midazolam 5 mg orally as premedication. All patients were premedicated with I.V. midazolam 0.03 mg/kg ten minutes before starting the operation. The anesthetic technique was standardized for all patients. All surgical procedures were performed by the same surgeon and consisted of arthroscopic removal of torn meniscus. Both intra-articular and intravenous solutions were prepared by an individual not involved in the study and the intra-articular drugs were injected by the surgeon (without knowing the contents). The anesthesiologist managing and monitoring the patient throughout the surgery provides IV drugs. No leg holder or tourniquet or surgical drain was used for any of the cases. After preparation and draping the patient's leg, patients were warned prior to each needle stick to decrease anxiety. All procedures were performed under complete aseptic conditions. Skin and subcutaneous tissues at each arthroscopic portal site were anesthetized with LA consisting of injection of a mixture of 2% lidocaine 5 mL with 1:200,000 epinephrine.
Care should be taken to avoid infiltration of the fat pad. It is a relatively aneural structure; as, too much local infiltration allows it to bulge out into the joint during the surgery. Flexion and extension of the knee joint several times help to spread of intra-articular solution and then waiting 20 minutes for anesthesia to take effect is helpful before the surgical incision.
The arthroscope was inserted into the knee, and inflow through the sheath was established. No pump was used for the saline inflow which was maintained through the arthroscope by the gravity. Gravity outflow drained through the superolateral portal. A separate egress cannula was used if indicated. The patient was encouraged to view the video monitor during the procedure. Constant verbal communication between the surgeon and the patient is important throughout the arthroscopic examination and surgery. This keeps the patient anxiety and muscle tension to the minimum which facilitates manipulation of the leg and thorough examination of the entire joint. Once finishing, instruments were removed and portals were closed with a 4-0 absorbable suture subcutaneously and steri-strips. A compression dressing was applied for three days to the knee.
- Conditions
- Knee Arthroscopy
- Being tested
- Intra-articular dexmedetomidine, Intravenous dexmedetomidine
- Keywords
- Elective, local anesthesia, knee arthroscopy, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular dexmedetomidineDrug
Patients will receive an intra-articular mixture of 19 ml bupivacaine 0.5% with epinephrine 1:200.000 added to 1ml (1 µg/kg) of dexmedetomidine (total volume 20 ml), and i.v. saline 20 ml infused over 10 min starting with local anesthesia
Intravenous dexmedetomidineDrug
Patients will be injected intra-articularly with mixture of 19 ml 0.5% bupivacaine with epinephrine 1:200.000 and 1 ml of isotonic saline (total volume 20 ml), in addition to i.v. 20 ml saline containing 1 µg/kg dexmedetomidine over 10 min infusion starting with local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular dexmedetomidine | Active comparator | Patients will be subjected for elective knee arthroscopy under local anesthesia (Intra-articular dexmedetomidine + Intra-articular bupivacaine). Receives: Drug: Intra-articular dexmedetomidine |
| Intravenous dexmedetomidine | Placebo comparator | patients will be subjected for elective knee arthroscopy under local anesthesia (i.v. dexmedetomidine + Intra-articular bupivacaine). Receives: Drug: Intravenous dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Pain will be assessed using 10 cm visual analogue scale (VAS)
Measured: for 24 hours starting immediately before performing the procedure
Secondary outcomes (10)
Heart rate
Measured: starting immediately before performing the procedure
Blood pressure
Changes in systolic and mean blood pressure
Measured: starting immediately before performing the procedure
Oxygen saturation
Changes in peripheral oxygen saturation
Measured: starting immediately before performing the procedure
Respiratory rate
Changes in respiratory rates will be recorded
Measured: starting immediately before performing the procedure
Level of sedation
will be evaluated using the following scale: (5= awake/alert to 0= asleep/unarousable )
Measured: For 24 hours after performing the injection
Patient Satisfaction Score
will be assessed using the following scale: 5= very satisfied, 4= satisfied, 3 = neutral, 2 = dissatisfied,
1 = very dissatisfied
Measured: For 24 hours after performing the procedure
Time to first postoperative analgesic requirement
This will be recorded as the time to first postoperative analgesic requirement
Measured: For 24 hours after performing the injection
Intraoperative and postoperative side effects
These include nausea, vomiting, hypotension, bradycardia, respiratory depression, Hypertension
Measured: For 24 hours after performing the injection
Time to mobilization out of bed
will be recorded in minutes from skin closure
Measured: For 48 hours after performing the procedure
Post-anesthesia care unit (PACU) length of stay
will be recorded from time between transfer from the operating room to PACU and discharge
Measured: For 4 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study start1 Dec 2015
- Primary completion1 Apr 2016
- Study completion30 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroscopyStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarek H Ramadan, MD, Principal investigator, Lecturer of Anesthesia and Surgical Intensive CareReem A AbdelRaouf, MD, Study director, Lecturer of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730845
- Sponsor's protocol ID
- R∕ 15.10.40
- Status last verified
- Sep 2020
- First submitted
- 11 Feb 2016
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Versus Intravenous Administration of Dexmedetomidine in Arthroscopic Knee Surgeries: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02730845
- Acronym / sponsor ID
- R∕ 15.10.40
- Conditions
- Knee Arthroscopy
- Keywords
- Elective, local anesthesia, knee arthroscopy, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 30 May 2016 (actual)
- First posted
- 7 Apr 2016 (estimated)
- 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 present study will be carried to evaluate the efficacy of intra-articular 0.5 bupivacaine with intra-articular or intravenous alpha-2agonist; Dexmedetomidine; for intraoperative anesthesia and postoperative analgesia after arthroscopic knee surgery.
Arthroscopic knee surgery is one of the most common minimally invasive orthopedic procedures in recent practice which is frequently performed as a day surgery procedures. It can be done under general, regional or local anesthesia (LA) with or without sedation. It is associated with varying amount of postoperative pain. Postoperative pain negatively influences patient's early ambulation, rehabilitation and psychology which consecutively prolonged the hospital stay.
Intra-articular administration of local anesthetic for knee arthroscopy is a well-documented procedure that offers many advantages over other anesthesia types. Many anesthesiologists are still trying to improve the technique of local anesthetic administration through using many combinations with LA solutions in order to administer safe anesthesia to those patients and to obtain a pain-free knee with good operating conditions.
Dexmedetomidine is a highly selective α2 adrenergic agonist. It has analgesic, sedative, anxiolytic, hypnotic, sympatholytic, antihypertensive properties with anesthetic sparing effects. It becomes an attractive alternative to the current opioids because it does not have a respiratory depressant or addictive effect.
Detailed description
All patients were kept fasting after midnight and received midazolam 5 mg orally as premedication. All patients were premedicated with I.V. midazolam 0.03 mg/kg ten minutes before starting the operation. The anesthetic technique was standardized for all patients. All surgical procedures were performed by the same surgeon and consisted of arthroscopic removal of torn meniscus. Both intra-articular and intravenous solutions were prepared by an individual not involved in the study and the intra-articular drugs were injected by the surgeon (without knowing the contents). The anesthesiologist managing and monitoring the patient throughout the surgery provides IV drugs. No leg holder or tourniquet or surgical drain was used for any of the cases. After preparation and draping the patient's leg, patients were warned prior to each needle stick to decrease anxiety. All procedures were performed under complete aseptic conditions. Skin and subcutaneous tissues at each arthroscopic portal site were anesthetized with LA consisting of injection of a mixture of 2% lidocaine 5 mL with 1:200,000 epinephrine.
Care should be taken to avoid infiltration of the fat pad. It is a relatively aneural structure; as, too much local infiltration allows it to bulge out into the joint during the surgery. Flexion and extension of the knee joint several times help to spread of intra-articular solution and then waiting 20 minutes for anesthesia to take effect is helpful before the surgical incision.
The arthroscope was inserted into the knee, and inflow through the sheath was established. No pump was used for the saline inflow which was maintained through the arthroscope by the gravity. Gravity outflow drained through the superolateral portal. A separate egress cannula was used if indicated. The patient was encouraged to view the video monitor during the procedure. Constant verbal communication between the surgeon and the patient is important throughout the arthroscopic examination and surgery. This keeps the patient anxiety and muscle tension to the minimum which facilitates manipulation of the leg and thorough examination of the entire joint. Once finishing, instruments were removed and portals were closed with a 4-0 absorbable suture subcutaneously and steri-strips. A compression dressing was applied for three days to the knee.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular dexmedetomidine | Active comparator | Drug: Intra-articular dexmedetomidinePatients will be subjected for elective knee arthroscopy under local anesthesia (Intra-articular dexmedetomidine + Intra-articular bupivacaine). |
| Intravenous dexmedetomidine | Placebo comparator | Drug: Intravenous dexmedetomidinepatients will be subjected for elective knee arthroscopy under local anesthesia (i.v. dexmedetomidine + Intra-articular bupivacaine). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I or II
- Patients scheduled for elective unilateral knee arthroscopy
Key exclusion criteria (16 listed)
- Refusal of local anesthesia
- History of cardiovascular disease
- History of cerebrovascular disease
- History of respiratory diseases
- History of impaired renal functions
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 |
|---|---|---|
| Intra-articular dexmedetomidinePatients will receive an intra-articular mixture of 19 ml bupivacaine 0.5% with epinephrine 1:200.000 added to 1ml (1 µg/kg) of dexmedetomidine (total volume 20 ml), and i.v. saline 20 ml infused over 10 min starting with local anesthesia | Drug | Intra-articular dexmedetomidine |
| Intravenous dexmedetomidinePatients will be injected intra-articularly with mixture of 19 ml 0.5% bupivacaine with epinephrine 1:200.000 and 1 ml of isotonic saline (total volume 20 ml), in addition to i.v. 20 ml saline containing 1 µg/kg dexmedetomidine over 10 min infusion starting with local anesthesia. | Drug | Intravenous dexmedetomidine |
Primary outcome
Pain scores
Time frame: for 24 hours starting immediately before performing the procedure
Pain will be assessed using 10 cm visual analogue scale (VAS)
10 secondary outcomes
Heart rate
Time frame: starting immediately before performing the procedure
Blood pressure
Time frame: starting immediately before performing the procedure
Oxygen saturation
Time frame: starting immediately before performing the procedure
Respiratory rate
Time frame: starting immediately before performing the procedure
Level of sedation
Time frame: For 24 hours after performing the injection
Patient Satisfaction Score
Time frame: For 24 hours after performing the procedure
Time to first postoperative analgesic requirement
Time frame: For 24 hours after performing the injection
Intraoperative and postoperative side effects
Time frame: For 24 hours after performing the injection
Time to mobilization out of bed
Time frame: For 48 hours after performing the procedure
Post-anesthesia care unit (PACU) length of stay
Time frame: For 4 hours after surgery
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 22 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Tarek H Ramadan, MD principal investigator
Lecturer of Anesthesia and Surgical Intensive Care
Reem A AbdelRaouf, MD study director
Lecturer of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular dexmedetomidine and Intravenous dexmedetomidine in people with Knee Arthroscopy, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 16 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 22 Sep 2020. 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 Egypt. 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?
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?
Pain scores (time frame: for 24 hours starting immediately before performing the procedure). 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 22 Sep 2020.