Arthroscopic Medial MeniscectomyPhase 4NCT03030950
Perineural Dexmedetomidine in Adductor Canal Block
A Phase 4 study testing Dexmedetomidine and Normal saline in people with Arthroscopic Medial Meniscectomy, run by Cairo University at 1 site in Egypt.
Trial summary
This study is designed to explore the effects of peri-neural dexmedetomidine on the duration and motor sparing potentials of adductor canal block in adult patients undergoing arthroscopic medical meniscectomy in the setting of multimodal analgesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Arthroscopic Medial Meniscectomy
- What is being tested?
- Dexmedetomidine and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2018to 5 Dec 2018
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients of aged (18-45), ASA physical status I or II undergoing arthroscopic medial meniscectomy.
Who cannot join
- Body mass index greater than 35 kg/m2.
- Pregnancy.
- Unstable coronary artery disease, congestive heart failure, or arrhythmias.
- Baseline heart rate (HR) less than 60 beats/min or baseline systolic blood pressure less than 100 mmHg.
- Pre-existing neurological deficits or neuropathy.
- Significant psychiatric or cognitive conditions interfering with consent or assessment.
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- Significant renal or hepatic impairment;
- Severe bronchopulmonary disease, including chronic obstructive pulmonary disease and obstructive sleep apnea.
- Known contraindications to peripheral nerve block, including local skin infections, bleeding diathesis, and coagulopathy.
- Allergies to local anesthetics, dexmedetomidine, or any component of multimodal analgesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Peri-neural Dexmedetomidine on the Pharmacodynamic Profile of Bupivacaine-induced Adductor Canal Block in Patients Undergoing Arthroscopic Medial Meniscectomy
This study is designed to explore the effects of peri-neural dexmedetomidine on the duration and motor sparing potentials of adductor canal block in adult patients undergoing arthroscopic medical meniscectomy in the setting of multimodal analgesia. The investigators ultimate goal is to increase the postoperative analgesic time and to preserve quadriceps muscle strength to promote safe and early ambulation.
Read the detailed description
Peripheral nerve blocks using long-acting local anesthetics are commonly utilized as the sole anesthetic technique or as an adjuvant to general anesthesia for post-operative pain management. However, the duration of sensory block after single dose of long acting local anesthetics is not consistently sufficient to avoid the use of postoperative opioids. Many adjuvants were added to local anesthetics to augment the potency and prolong the duration of peripheral nerve blocks. Alpha-2 adrenoceptor agonists such as clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine. Peri-neural dexmedetomidine was evaluated in animal studies where it prolonged the duration of sensory and motor blocks of local anesthetics without any evidence of neurotoxicity for up to 14 days after initial administration. The effectiveness of perineural dexmedetomidine in augmenting the duration of sensory block of upper limb extremity blocks is based on good quality clinical evidence.
Arthroscopic knee surgery is associated with severe postoperative pain which could be adequately managed by femoral nerve block. However femoral nerve block has been associated with significant motor block and decreased quadriceps muscle strength which may delay ambulation and increase the risk of falling. More recently, adductor canal block (ACB) emerged as a selective motor sparing effective variant of femoral nerve block. Compared with baseline values, the adductor canal block reduces quadriceps muscle strength by 8%, versus 49% for the femoral nerve block. A recent dose finding MRI study reported that 20 ml of local anesthetic is the closest volume to the ED95 for adductor canal block with minimal proximal spread and an estimated success probability of 95.1% (95% credibility interval: 91-98%).
- Conditions
- Arthroscopic Medial Meniscectomy
- Being tested
- Dexmedetomidine, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
to investigate the effect of dexmedetomidine on motor and sensory properties of adductor canal block
Normal salineDrug
Also called Saline
to give normal saline to the other group as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Adductor canal block will be performed before induction of general anesthesia. Patients will be positioned in the supine position with knee slightly flexed and leg externally rotated followed by ultrasound scanning of the middle of thigh using 13-6 MHz linear array probe. The ultrasound probe will be placed over the anterior aspect of the patient's thigh, mid-point between the inguinal crease and medial femoral condyle. The scan will be focused on the femoral artery pulsations aiming to try to visualize the nerves in the adductor canal on both sides (lateral and medial) of the pulsating femoral artery. 20 ml bupivacaine 0.25% combined with 75 mcg dexmedetomidine will be injected. The study solution will be injected underneath the fascia of sartorius muscle. Receives: Drug: Dexmedetomidine |
| Control group | Placebo comparator | Adductor canal block will be performed before induction of general anesthesia. Patients will be positioned in the supine position with knee slightly flexed and leg externally rotated followed by ultrasound scanning of the middle of thigh using 13-6 MHz linear array probe. The ultrasound probe will be placed over the anterior aspect of the patient's thigh, mid-point between the inguinal crease and medial femoral condyle. The scan will be focused on the femoral artery pulsations aiming to try to visualize the nerves in the adductor canal on both sides (lateral and medial) of the pulsating femoral artery. 20 ml bupivacaine 0.25% combined with 75 mcg dexmedetomidine will be injected. The study solution will be injected underneath the fascia of sartorius muscle. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
the time passed till the patient first analgesic request
Measured: 24 hours
Secondary outcomes (8)
richmond agitation sedation scale
A scale to assess the patient sedation and agitation
Measured: 24 hours
duration of sensory block
The time needed to regain the patient sensation
Measured: 24 hours
onset of sensory block
A blinded investigator will assess sensory block with pinprick test every 5 min for 30 min after injection of the study medication using a 3-point scale: 0 ═ complete loss of sensation, 1 ═ partial loss of sensation and 2 ═ normal sensation. Assessment will be done in comparison to contra-lateral area
Measured: minutes
blood pressure
mmHg
Measured: 24 hours
heart rate
beat per minutes
Measured: 24 hours
onset of motor block (by assessment of quadriceps muscle strength)
The maximum voluntary isometric contraction (MVIC) of the quadriceps femoris muscle will be measured using a handheld dynamometer
Measured: minutes
resting visual analogue score
the grade of pain during rest as experienced by the patient, rated from 0 to 10
Measured: 24 hours
dynamic visual analogue score
the grade of pain with movement as experienced by the patient, rated from 0 to 10
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 posted25 Jan 2017 (estimated)
- Study start25 Jan 2018
- Primary completion1 Dec 2018
- Study completion5 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Medial MeniscectomyStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Mohamed Abdulatif, Professor, Study director, Professor and member of research committee of anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030950
- Sponsor's protocol ID
- N-31-2016
- Status last verified
- Jan 2019
- First submitted
- 19 Jan 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peri-neural Dexmedetomidine on the Pharmacodynamic Profile of Bupivacaine-induced Adductor Canal Block in Patients Undergoing Arthroscopic Medial Meniscectomy
- ClinicalTrials.gov ID
- NCT03030950
- Acronym / sponsor ID
- N-31-2016
- Conditions
- Arthroscopic Medial Meniscectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 25 Jan 2017 (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.
This study is designed to explore the effects of peri-neural dexmedetomidine on the duration and motor sparing potentials of adductor canal block in adult patients undergoing arthroscopic medical meniscectomy in the setting of multimodal analgesia. The investigators ultimate goal is to increase the postoperative analgesic time and to preserve quadriceps muscle strength to promote safe and early ambulation.
Detailed description
Peripheral nerve blocks using long-acting local anesthetics are commonly utilized as the sole anesthetic technique or as an adjuvant to general anesthesia for post-operative pain management. However, the duration of sensory block after single dose of long acting local anesthetics is not consistently sufficient to avoid the use of postoperative opioids. Many adjuvants were added to local anesthetics to augment the potency and prolong the duration of peripheral nerve blocks. Alpha-2 adrenoceptor agonists such as clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine. Peri-neural dexmedetomidine was evaluated in animal studies where it prolonged the duration of sensory and motor blocks of local anesthetics without any evidence of neurotoxicity for up to 14 days after initial administration. The effectiveness of perineural dexmedetomidine in augmenting the duration of sensory block of upper limb extremity blocks is based on good quality clinical evidence.
Arthroscopic knee surgery is associated with severe postoperative pain which could be adequately managed by femoral nerve block. However femoral nerve block has been associated with significant motor block and decreased quadriceps muscle strength which may delay ambulation and increase the risk of falling. More recently, adductor canal block (ACB) emerged as a selective motor sparing effective variant of femoral nerve block. Compared with baseline values, the adductor canal block reduces quadriceps muscle strength by 8%, versus 49% for the femoral nerve block. A recent dose finding MRI study reported that 20 ml of local anesthetic is the closest volume to the ED95 for adductor canal block with minimal proximal spread and an estimated success probability of 95.1% (95% credibility interval: 91-98%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineAdductor canal block will be performed before induction of general anesthesia. Patients will be positioned in the supine position with knee slightly flexed and leg externally rotated followed by ultrasound scanning of the middle of thigh using 13-6 MHz linear array probe. The ultrasound probe will be placed over the anterior aspect of the patient's thigh, mid-point between the inguinal crease and medial femoral condyle. The scan will be focused on the femoral artery pulsations aiming to try to visualize the nerves in the adductor canal on both sides (lateral and medial) of the pulsating femoral artery. 20 ml bupivacaine 0.25% combined with 75 mcg dexmedetomidine will be injected. The study solution will be injected underneath the fascia of sartorius muscle. |
| Control group | Placebo comparator | Drug: Normal salineAdductor canal block will be performed before induction of general anesthesia. Patients will be positioned in the supine position with knee slightly flexed and leg externally rotated followed by ultrasound scanning of the middle of thigh using 13-6 MHz linear array probe. The ultrasound probe will be placed over the anterior aspect of the patient's thigh, mid-point between the inguinal crease and medial femoral condyle. The scan will be focused on the femoral artery pulsations aiming to try to visualize the nerves in the adductor canal on both sides (lateral and medial) of the pulsating femoral artery. 20 ml bupivacaine 0.25% combined with 75 mcg dexmedetomidine will be injected. The study solution will be injected underneath the fascia of sartorius muscle. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients of aged (18-45), ASA physical status I or II undergoing arthroscopic medial meniscectomy.
Key exclusion criteria (10 listed)
- Body mass index greater than 35 kg/m2.
- Pregnancy.
- Unstable coronary artery disease, congestive heart failure, or arrhythmias.
- Baseline heart rate (HR) less than 60 beats/min or baseline systolic blood pressure less than 100 mmHg.
- Pre-existing neurological deficits or neuropathy.
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 |
|---|---|---|
| DexmedetomidineAlso: Precedexto investigate the effect of dexmedetomidine on motor and sensory properties of adductor canal block | Drug | Dexmedetomidine group |
| Normal salineAlso: Salineto give normal saline to the other group as a placebo | Drug | Control group |
Primary outcome
Duration of analgesia
Time frame: 24 hours
the time passed till the patient first analgesic request
8 secondary outcomes
richmond agitation sedation scale
Time frame: 24 hours
duration of sensory block
Time frame: 24 hours
onset of sensory block
Time frame: minutes
blood pressure
Time frame: 24 hours
heart rate
Time frame: 24 hours
onset of motor block (by assessment of quadriceps muscle strength)
Time frame: minutes
resting visual analogue score
Time frame: 24 hours
dynamic visual analogue score
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 15 Jan 2019.
- Individual participant dataSharing planned: No
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.
Mohamed Abdulatif, Professor study director
Professor and member of research committee of anesthesia department
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 Dexmedetomidine and Normal saline in people with Arthroscopic Medial Meniscectomy, run by Cairo 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 1 inclusion and 10 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 15 Jan 2019. 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.
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?
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?
Duration of analgesia (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 15 Jan 2019.