An interventional study of Intra-articular dexmedetomidine and Intravenous dexmedetomidine in Knee Arthroscopy, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-09-22.
Sponsored by Mansoura University · Not applicable, Interventional, and Supportive care
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.
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.
Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Patients will be subjected for elective knee arthroscopy under local anesthesia (Intra-articular dexmedetomidine + Intra-articular bupivacaine).
Drug: Intra-articular dexmedetomidine
patients will be subjected for elective knee arthroscopy under local anesthesia (i.v. dexmedetomidine + Intra-articular bupivacaine).
Drug: Intravenous dexmedetomidine
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
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.
Pain scores
Pain will be assessed using 10 cm visual analogue scale (VAS)
Time frame: for 24 hours starting immediately before performing the procedure
Heart rate
Time frame: starting immediately before performing the procedure
Blood pressure
Changes in systolic and mean blood pressure
Time frame: starting immediately before performing the procedure
Oxygen saturation
Changes in peripheral oxygen saturation
Time frame: starting immediately before performing the procedure
Respiratory rate
Changes in respiratory rates will be recorded
Time frame: starting immediately before performing the procedure
Level of sedation
will be evaluated using the following scale: (5= awake/alert to 0= asleep/unarousable )
Time frame: 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
Time frame: 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
Time frame: For 24 hours after performing the injection
Intraoperative and postoperative side effects
These include nausea, vomiting, hypotension, bradycardia, respiratory depression, Hypertension
Time frame: For 24 hours after performing the injection
Time to mobilization out of bed
will be recorded in minutes from skin closure
Time frame: 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
Time frame: For 4 hours after surgery
Plan to share: Undecided
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Mansoura University