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Completed

NCT Number: NCT03030950

Perineural Dexmedetomidine in Adductor Canal Block

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Cairo, Egypt

About this study

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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients of aged (18-45), ASA physical status I or II undergoing arthroscopic medial meniscectomy.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Dexmedetomidine

Drug

to investigate the effect of dexmedetomidine on motor and sensory properties of adductor canal block

Other names: Precedex

normal saline

Drug

to give normal saline to the other group as a placebo

Other names: Saline

Primary outcomes

  1. Duration of analgesia

    Time frame: 24 hours

    the time passed till the patient first analgesic request

Secondary outcomes

  1. richmond agitation sedation scale

    Time frame: 24 hours

    A scale to assess the patient sedation and agitation

  2. duration of sensory block

    Time frame: 24 hours

    The time needed to regain the patient sensation

  3. onset of sensory block

    Time frame: minutes

    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

  4. blood pressure

    Time frame: 24 hours

    mmHg

  5. heart rate

    Time frame: 24 hours

    beat per minutes

  6. onset of motor block (by assessment of quadriceps muscle strength)

    Time frame: minutes

    The maximum voluntary isometric contraction (MVIC) of the quadriceps femoris muscle will be measured using a handheld dynamometer

  7. resting visual analogue score

    Time frame: 24 hours

    the grade of pain during rest as experienced by the patient, rated from 0 to 10

  8. dynamic visual analogue score

    Time frame: 24 hours

    the grade of pain with movement as experienced by the patient, rated from 0 to 10

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effects of Peri-neural Dexmedetomidine on the Pharmacodynamic Profile of Bupivacaine-induced Adductor Canal Block in Patients Undergoing Arthroscopic Medial Meniscectomy

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2017
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.