Clinical trial NCT03426527: Dexmedetomidine for Bilateral Superficial Cervical Plexus Block for Reconstructive Tracheal Surgery
Official title: Levobupivacaine Versus Levobupivacaine - Dexmedetomidine for Ultrasound Guided Bilateral Superficial Cervical Plexus Block for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Reconstruction
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with tracheal stenosis or tracheal tumors .The post intubation tracheal stenosis is the common indication for (TRR).The immediate postoperative period can be anxiety provoking for some reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which inadequately treated.

Bilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia technique for its feasibility and efficacy. The use of regional anesthesia in combination with general anesthesia may lighten the level of general anesthesia required , provide prolonged postoperative analgesia and reduce the requirements for opioid analgesics

Dexmedetomidine is a highly selective α2 agonist with high affinity for α2 adrenergic receptors and less α1 effects, which is responsible for the hypnotic and analgesic effects. Previous trials demonstrated that perineural dexmedetomidine in combination with bupivacaine enhanced sensory and motor block ,without neurotoxicity ,in both experimental and clinical studies.

Levobupivacaine, is "S"-enantiomer of bupivacaine, has strongly emerged as a safer alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be equally efficacious as bupivacaine, but with a superior pharmacokinetic profile.

Clinically, levobupivacaine has been observed to be well tolerated in regional anesthesia techniques both after bolus administration and continuous post-operative infusion.

Detailed description: The aim of this study is to evaluate the intra- and postoperative efficacy of levobupivacaine versus levobupivacaine - dexmedetomidine for superficial cervical plexus block for upper tracheal resection and reconstruction surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I or II.

Exclusion Criteria:

* History of allergy to the drugs used
* Coagulation disorders
* Pregnancy
* Postpartum period.
* Lactating females
* Local sepsis

Primary outcomes:
measure: Cumulative postoperative opioid consumption
timeFrame: For 24 hours after surgery
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: Before and for 6 hours after start of anaesthesia
measure: Diastolic blood pressure
timeFrame: Before and for 6 hours after start of anaesthesia
measure: Heart rate
timeFrame: Before and for 6 hours after start of anaesthesia
measure: Peripheral oxygen saturation
timeFrame: Before and for 6 hours after start of anaesthesia
measure: End-tidal carbon dioxide tension
timeFrame: Before and for 6 hours after start of anaesthesia
measure: Time for first analgesic request of analgesia following extubation
timeFrame: For 24 hours after surgery
measure: Pain scores
timeFrame: For 24 hours after surgery
measure: Cortisol serum level
timeFrame: before induction of anaesthesia , one hour after the block then one hour after recovery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University, Central Hospital, Oto-Rhino-Laryngology anesthesia Unit
state: DK
Study officials:
affiliation: Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt.
name: Salwa MS Hayes, MD
role: STUDY_CHAIR
References: