Dexmedetomidine for Bilateral Superficial Cervical Plexus Block for Reconstructive Tracheal Surgery

Mansoura University

Status: Completed

Conditions: Tracheal Reconstruction

Treatments: Drug: Levobupivacaine; Drug: Levobupivacaine-Dexmedetomidine; Other: General Anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03426527

R/17.09.19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Levobupivacaine

Placebo Comparator group

Description:

Patients will receive bilateral superficial cervical plexus block using levobupivacaine General anesthesia

Treatment:

Other: General Anaesthesia

Drug: Levobupivacaine

Levobupivacaine-Dexmedetomidine

Active Comparator group

Description:

Patients will receive bilateral superficial cervical plexus block using levobupivacaine-dexmedetomidine General anesthesia

Treatment:

Other: General Anaesthesia

Drug: Levobupivacaine-Dexmedetomidine