Dexmedetomidine for Bilateral Superficial Cervical Plexus Block for Reconstructive Tracheal Surgery

M

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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