Dexmedetomidine for Bilateral Superficial Cervical Plexus Block for Reconstructive Tracheal Surgery

NCT ID: NCT03426527

Last Updated: 2020-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2018-10-01

Brief Summary

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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

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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.

Conditions

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Tracheal Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Levobupivacaine

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

Group Type PLACEBO_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine

General Anaesthesia

Intervention Type OTHER

Using propofol, fentanyl and atracurium

Levobupivacaine-Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Levobupivacaine-Dexmedetomidine

Intervention Type DRUG

Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine in conjunction with dexmedetomidine

General Anaesthesia

Intervention Type OTHER

Using propofol, fentanyl and atracurium

Interventions

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Levobupivacaine

Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine

Intervention Type DRUG

Levobupivacaine-Dexmedetomidine

Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine in conjunction with dexmedetomidine

Intervention Type DRUG

General Anaesthesia

Using propofol, fentanyl and atracurium

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Salwa MS Hayes, MD

Role: STUDY_CHAIR

Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt.

Locations

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Mansoura University, Central Hospital, Oto-Rhino-Laryngology anesthesia Unit

Al Mansurah, DK, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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R/17.09.19

Identifier Type: -

Identifier Source: org_study_id

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