Dexmedetomidine for Bilateral Superficial Cervical Plexus Block for Reconstructive Tracheal Surgery

Levobupivacaine Versus Levobupivacaine - Dexmedetomidine for Ultrasound Guided Bilateral Superficial Cervical Plexus Block for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Tracheal Reconstruction
• Intervention / Treatment: Drug: Levobupivacaine; Other: General Anaesthesia; Drug: Levobupivacaine-Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Mansoura University, Central Hospital, Oto-Rhino-Laryngology anesthesia Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Levobupivacaine; Patients will receive bilateral superficial cervical plexus block using levobupivacaine General anesthesia	Drug: Levobupivacaine; Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine; Other: General Anaesthesia; Using propofol, fentanyl and atracurium
Active Comparator: Levobupivacaine-Dexmedetomidine; Patients will receive bilateral superficial cervical plexus block using levobupivacaine-dexmedetomidine General anesthesia	Other: General Anaesthesia; Using propofol, fentanyl and atracurium; Drug: Levobupivacaine-Dexmedetomidine; Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine in conjunction with dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative postoperative opioid consumption	Total postoperative opioid consumption	For 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	Perioperative changes in systolic blood pressure	Before and for 6 hours after start of anaesthesia
Diastolic blood pressure	Perioperative changes in diastolic blood pressure	Before and for 6 hours after start of anaesthesia
Heart rate	Perioperative changes in heart rate	Before and for 6 hours after start of anaesthesia
Peripheral oxygen saturation	Perioperative changes in peripheral oxygen saturation	Before and for 6 hours after start of anaesthesia
End-tidal carbon dioxide tension	Perioperative changes in end-tidal carbon dioxide tension	Before and for 6 hours after start of anaesthesia
Time for first analgesic request of analgesia following extubation	Time to receiving the rescue analgesic following surgery	For 24 hours after surgery
Pain scores	Using visual analogue score (it is 100 mm unmarked line in which 0 = no pain and 100 = worst pain),score >30 mm needs rescue analgesics	For 24 hours after surgery
Cortisol serum level	Perioperative changes in cortisol level	before induction of anaesthesia , one hour after the block then one hour after recovery

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Salwa MS Hayes, MD, Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Levobupivacaine
• Other Study ID Numbers: R/17.09.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No