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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03426527
Enrollment
80
Registered
2018-02-08
Start date
2018-03-01
Completion date
2018-10-01
Last updated
2020-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheal Reconstruction

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.

Interventions

DRUGLevobupivacaine

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

DRUGLevobupivacaine-Dexmedetomidine

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

OTHERGeneral Anaesthesia

Using propofol, fentanyl and atracurium

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cumulative postoperative opioid consumptionFor 24 hours after surgeryTotal postoperative opioid consumption

Secondary

MeasureTime frameDescription
End-tidal carbon dioxide tensionBefore and for 6 hours after start of anaesthesiaPerioperative changes in end-tidal carbon dioxide tension
Systolic blood pressureBefore and for 6 hours after start of anaesthesiaPerioperative changes in systolic blood pressure
Diastolic blood pressureBefore and for 6 hours after start of anaesthesiaPerioperative changes in diastolic blood pressure
Peripheral oxygen saturationBefore and for 6 hours after start of anaesthesiaPerioperative changes in peripheral oxygen saturation
Time for first analgesic request of analgesia following extubationFor 24 hours after surgeryTime to receiving the rescue analgesic following surgery
Pain scoresFor 24 hours after surgeryUsing visual analogue score (it is 100 mm unmarked line in which 0 = no pain and 100 = worst pain),score \>30 mm needs rescue analgesics
Cortisol serum levelbefore induction of anaesthesia , one hour after the block then one hour after recoveryPerioperative changes in cortisol level
Heart rateBefore and for 6 hours after start of anaesthesiaPerioperative changes in heart rate

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026