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Completed

NCT Number: NCT03426527

Dexmedetomidine for Bilateral Superficial Cervical Plexus Block for Reconstructive Tracheal Surgery

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levobupivacaine

Drug

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

Levobupivacaine-Dexmedetomidine

Drug

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

General Anaesthesia

Other

Using propofol, fentanyl and atracurium

Primary outcomes

  1. Cumulative postoperative opioid consumption

    Time frame: For 24 hours after surgery

    Total postoperative opioid consumption

Secondary outcomes

  1. Systolic blood pressure

    Time frame: Before and for 6 hours after start of anaesthesia

    Perioperative changes in systolic blood pressure

  2. Diastolic blood pressure

    Time frame: Before and for 6 hours after start of anaesthesia

    Perioperative changes in diastolic blood pressure

  3. Heart rate

    Time frame: Before and for 6 hours after start of anaesthesia

    Perioperative changes in heart rate

  4. Peripheral oxygen saturation

    Time frame: Before and for 6 hours after start of anaesthesia

    Perioperative changes in peripheral oxygen saturation

  5. End-tidal carbon dioxide tension

    Time frame: Before and for 6 hours after start of anaesthesia

    Perioperative changes in end-tidal carbon dioxide tension

  6. Time for first analgesic request of analgesia following extubation

    Time frame: For 24 hours after surgery

    Time to receiving the rescue analgesic following surgery

  7. Pain scores

    Time frame: For 24 hours after surgery

    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

  8. Cortisol serum level

    Time frame: before induction of anaesthesia , one hour after the block then one hour after recovery

    Perioperative changes in cortisol level

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 8, 2018
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.