Mansoura University, Central Hospital, Oto-Rhino-Laryngology anesthesia Unit
Al Mansurah, DK, 050, Egypt
NCT Number: NCT03426527
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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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Al Mansurah, DK, 050, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine
Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine in conjunction with dexmedetomidine
Using propofol, fentanyl and atracurium
Time frame: For 24 hours after surgery
Total postoperative opioid consumption
Time frame: Before and for 6 hours after start of anaesthesia
Perioperative changes in systolic blood pressure
Time frame: Before and for 6 hours after start of anaesthesia
Perioperative changes in diastolic blood pressure
Time frame: Before and for 6 hours after start of anaesthesia
Perioperative changes in heart rate
Time frame: Before and for 6 hours after start of anaesthesia
Perioperative changes in peripheral oxygen saturation
Time frame: Before and for 6 hours after start of anaesthesia
Perioperative changes in end-tidal carbon dioxide tension
Time frame: For 24 hours after surgery
Time to receiving the rescue analgesic following surgery
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
Time frame: before induction of anaesthesia , one hour after the block then one hour after recovery
Perioperative changes in cortisol level
Mansoura University
Other
Levobupivacaine Versus Levobupivacaine - Dexmedetomidine for Ultrasound Guided Bilateral Superficial Cervical Plexus Block for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia
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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.