Dexmedetomidine for Bilateral Superficial Cervical Plexus Block for Reconstructive Tracheal Surgery
- Conditions
- Tracheal Reconstruction
- Interventions
- Registration Number
- NCT03426527
- Lead Sponsor
- Mansoura University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- American Society of Anesthesiologists physical status I or II.
- History of allergy to the drugs used
- Coagulation disorders
- Pregnancy
- Postpartum period.
- Lactating females
- Local sepsis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Levobupivacaine Levobupivacaine Patients will receive bilateral superficial cervical plexus block using levobupivacaine General anesthesia Levobupivacaine General Anaesthesia Patients will receive bilateral superficial cervical plexus block using levobupivacaine General anesthesia Levobupivacaine-Dexmedetomidine Levobupivacaine-Dexmedetomidine Patients will receive bilateral superficial cervical plexus block using levobupivacaine-dexmedetomidine General anesthesia Levobupivacaine-Dexmedetomidine General Anaesthesia Patients will receive bilateral superficial cervical plexus block using levobupivacaine-dexmedetomidine General anesthesia
- Primary Outcome Measures
Name Time Method Cumulative postoperative opioid consumption For 24 hours after surgery Total postoperative opioid consumption
- Secondary Outcome Measures
Name Time Method Diastolic blood pressure Before and for 6 hours after start of anaesthesia Perioperative changes in diastolic blood pressure
Heart rate Before and for 6 hours after start of anaesthesia Perioperative changes in heart rate
Systolic blood pressure Before and for 6 hours after start of anaesthesia Perioperative changes in systolic blood pressure
Pain scores 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
Peripheral oxygen saturation Before and for 6 hours after start of anaesthesia Perioperative changes in peripheral oxygen saturation
Cortisol serum level before induction of anaesthesia , one hour after the block then one hour after recovery Perioperative changes in cortisol level
End-tidal carbon dioxide tension Before and for 6 hours after start of anaesthesia Perioperative changes in end-tidal carbon dioxide tension
Time for first analgesic request of analgesia following extubation For 24 hours after surgery Time to receiving the rescue analgesic following surgery
Trial Locations
- Locations (1)
Mansoura University, Central Hospital, Oto-Rhino-Laryngology anesthesia Unit
🇪🇬Mansourah, DK, Egypt