Dexmedetomidine for Bilateral Superficial Cervical Plexus Block for Reconstructive Tracheal Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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 |
Drug: Levobupivacaine-Dexmedetomidine
Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine in conjunction with dexmedetomidine
Other: General Anaesthesia
Using propofol, fentanyl and atracurium
|
Outcome Measures
Primary Outcome Measures
- Cumulative postoperative opioid consumption [For 24 hours after surgery]
Total postoperative opioid consumption
Secondary Outcome Measures
- Systolic blood pressure [Before and for 6 hours after start of anaesthesia]
Perioperative changes in systolic blood pressure
- 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
- Peripheral oxygen saturation [Before and for 6 hours after start of anaesthesia]
Perioperative changes in peripheral oxygen saturation
- 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
- 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
- Cortisol serum level [before induction of anaesthesia , one hour after the block then one hour after recovery]
Perioperative changes in cortisol level
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mansoura University, Central Hospital, Oto-Rhino-Laryngology anesthesia Unit | Mansourah | DK | Egypt | 050 |
Sponsors and Collaborators
- Mansoura University
Investigators
- Study Chair: Salwa MS Hayes, MD, Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R/17.09.19