Clinical trial NCT02949661: Local Wound Infiltration for Tracheal Reconstruction
Official title: Local Wound Infiltration Versus Bilateral Superficial Cervical Plexus Block With Levobupivacaine for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Upper Tracheal Resection
Tracheal Reconstruction Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with tracheal stenosis or tracheal tumors .The postintubation 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

Local anesthetic infiltration into the surgical incision can relieve pain at the wound site after surgery, as part of multimodal analgesic approach.

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 local wound infiltration versus bilateral superficial cervical plexus block with levobupivacaine for upper tracheal resection and reconstruction surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical class status I or II
* Undergoing elective upper tracheal resection and reconstruction surgery

Exclusion Criteria:

* Age less than18 years
* Patients with preoperative medication included opioid
* History of allergy to the drugs used
* Coagulation disorders
* Pregnancy
* Patient refusal
* Local sepsis
* Inability to understand the study protocol or pain scale.

Primary outcomes:
measure: Postoperative pain score
timeFrame: For 24 hours after surgery
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: For 4 hours after start of surgery
measure: Diastolic blood pressure
timeFrame: For 4 hours after start of surgery
measure: Heart rate
timeFrame: For 4 hours after start of surgery
measure: Peripheral oxygen saturation
timeFrame: For 4 hours after start of surgery
measure: End-tidal Carbon dioxide tension
timeFrame: For 4 hours after start of surgery
measure: Bispectral index
timeFrame: For 4 hours after start of surgery
measure: Duration of analgesia
timeFrame: For 24 hours after surgery
measure: Cumulative analgesic consumption
timeFrame: For 24 hours after surgery
measure: Cortisol serum
timeFrame: before induction ,one hour after start of surgery and one hour after end of surgery
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
name: Hanaa M Elbendary, MD
role: STUDY_CHAIR
References: