Local Wound Infiltration for Tracheal Reconstruction
- Conditions
- Upper Tracheal ResectionTracheal Reconstruction Surgery
- Interventions
- Procedure: Local wound infiltrationProcedure: Superficial cervical plexus block
- Registration Number
- NCT02949661
- 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 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- American Society of Anesthesiologists physical class status I or II
- Undergoing elective upper tracheal resection and reconstruction surgery
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Local wound infiltration Local wound infiltration Patients will receive local wound infiltration with levobupivacaine after the conclusion of surgery Superficial cervical plexus block Superficial cervical plexus block Patients will receive bilateral superficial cervical plexus block using levobupivacaine
- Primary Outcome Measures
Name Time Method Postoperative pain score For 24 hours after surgery Postoperative pain scores will be assessed using postoperative visual analogue score
- Secondary Outcome Measures
Name Time Method Systolic blood pressure For 4 hours after start of surgery Heart rate For 4 hours after start of surgery Bispectral index For 4 hours after start of surgery Peripheral oxygen saturation For 4 hours after start of surgery End-tidal Carbon dioxide tension For 4 hours after start of surgery Duration of analgesia For 24 hours after surgery It is defined as time taken for first analgesic request of analgesia from extubation
Cumulative analgesic consumption For 24 hours after surgery total analgesics used for 24 hrs after surgery
Diastolic blood pressure For 4 hours after start of surgery Cortisol serum before induction ,one hour after start of surgery and one hour after end of surgery Plasma cortisol assay