Local Wound Infiltration for Tracheal Reconstruction

Mansoura University

Status: Withdrawn

Conditions: Upper Tracheal Resection; Tracheal Reconstruction Surgery

Treatments: Procedure: Local wound infiltration; Procedure: Superficial cervical plexus block

Study type: Interventional

Funder types: Other

Identifiers

NCT02949661

R ∕16.08.18

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Superficial cervical plexus block

Experimental group

Description:

Patients will receive bilateral superficial cervical plexus block using levobupivacaine

Treatment:

Procedure: Superficial cervical plexus block

Local wound infiltration

Active Comparator group

Description:

Patients will receive local wound infiltration with levobupivacaine after the conclusion of surgery

Treatment:

Procedure: Local wound infiltration