Local Wound Infiltration for Tracheal Reconstruction

NCT ID: NCT02949661

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-05-31

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.

Conditions

Upper Tracheal Resection; Tracheal Reconstruction Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Superficial cervical plexus block

Patients will receive bilateral superficial cervical plexus block using levobupivacaine

Group Type: EXPERIMENTAL

Superficial cervical plexus block

Intervention Type: PROCEDURE

Patients will receive bilateral superficial cervical plexus block

Local wound infiltration

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

Group Type: ACTIVE_COMPARATOR

Local wound infiltration

Intervention Type: PROCEDURE

Patients will receive local wound infiltration

Interventions

Superficial cervical plexus block

Patients will receive bilateral superficial cervical plexus block

Intervention Type: PROCEDURE

Local wound infiltration

Patients will receive local wound infiltration

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanaa M Elbendary, MD

Role: STUDY_CHAIR

Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

Other Identifiers

R ∕16.08.18

Identifier Type: -

Identifier Source: org_study_id