Local Wound Infiltration for Tracheal Reconstruction

Local Wound Infiltration Versus Bilateral Superficial Cervical Plexus Block With Levobupivacaine for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia.

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.

Study Overview

• Status: Withdrawn
• Conditions: Upper Tracheal Resection; Tracheal Reconstruction Surgery
• Intervention / Treatment: Procedure: Superficial cervical plexus block; Procedure: Local wound infiltration

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Superficial cervical plexus block; Patients will receive bilateral superficial cervical plexus block using levobupivacaine	Procedure: Superficial cervical plexus block; Patients will receive bilateral superficial cervical plexus block
Active Comparator: Local wound infiltration; Patients will receive local wound infiltration with levobupivacaine after the conclusion of surgery	Procedure: Local wound infiltration; Patients will receive local wound infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain score	Postoperative pain scores will be assessed using postoperative visual analogue score	For 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure		For 4 hours after start of surgery
Diastolic blood pressure		For 4 hours after start of surgery
Heart rate		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
Bispectral index		For 4 hours after start of surgery
Duration of analgesia	It is defined as time taken for first analgesic request of analgesia from extubation	For 24 hours after surgery
Cumulative analgesic consumption	total analgesics used for 24 hrs after surgery	For 24 hours after surgery
Cortisol serum	Plasma cortisol assay	before induction ,one hour after start of surgery and one hour after end of surgery

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Hanaa M Elbendary, MD, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2016
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: R ∕16.08.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED