Local Wound Infiltration for Tracheal Reconstruction

NCT02949661 | Withdrawn DMC

• 1 other identifier: R ∕16.08.18
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Upper Tracheal Resection; Tracheal Reconstruction Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative pain score

  Postoperative pain scores will be assessed using postoperative visual analogue score

  For 24 hours after surgery

Secondary Outcomes (9)

• 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

Study Arms (2)

Superficial cervical plexus block

EXPERIMENTAL

Patients will receive bilateral superficial cervical plexus block using levobupivacaine

Procedure: Superficial cervical plexus block

Local wound infiltration

ACTIVE COMPARATOR

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

Procedure: Local wound infiltration

Interventions

Superficial cervical plexus block PROCEDURE

Patients will receive bilateral superficial cervical plexus block

Superficial cervical plexus block

Local wound infiltration PROCEDURE

Patients will receive local wound infiltration

Local wound infiltration

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Officials

• Hanaa M Elbendary, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: October 31, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 11, 2020

Record last verified: 2020-09