Efficacy of Ultrasound Guided Superficial Cervical Plexus Block for Tracheal Reconstruction Surgery:

NCT04567992 | Completed DMC

• 1 other identifier: MS-106-2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The essential goal for tracheal reconstruction is is the ability of the anaesthesiologist and surgeon to maintain control of the airway at all times. In the postoperative period the patient should maintain a flexed neck position to avoid any traction on the tracheal anastomosis. Thus, pain control is essential postoperatively so that patients will be awake and cooperative to maintain this position. \[1\]. Superficial cervical plexus block can be used in a variety of surgical procedures , including superficial surgery on the neck and shoulders and thyroid surgery as it results in anesthesia of the skin of the anterolateral neck and the ante-auricular and retro-auricular areas, as well as the skin overlying and immediately inferior to the clavicle on the chest wall Figures 1 and 6)\[2\]. Thus it can be used as an adjuvant to general anaesthesia to provide analgesia for patients undergoing tracheal resection and anastomosis to keep the patients awake and cooperative at the conclusion of the procedure. The goal of the ultrasound (US)-guided technique of SCB is to deposit local anesthetic within the vicinity of the sensory branches of the nerve roots C2, C3, and C4 which combine to form the four terminal branches (the lesser occipital, greater auricular, transverse cervical, and supraclavicular nerves) and emerge from behind the posterior border of the SCM. Advantages over the landmark-based technique include the ability to visualize the spread of local anesthetic in the correct plane, which therefore increases the success rate, and to avoid a needle insertion that is too deep and the inadvertent puncture of neighboring structures\[3\]. Aim of the work To assess the efficiency of using ultrasound-guided SCB for providing intra and postoperative analgesia for patients undergoing tracheal resection and anastomosis under general anaesthesia.

Conditions

Efficiency of Using Ultrasound-guided SCB for Providing Intra and Postoperative Analgesiatracheal Reconstruction Surgery

Outcome Measures

Primary Outcomes (1)

• quality of recovery using quality of recovery 40 qusetionnaire

  total score of Qor-40 (total score of 200) with highest indicates better outcome

  first 24 hour

Secondary Outcomes (2)

• post operative morphine consumption

  24 hour

• visual analogue scale post-operative

  first 24 hour

Study Arms (2)

SCPB

EXPERIMENTAL

Procedure: superficial cervical plexus block

Control

PLACEBO COMPARATOR

Procedure: superficial cervical plexus block

Interventions

superficial cervical plexus block PROCEDURE

ultrasound guided injection of local anaesthesia in the superficial cervical plexus

Also known as: Drug:, Bupivicaine

Control; SCPB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I, II, and III adult patients undergoing elective tracheal resection and anastomosis under general anaesthesia were included.

You may not qualify if:

• Coagulation disorders
• Pregnancy.
• Age less than 18 years.
• Patient refusal.
• Emergency re-operation within

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr alainy medical school

Cairo, 12566, Egypt

Location

MeSH Terms

Interventions

Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anaesthesia, SICU and pain management

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 29, 2020
• Study Start: November 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: February 14, 2022

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)