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

Efficacy of Ultrasound Guided Superficial Cervical Plexus Block for Tracheal Reconstruction Surgery on Quality of Recovery: a Randomized Control Study

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.

Study Overview

• Status: Completed
• Conditions: Efficiency of Using Ultrasound-guided SCB for Providing Intra and Postoperative Analgesiatracheal Reconstruction Surgery
• Intervention / Treatment: Procedure: superficial cervical plexus block

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12566
    • Kasr Alainy Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Procedure: superficial cervical plexus block; ultrasound guided injection of local anaesthesia in the superficial cervical plexus; Other Names: Bupivicaine; Drug:
Experimental: SCPB	Procedure: superficial cervical plexus block; ultrasound guided injection of local anaesthesia in the superficial cervical plexus; Other Names: Bupivicaine; Drug:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative morphine consumption	post operative morphine consumption	24 hour
visual analogue scale post-operative	visual analogue scale post-operative	first 24 hour

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 26, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: MS-106-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No