Bilateral Ultrasound Guided Superficial Cervical Plexus Block After Thyroid Surgery

NCT05476003 | Unknown

• 1 other identifier: 34751/6/21
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluating ultrasound guided Bilateral Superficial Cervical Plexus Block as a part of enhanced recovery after thyroid surgery using Quality of Recovery-15 scale as a method for assessment of quality of recovery.

Conditions

Bilateral Ultrasound Guided Superficial Cervical Plexus Block; Thyroid Surgery; Enhanced Recovery

Outcome Measures

Primary Outcomes (1)

• Quality of recovery

  Improvement of the quality of recovery assessed using the 15-item quality of recovery questionnaire. The Quality of Recovery-15 included 15 items 1-Breathing 2-Food 3-Rest 4-Sleep 5-Hygiene 6-Communication 7-Support 8-Return to work 9-Feeling comfortable and in control 10-Feeling of general well-being 10-Moderate pain 12-Severe pain 13-Nausea/Vomitting 14-Worry/Anxiety 15-Feeling sad or depressed . Each item will be assessed using a10-point numerical rating scale. The total score of Quality of Recovery-15 ranges from 0 (extremely poor recovery) to 150 (all excellent recovery).

  24 hours postoperatively.

Secondary Outcomes (3)

• Postoperative analgesia

  24 hours postoperatively

• Opioid consumption

  24 hours postoperatively

• Diaphragmatic Excursion

  24 hours postoperatively

Study Arms (2)

Sham Technique

SHAM COMPARATOR

Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of 10 ml normal saline bilaterally.

Procedure: Ultrasound-guided Bilateral superficial cervical plexus block; Drug: Midazolam

Ultrasound-guided Bilateral superficial cervical plexus block

ACTIVE COMPARATOR

Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of total volume 10 ml containing Bupivacaine 0.25% (5 ml Bupivacaine 0.5 % and 5 ml normal saline).

Procedure: Ultrasound-guided Bilateral superficial cervical plexus block; Drug: Midazolam

Interventions

Midazolam DRUG

All patients will be premedicated with Midazolam (0.02mg/Kg).

Sham Technique; Ultrasound-guided Bilateral superficial cervical plexus block

Ultrasound-guided Bilateral superficial cervical plexus block PROCEDURE

This nerve block is typically performed in the supine or semi-sitting position, with the head turned slightly away from the side to be blocked to facilitate operator access. Under strict aseptic condition, the linear ultrasound transducer should be placed on the lateral neck, overlying the sternocleidomastoid muscle at the level of its midpoint (approximately the level of the cricoid cartilage). Once the sternocleidomastoid muscle has been identified, the transducer is moved posteriorly until the tapering posterior edge is positioned in the middle of the screen. Once the plexus has been identified and using In-Plane approach, the needle is passed from medial to lateral through the skin, platysma and investing layer of deep cervical fascia and the tip is placed adjacent to the plexus. Following negative aspiration, 1 mL of local anesthetic is injected to confirm the proper injection site. The remainder of the local anesthetic (5ml) is administered to envelop the plexus.

Sham Technique; Ultrasound-guided Bilateral superficial cervical plexus block

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 21 to 65 years
• American Society of Anesthesiologists physical status I or II.
• Scheduled for elective thyroid surgery.

You may not qualify if:

• Patient refusal to participate.
• Patients with history of allergy to local anesthetics.
• Patients with history of chronic use of pain killers .
• Patients presented with mental dysfunction.
• Patients with coagulation disorders.
• Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
• Patients with Chronic Obstructive Pulmonary Disease or Body Mass Index more than 40.

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All blocks will be performed by the same anesthesiologist while the measurements will be recorded by anesthesiologist who has no idea about patient allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: July 27, 2022
• Study Start: August 15, 2022
• Primary Completion: August 15, 2023
• Study Completion: September 15, 2023
• Last Updated: August 1, 2022

Record last verified: 2022-07