Analgesic Efficacy of Intermediate Cervical Plexus Block in Patients Undergoing Neck Surgeries: A Comparison Between Two Bupivacaine Concentrations

NCT06621836 | Completed Phase 4

• 1 other identifier: MS-425-2023
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical plexus blocks (CPB) have been widely used to provide effective anesthesia and analgesia during various head and neck procedures. The ICPB was considered a good alternative to the deep CPB with an easier technique and fewer adverse events such as intravascular, epidural, subarachnoid injection, and phrenic nerve palsy. A recent randomized trial investigated the analgesic efficacy of superficial vs intermediate CPB combined with GA during total thyroidectomy. Authors used 10 ml bupivacaine 0.25% bilaterally, and they revealed a lower pain score and prolonged duration of analgesia with ICPB compared to superficial CPB; however, the authors did not assess the influence of this bupivacaine concentration on the diaphragmatic motion. \[5\] This randomized comparative trial is designed to investigate the analgesic efficacy of ICPB combined GA using two bupivacaine concentrations in patients undergoing neck surgeries (total thyroidectomy or total laryngectomy). We hypothesize that a smaller concentration of bupivacaine (0.185%) could provide an equivalent analgesic effect to a larger concentration (0.25%) with less impact on the diaphragmatic motion. The primary endpoint is the duration of postoperative analgesia. The secondary endpoints are the intraoperative hemodynamics, the postoperative pain score, total postoperative opioid consumption over 24 hours, diaphragmatic motions, and hemi-diaphragmic paresis.

Conditions

Cervical Plexus Block

Outcome Measures

Primary Outcomes (1)

• The duration of analgesia

  Time elapsed from the end of the ICPB block procedure till VAS ≥ 4 over 24 hours

Study Arms (2)

Group-H

ACTIVE COMPARATOR

Drug: ICPB H

Group-L

ACTIVE COMPARATOR

Drug: ICPB - L

Interventions

ICPB H DRUG

ICPB technique The patient's head will be rested on a pillow and turned to the opposite side. A linear probe with higher frequencies will be placed transversely over the midpoint of the SCM muscle. The carotid artery will be identified and traced upwards to its bifurcation. the probe will be then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle will be advanced underneath the investing fascia of SCM muscle and above the interscalene groove until feeling the "pop" on piercing the investing fascia. The patient will be then randomly allocated into two groups (H \& L) using computer-generated random numbers that will be concealed in opaque envelopes. Group H will receive 10 ml 0.25 % bupivacaine he technique will be repeated on the opposite side

Group-H

ICPB - L DRUG

ICPB technique The patient's head will be rested on a pillow and turned to the opposite side. A linear probe with higher frequencies will be placed transversely over the midpoint of the SCM muscle. The carotid artery will be identified and traced upwards to its bifurcation. the probe will be then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle will be advanced underneath the investing fascia of SCM muscle and above the interscalene groove until feeling the "pop" on piercing the investing fascia. The patient will be then randomly allocated into two groups (H \& L) using computer-generated random numbers that will be concealed in opaque envelopes. Group L will receive 10 ml 0.125% bupivacaine. The technique will be repeated on the opposite side

Group-L

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-III,
• scheduled for total thyroidectomy or total laryngectomy

You may not qualify if:

• Heart failure,
• A history of arrhythmias or treatment with antiarrhythmic drugs,
• Impaired pulmonary, liver or kidney functions,
• Neck infection or rash

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Anesthesia department - Faculty of medicine- Cairo University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: October 1, 2024
• Study Start: January 1, 2024
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

EG (1)