Skip to main content
OpenTrials
Completed

NCT Number: NCT06621836

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Plexus Block

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anesthesia department - Faculty of medicine- Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

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

Primary outcomes

  1. The duration of analgesia

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.