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COMPLETED
NCT06621836
PHASE4

Analgesic Efficacy of Intermediate Cervical Plexus Block in Patients Undergoing Thyroid Surgeries Using Two Bupivacaine Concentrations Non Inferiority Trial

Sponsor: Cairo University

View on ClinicalTrials.gov

Summary

Cervical plexus blocks (CPB) have been widely used to provide effective anesthesia and analgesia during thyroid surgeries. 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. The authors used 10 mL of 0.25% bupivacaine 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 diaphragmatic motion. \[5\] This randomized comparative trial is designed to investigate the analgesic efficacy of ICPB combined with GA using two bupivacaine concentrations in patients undergoing thyroid surgery. 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 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.

Official title: Analgesic Efficacy of Intermediate Cervical Plexus Block in Patients Undergoing Thyroid Surgeries Using Two Bupivacaine Concentrations. Non-inferiority Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

51

Start Date

2025-01-01

Completion Date

2026-08-01

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

DRUG

ICPB H

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

DRUG

ICPB - L

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

Locations (1)

Anesthesia department - Faculty of medicine- Cairo University

Cairo, Egypt