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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06621836
Enrollment
51
Registered
2024-10-01
Start date
2024-01-01
Completion date
2024-09-15
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Plexus Block

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.

Interventions

DRUGICPB 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

DRUGICPB - 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The duration of analgesiaTime elapsed from the end of the ICPB block procedure till VAS ≥ 4 over 24 hours

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026