NCT07241364

Brief Summary

We aimed to evaluate the analgesic effect of ultrasound guided Superficial cervical plexux block in tympanomastoid ear surgeries by comparing it with conventional general anaesthesia using systemic analgesic through observation of intra- and postoperative requirements of the total dose of systemic analgesics, visual analog scale (VAS) score, total duration of analgesia, vital parameters and the occurrence of any perioperative complications.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

cervical plexus blockhypotensive anesthesiaear surgery

Outcome Measures

Primary Outcomes (2)

  • pain

    monitoring pain score using visual analog score (VAS) postoperative . to evaluate the analgesic effect

    24 hours

  • analgesia

    The number of analgesic doses required for each patient as rescue analgesia (when VAS \> 3), will be recorded and statistically compared between the two groups

    24 hours

Study Arms (2)

control group

NO INTERVENTION

will receive only conventional general anasthesia in ear surgery

study group

EXPERIMENTAL

patients will receive superficial cervical plexus block in addittion to general anesthesia

Procedure: nerve block with bupivacaine 0.25%

Interventions

superficial cervical plexus block (superficial CPB ) will be administered in a supine position with the head turned opposite to the side of the block using ultrasound guidance . Local anaesthetic will be injected alongside the posterior border of the muscle 2-3 cm in cranial and caudal directions. Using a 'fan' technique, the local anaesthetic will be administered subcutaneously and behind the sternocleidomastoid muscle. Ten millilitres of 0.25% bupivacaine were injected for each side of the block using a 1.5-inch 24-gauge needle..

study group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders. 2- Age between 20 -40 years. 3- ASA 1 \& 2 physical status. 4- Patients undergoing simple ear surgery as Tympano-mastoidectomy

You may not qualify if:

  • Infection at or near the injection site. 2- Uncontrolled preoperative hypertension. 3- age \< 20 or \>40 4- chronic opoid abuse patients. 5- patients with pre existing neuropathy or other neurological diseases. 6- patients on anticoagulation. 7- plt count \< 100 or INR \> 1.7 8- lengthy surgery more than 3 hours . 9- hypersensitivity to local anesthetics. 10- patients with psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (1)

  • Ho B, De Paoli M. Use of Ultrasound-Guided Superficial Cervical Plexus Block for Pain Management in the Emergency Department. J Emerg Med. 2018 Jul;55(1):87-95. doi: 10.1016/j.jemermed.2018.04.030. Epub 2018 May 29.

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia , intensive care and pain management

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start

April 1, 2025

Primary Completion

November 20, 2025

Study Completion

December 1, 2025

Last Updated

November 21, 2025

Record last verified: 2025-11

Locations