Superficial Cervical Plexus Versus Retrolaminar Block in Parotid Surgeries

NCT04138147 | Unknown

• 1 other identifier: MD/19.03.162
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The parotid gland receives sensory and autonomic innervation. Sensory innervation is supplied by the auriculotemporal nerve (gland) and the great auricular nerve (fascia). The parasympathetic innervation to the parotid gland begins with the glossopharyngeal nerve. This nerve synapses with the otic ganglion. The auriculotemporal nerve then carries parasympathetic fibers from the otic ganglion to the parotid gland. Parasympathetic stimulation increase saliva production. Sympathetic innervation from the superior cervical ganglion, part of the paravertebral chain

Conditions

Supportive Care

Keywords

Cervical plexus,; Retrolaminar,; Auriculotemporal,; Parotid

Outcome Measures

Primary Outcomes (1)

• The time of first analgesic request post-operative.

  The time of first analgesic request in hours.

  24 hours postoperative.

Secondary Outcomes (12)

• Total post-operative opioid requirement.

  24 hours postoperative.

• The number of patients required rescue post-operative opioid analgesia..

  24 hours postoperative.

• Post-operative pain scale.

  24 hours postoperative.

• Intra-operative fentanyl consumption.

  Intraoperative (2 hours).

• Heart rate (HR).

  Intraoperative (2 hours), postoperative for 24 hours.

Study Arms (2)

Superficial cervical plexus with auriculotemporal nerve blocks

ACTIVE COMPARATOR

Procedure: Superficial cervical plexus with auriculotemporal nerve blocks

Cervical retrolaminar with auriculotemporal nerve blocks

EXPERIMENTAL

Procedure: Cervical retrolaminar with auriculotemporal nerve blocks

Interventions

Superficial cervical plexus with auriculotemporal nerve blocks PROCEDURE

Superficial cervical plexus block using 10 ml bupivacaine 0.5%. Auriculotemporal nerve block using 3 ml bupivacaine 0.5%.

Superficial cervical plexus with auriculotemporal nerve blocks

Cervical retrolaminar with auriculotemporal nerve blocks PROCEDURE

Cervical retrolaminar block using 10 ml bupivacaine 0.5%. Auriculotemporal nerve block using 3 ml bupivacaine 0.5%.

Cervical retrolaminar with auriculotemporal nerve blocks

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status grade I and grade II.
• Elective parotid surgery.

You may not qualify if:

• Patient refusal.
• Coagulopathy.
• Psychiatric diseases.
• Local skin infection and sepsis at site of the block.
• Known intolerance to the study drugs.
• Body Mass Index \> 40 Kg/m2.
• Central or peripheral neurological disease.
• Previous neck surgery.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Oncology Center, Mansoura University (OCMU)

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

Study Officials

• Alaa M Mazy

  Oncology Center, Mansoura University, Egypt.

  STUDY DIRECTOR

Central Study Contacts

Ghada S Mohammed, Master

CONTACT

00201090085600; dr_adamghada@yahoo.com

Alaa M Mazy, MD

CONTACT

+201140065052; alaa_mazy@yahoo.com

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: SPONSOR

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 24, 2019
• Study Start: November 20, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2 years.

Locations

EG (1)