Supportive CareNCT04138147
Superficial Cervical Plexus Versus Retrolaminar Block in Parotid Surgeries
A study testing Superficial cervical plexus with auriculotemporal nerve blocks and Cervical retrolaminar with auriculotemporal nerve blocks in people with Supportive Care, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Supportive Care
- What is being tested?
- Superficial cervical plexus with auriculotemporal nerve blocks and Cervical retrolaminar with auriculotemporal nerve blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status grade I and grade II.
- Elective parotid surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Oncology Center, Mansoura University (OCMU)
Al Mansurah, Dakahlia Governorate, 35516
Alaa Mazy, MD, 01140065052, alaa_mazy@yahoo.com
Ghada M Mohammed, Master
About this study
Official title: Efficacy of Superficial Cervical Plexus Block Versus Cervical Retrolaminar Block Both Combined With Auriculotemporal Nerve Block in Parotid Surgeries
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
Read the detailed description
Detailed Description:
The aim of this study will be comparing efficacy of superficial cervical plexus block with cervical retro laminar block both combined with auriculotemporal nerve block in parotid surgeries.
Technique of ultrasound guided auriculotemporal nerve block:
The patient will be placed in a supine position with each side facing up. The temporomandibular joint will be identified after palpitation. A high frequency linear ultrasound transducer (7-12 megahertz) will be attached to ultrasound machine (SIEMENS ACUSON P300, Germany) will be placed between the tragus and temporomandibular joint. Color Doppler imaging will be used to identify the superficial temporal artery. The injection needle will be inserted anterior to the tragus posterior to the temporal artery (out-of-plane approach) 1 to 1.5 cm till reaching the periosteum. The reason of out-of-plane approach is that the superficial temporal artery is in the needle entry of in-plane procedure during auriculo-temporal nerve block. Following negative aspiration local anesthetic will be injected in fractionated doses following intermittent aspiration.
Technique of ultrasound guided superficial cervical plexus block:
Standard precautions for the ultrasound guided nerve blocks performance will be done which include standard monitoring, the skin overlying the injection site will be free of signs of infection and after proper skin sterilization with an antiseptic solution and the probe surface in contact with the skin will be covered with a sterile adhesive dressing Patients will be in the supine position with the head turned slightly away from the side to be blocked to facilitate operator access. The anesthesiologist will be at the patient's side at the level of the shoulder. Posterior in-plane approach to the superficial cervical plexus block will be done. In this approach, a high-frequency linear transducer (7-12 Megahertz) will be attached to ultrasound machine (SIEMENS ACUSON P300), the transducer will be placed in a transverse orientation across the neck with the probe marker facing medial (toward the thyroid cartilage). A 22-gauge needle will then be inserted at the posterior border of the sternocleidomastoid muscle at the level of the cricoid cartilage and advanced underneath the muscle belly toward the carotid artery. The needle tip will be positioned to inject local anesthetic deep to the sternocleidomastoid muscle along its tapering posterolateral border but superficial to the prevertebral fascia. Deeper injection should be avoided because it can result in a deep cervical plexus block. As much as 10 ml of local anesthetic will be used for this block.
Technique of ultrasound guided cervical retrolaminar block:
The patients will be in the lateral position. Patient neck will be slightly flexed forward, the anesthesiologist will stand behind the patient. Firstly, landmark will be the identification of cervical vertebrae number 7 as it is the largest and most prominent spinous process by palpation in axial plane. Then the high-frequency linear transducer (7-12 Megahertz) which attach to ultrasound machine (SIEMENS ACUSON P300), Ultrasound scanning will be performed while the probe in transverse position in the mid sagittal plane of cervical vertebrae number 7 spinous process. Then counting up the spinous processes till reaching the spinous process of cervical vertebrae number 4 and then the probe will be moved laterally 1 cm to image the left or right muscles. Identification of the echogenic (bright, reflective) laminae will be seen, above it muscles will be imaged. The splenius capitis lies deep to the trapezius and is a broad, flat muscle. The semispinalis capitis will be easily recognized as a long, strap-like muscle divided into 2 sections by an aponeurotic intersection. The deep neck muscle group has a distinctive tear drop shape (semispinalis cervicis, multifidus, and rotatores).
An in-plane approach by using a 22 gauge, 50 mm, echogenic needle. The needle will be introduced to reach the lamina. After negative aspiration the local anesthetic will be injected through the needle under real-time ultrasound visualization. The criteria for assessment of correct spread of the injectate will creating a plane/hypo-echoic.
- Conditions
- Supportive Care
- Being tested
- Superficial cervical plexus with auriculotemporal nerve blocks, Cervical retrolaminar with auriculotemporal nerve blocks
- Keywords
- Cervical plexus,, Retrolaminar,, Auriculotemporal,, Parotid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial cervical plexus with auriculotemporal nerve blocksProcedure or surgery
Superficial cervical plexus block using 10 ml bupivacaine 0.5%. Auriculotemporal nerve block using 3 ml bupivacaine 0.5%.
Cervical retrolaminar with auriculotemporal nerve blocksProcedure or surgery
Cervical retrolaminar block using 10 ml bupivacaine 0.5%. Auriculotemporal nerve block using 3 ml bupivacaine 0.5%.
| Study group | Role | What they receive |
|---|---|---|
| Superficial cervical plexus with auriculotemporal nerve blocks | Active comparator | Not described Receives: Procedure: Superficial cervical plexus with auriculotemporal nerve blocks |
| Cervical retrolaminar with auriculotemporal nerve blocks | Experimental | Not described Receives: Procedure: Cervical retrolaminar with auriculotemporal nerve blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of first analgesic request post-operative.
The time of first analgesic request in hours.
Measured: 24 hours postoperative.
Secondary outcomes (12)
Total post-operative opioid requirement.
Total post-operative morphine requirement in milligrams..
Measured: 24 hours postoperative.
The number of patients required rescue post-operative opioid analgesia..
in number.
Measured: 24 hours postoperative.
Post-operative pain scale.
by Visual analogue scale (VAS): (where 0 means no pain- while 100 mm is the worst pain) at 0, 1, 2, 6, 12 and 24 hours.
Measured: 24 hours postoperative.
Intra-operative fentanyl consumption.
in micro grams.
Measured: Intraoperative (2 hours).
Heart rate (HR).
in beat/minutes, recorded basal, intraoperative: after the block 15 min and 30 min then every 30 minutes till the end of surgery, then postoperative at 0, 1, 2, 6, 12 and 24 hours.
Measured: Intraoperative (2 hours), postoperative for 24 hours.
Mean arterial blood pressure (MAP).
Non invasive mean arterial pressure, in mmHg, recorded intraoperative: basal, after the block at 15 min and 30 min then every 30 minutes till the end of surgery, then postoperative at 0, 1, 2, 6, 12 and 24 hours.
Measured: Intraoperative (2 hours), postoperative for 24 hours.
Intra-operative atracurium consumption
in milligrams.
Measured: Intraoperative (2 hours).
The concentration of isoflurane.
in percent, recorded after the block every 30 minutes till the end of surgery.
Measured: Intraoperative (2 hours).
Sensory block assessment.
Define the number of blocked dermatomes at post anesthesia care unit by skin pinprick. sensation at dermatomal distribution.
Measured: 1 hour post-operative.
The block procedural duration.
In minutes.
Measured: 30 minutes.
Post-operative complication rate (nausea, vomiting and headache)
In number.
Measured: 24 hours postoperative.
Assessment of diaphragmatic dysfunction.
Using ultrasound assessment,
Measured: 1 hour postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start20 Nov 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supportive CareStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alaa M Mazy, Study director, Oncology Center, Mansoura University, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138147
- Sponsor's protocol ID
- MD/19.03.162
- Status last verified
- Sep 2020
- First submitted
- 21 Oct 2019
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after publication.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Superficial Cervical Plexus Block Versus Cervical Retrolaminar Block Both Combined With Auriculotemporal Nerve Block in Parotid Surgeries
- ClinicalTrials.gov ID
- NCT04138147
- Acronym / sponsor ID
- MD/19.03.162
- Conditions
- Supportive Care
- Keywords
- Cervical plexus,, Retrolaminar,, Auriculotemporal,, Parotid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Detailed Description:
The aim of this study will be comparing efficacy of superficial cervical plexus block with cervical retro laminar block both combined with auriculotemporal nerve block in parotid surgeries.
Technique of ultrasound guided auriculotemporal nerve block:
The patient will be placed in a supine position with each side facing up. The temporomandibular joint will be identified after palpitation. A high frequency linear ultrasound transducer (7-12 megahertz) will be attached to ultrasound machine (SIEMENS ACUSON P300, Germany) will be placed between the tragus and temporomandibular joint. Color Doppler imaging will be used to identify the superficial temporal artery. The injection needle will be inserted anterior to the tragus posterior to the temporal artery (out-of-plane approach) 1 to 1.5 cm till reaching the periosteum. The reason of out-of-plane approach is that the superficial temporal artery is in the needle entry of in-plane procedure during auriculo-temporal nerve block. Following negative aspiration local anesthetic will be injected in fractionated doses following intermittent aspiration.
Technique of ultrasound guided superficial cervical plexus block:
Standard precautions for the ultrasound guided nerve blocks performance will be done which include standard monitoring, the skin overlying the injection site will be free of signs of infection and after proper skin sterilization with an antiseptic solution and the probe surface in contact with the skin will be covered with a sterile adhesive dressing Patients will be in the supine position with the head turned slightly away from the side to be blocked to facilitate operator access. The anesthesiologist will be at the patient's side at the level of the shoulder. Posterior in-plane approach to the superficial cervical plexus block will be done. In this approach, a high-frequency linear transducer (7-12 Megahertz) will be attached to ultrasound machine (SIEMENS ACUSON P300), the transducer will be placed in a transverse orientation across the neck with the probe marker facing medial (toward the thyroid cartilage). A 22-gauge needle will then be inserted at the posterior border of the sternocleidomastoid muscle at the level of the cricoid cartilage and advanced underneath the muscle belly toward the carotid artery. The needle tip will be positioned to inject local anesthetic deep to the sternocleidomastoid muscle along its tapering posterolateral border but superficial to the prevertebral fascia. Deeper injection should be avoided because it can result in a deep cervical plexus block. As much as 10 ml of local anesthetic will be used for this block.
Technique of ultrasound guided cervical retrolaminar block:
The patients will be in the lateral position. Patient neck will be slightly flexed forward, the anesthesiologist will stand behind the patient. Firstly, landmark will be the identification of cervical vertebrae number 7 as it is the largest and most prominent spinous process by palpation in axial plane. Then the high-frequency linear transducer (7-12 Megahertz) which attach to ultrasound machine (SIEMENS ACUSON P300), Ultrasound scanning will be performed while the probe in transverse position in the mid sagittal plane of cervical vertebrae number 7 spinous process. Then counting up the spinous processes till reaching the spinous process of cervical vertebrae number 4 and then the probe will be moved laterally 1 cm to image the left or right muscles. Identification of the echogenic (bright, reflective) laminae will be seen, above it muscles will be imaged. The splenius capitis lies deep to the trapezius and is a broad, flat muscle. The semispinalis capitis will be easily recognized as a long, strap-like muscle divided into 2 sections by an aponeurotic intersection. The deep neck muscle group has a distinctive tear drop shape (semispinalis cervicis, multifidus, and rotatores).
An in-plane approach by using a 22 gauge, 50 mm, echogenic needle. The needle will be introduced to reach the lamina. After negative aspiration the local anesthetic will be injected through the needle under real-time ultrasound visualization. The criteria for assessment of correct spread of the injectate will creating a plane/hypo-echoic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status grade I and grade II.
- Elective parotid surgery.
Key exclusion criteria (8 listed)
- Patient refusal.
- Coagulopathy.
- Psychiatric diseases.
- Local skin infection and sepsis at site of the block.
- Known intolerance to the study drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superficial cervical plexus with auriculotemporal nerve blocksSuperficial cervical plexus block using 10 ml bupivacaine 0.5%. Auriculotemporal nerve block using 3 ml bupivacaine 0.5%. | Procedure or surgery | Superficial cervical plexus with auriculotemporal nerve blocks |
| Cervical retrolaminar with auriculotemporal nerve blocksCervical retrolaminar block using 10 ml bupivacaine 0.5%. Auriculotemporal nerve block using 3 ml bupivacaine 0.5%. | Procedure or surgery | Cervical retrolaminar with auriculotemporal nerve blocks |
Primary outcome
The time of first analgesic request post-operative.
Time frame: 24 hours postoperative.
The time of first analgesic request in hours.
12 secondary outcomes
Total post-operative opioid requirement.
Time frame: 24 hours postoperative.
The number of patients required rescue post-operative opioid analgesia..
Time frame: 24 hours postoperative.
Post-operative pain scale.
Time frame: 24 hours postoperative.
Intra-operative fentanyl consumption.
Time frame: Intraoperative (2 hours).
Heart rate (HR).
Time frame: Intraoperative (2 hours), postoperative for 24 hours.
Mean arterial blood pressure (MAP).
Time frame: Intraoperative (2 hours), postoperative for 24 hours.
Intra-operative atracurium consumption
Time frame: Intraoperative (2 hours).
The concentration of isoflurane.
Time frame: Intraoperative (2 hours).
Sensory block assessment.
Time frame: 1 hour post-operative.
The block procedural duration.
Time frame: 30 minutes.
Post-operative complication rate (nausea, vomiting and headache)
Time frame: 24 hours postoperative.
Assessment of diaphragmatic dysfunction.
Time frame: 1 hour postoperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Individual participant dataSharing planned: Yes. after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa M Mazy study director
Oncology Center, Mansoura University, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superficial cervical plexus with auriculotemporal nerve blocks and Cervical retrolaminar with auriculotemporal nerve blocks in people with Supportive Care, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghada S Mohammed, Master (00201090085600, dr_adamghada@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of first analgesic request post-operative. (time frame: 24 hours postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.