Bilateral Ultrasound Guided Superficial Cervical Plexus BlockNCT05476003
Bilateral Ultrasound Guided Superficial Cervical Plexus Block After Thyroid Surgery
A study testing Ultrasound-guided Bilateral superficial cervical plexus block and Midazolam in people with Bilateral Ultrasound Guided Superficial Cervical Plexus Block and Thyroid Surgery, run by Tanta University.
Trial summary
Evaluating ultrasound guided Bilateral Superficial Cervical Plexus Block as a part of enhanced recovery after thyroid surgery using Quality of Recovery-15 scale as a method for assessment of quality of recovery. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Bilateral Ultrasound Guided Superficial Cervical Plexus Block, Thyroid Surgery, Enhanced Recovery
- What is being tested?
- Ultrasound-guided Bilateral superficial cervical plexus block and Midazolam
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2022to 15 Sep 2023
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 21 to 65 years
- American Society of Anesthesiologists physical status I or II.
- Scheduled for elective thyroid surgery.
Who cannot join
- Patient refusal to participate.
- Patients with history of allergy to local anesthetics.
- Patients with history of chronic use of pain killers .
- Patients presented with mental dysfunction.
- Patients with coagulation disorders.
- Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
- Patients with Chronic Obstructive Pulmonary Disease or Body Mass Index more than 40.
About this study
Official title: Role of Bilateral Ultrasound Guided Superficial Cervical Plexus Block as a Part of Enhanced Recovery After Thyroid Surgery
Evaluating ultrasound guided Bilateral Superficial Cervical Plexus Block as a part of enhanced recovery after thyroid surgery using Quality of Recovery-15 scale as a method for assessment of quality of recovery.
Read the detailed description
Surgery of the thyroid gland is increasingly popular performed as ambulatory procedures in many countries. Postoperative wound pain is a common complication, especially within 24 hr after thyroid surgery, which may delay discharge or even unplanned readmissions following day surgery.
Several strategies, including local and regional anesthesia, are now performed as core components of multimodal analgesia for postoperative pain. Adequate postoperative pain relief is imperative to improve functional outcome, accelerate early ambulation and discharge from the hospital.
Ultrasound-guided superficial cervical plexus block was introduced by Tran et al . The main advantages of Ultrasound-guided superficial cervical plexus block include: provide real-time visualization of anatomical structures, reduced volumes of local anesthetics, and avoid inadvertent damage or accidental puncture of vessels.
Owing to its feasibility and efficacy, ultrasound-guided Bilateral superficial cervical plexus block is a technique for providing adequate regional analgesia during thyroidectomy with improvement of patient recovery.
Quality of recovery after anesthesia is an important measure of the early postoperative health status of patients. Based on extensive clinical and research experience with the 40-item Quality of Recovery-40, the strongest psychometrically performing items from each of the five dimensions of the Quality of Recovery-40 were selected to create a short-form version. The Quality of Recovery-15 provides a valid, extensive, and yet efficient evaluation of postoperative Quality of Recovery.
- Conditions
- Bilateral Ultrasound Guided Superficial Cervical Plexus Block, Thyroid Surgery, Enhanced Recovery
- Being tested
- Ultrasound-guided Bilateral superficial cervical plexus block, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Bilateral superficial cervical plexus blockProcedure or surgery
This nerve block is typically performed in the supine or semi-sitting position, with the head turned slightly away from the side to be blocked to facilitate operator access.
Under strict aseptic condition, the linear ultrasound transducer should be placed on the lateral neck, overlying the sternocleidomastoid muscle at the level of its midpoint (approximately the level of the cricoid cartilage). Once the sternocleidomastoid muscle has been identified, the transducer is moved posteriorly until the tapering posterior edge is positioned in the middle of the screen.
Once the plexus has been identified and using In-Plane approach, the needle is passed from medial to lateral through the skin, platysma and investing layer of deep cervical fascia and the tip is placed adjacent to the plexus.
Following negative aspiration, 1 mL of local anesthetic is injected to confirm the proper injection site. The remainder of the local anesthetic (5ml) is administered to envelop the plexus.
MidazolamDrug
All patients will be premedicated with Midazolam (0.02mg/Kg).
| Study group | Role | What they receive |
|---|---|---|
| Sham Technique | Sham comparator | Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of 10 ml normal saline bilaterally. Receives: Procedure: Ultrasound-guided Bilateral superficial cervical plexus block; Drug: Midazolam |
| Ultrasound-guided Bilateral superficial cervical plexus block | Active comparator | Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of total volume 10 ml containing Bupivacaine 0.25% (5 ml Bupivacaine 0.5 % and 5 ml normal saline). Receives: Procedure: Ultrasound-guided Bilateral superficial cervical plexus block; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery
Improvement of the quality of recovery assessed using the 15-item quality of recovery questionnaire. The Quality of Recovery-15 included 15 items 1-Breathing 2-Food 3-Rest 4-Sleep 5-Hygiene 6-Communication 7-Support 8-Return to work 9-Feeling comfortable and in control 10-Feeling of general well-being 10-Moderate pain 12-Severe pain 13-Nausea/Vomitting 14-Worry/Anxiety 15-Feeling sad or depressed .
Each item will be assessed using a10-point numerical rating scale. The total score of Quality of Recovery-15 ranges from 0 (extremely poor recovery) to 150 (all excellent recovery).
Measured: 24 hours postoperatively.
Secondary outcomes (3)
Postoperative analgesia
Postoperative analgesia defined by the visual analogue scale score 30 min after arrival to recovery room then after 2, 4, 6, 12, 24 hr. If visual analogue scale˃ 3 , morphine 3 mg will be given .
Measured: 24 hours postoperatively
Opioid consumption
Total post operative opioid requirement will be recorded
Measured: 24 hours postoperatively
Diaphragmatic Excursion
Diaphragmatic Excursion assessed by Ultrasound
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start15 Aug 2022 (estimated)
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Ultrasound Guided Superficial Cervical Plexus BlockStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Elsamahy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476003
- Sponsor's protocol ID
- 34751/6/21
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Bilateral Ultrasound Guided Superficial Cervical Plexus Block as a Part of Enhanced Recovery After Thyroid Surgery
- ClinicalTrials.gov ID
- NCT05476003
- Acronym / sponsor ID
- 34751/6/21
- Conditions
- Bilateral Ultrasound Guided Superficial Cervical Plexus Block, Thyroid Surgery, Enhanced Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (estimated)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 27 Jul 2022 (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.
Evaluating ultrasound guided Bilateral Superficial Cervical Plexus Block as a part of enhanced recovery after thyroid surgery using Quality of Recovery-15 scale as a method for assessment of quality of recovery.
Detailed description
Surgery of the thyroid gland is increasingly popular performed as ambulatory procedures in many countries. Postoperative wound pain is a common complication, especially within 24 hr after thyroid surgery, which may delay discharge or even unplanned readmissions following day surgery.
Several strategies, including local and regional anesthesia, are now performed as core components of multimodal analgesia for postoperative pain. Adequate postoperative pain relief is imperative to improve functional outcome, accelerate early ambulation and discharge from the hospital.
Ultrasound-guided superficial cervical plexus block was introduced by Tran et al . The main advantages of Ultrasound-guided superficial cervical plexus block include: provide real-time visualization of anatomical structures, reduced volumes of local anesthetics, and avoid inadvertent damage or accidental puncture of vessels.
Owing to its feasibility and efficacy, ultrasound-guided Bilateral superficial cervical plexus block is a technique for providing adequate regional analgesia during thyroidectomy with improvement of patient recovery.
Quality of recovery after anesthesia is an important measure of the early postoperative health status of patients. Based on extensive clinical and research experience with the 40-item Quality of Recovery-40, the strongest psychometrically performing items from each of the five dimensions of the Quality of Recovery-40 were selected to create a short-form version. The Quality of Recovery-15 provides a valid, extensive, and yet efficient evaluation of postoperative Quality of Recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Technique | Sham comparator | Procedure: Ultrasound-guided Bilateral superficial cervical plexus block, Drug: MidazolamPatients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of 10 ml normal saline bilaterally. |
| Ultrasound-guided Bilateral superficial cervical plexus block | Active comparator | Procedure: Ultrasound-guided Bilateral superficial cervical plexus block, Drug: MidazolamPatients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of total volume 10 ml containing Bupivacaine 0.25% (5 ml Bupivacaine 0.5 % and 5 ml normal saline). |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 21 to 65 years
- American Society of Anesthesiologists physical status I or II.
- Scheduled for elective thyroid surgery.
Key exclusion criteria (7 listed)
- Patient refusal to participate.
- Patients with history of allergy to local anesthetics.
- Patients with history of chronic use of pain killers .
- Patients presented with mental dysfunction.
- Patients with coagulation disorders.
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 |
|---|---|---|
| Ultrasound-guided Bilateral superficial cervical plexus blockThis nerve block is typically performed in the supine or semi-sitting position, with the head turned slightly away from the side to be blocked to facilitate operator access. Under strict aseptic condition, the linear ultrasound transducer should be placed on the lateral neck, overlying the sternocleidomastoid muscle at the level of its midpoint (approximately the level of the cricoid cartilage). Once the sternocleidomastoid muscle has been identified, the transducer is moved posteriorly until the tapering posterior edge is positioned in the middle of the screen. Once the plexus has been identified and using In-Plane approach, the needle is passed from medial to lateral through the skin, platysma and investing layer of deep cervical fascia and the tip is placed adjacent to the plexus. Following negative aspiration, 1 mL of local anesthetic is injected to confirm the proper injection site. The remainder of the local anesthetic (5ml) is administered to envelop the plexus. | Procedure or surgery | Sham Technique, Ultrasound-guided Bilateral superficial cervical plexus block |
| MidazolamAll patients will be premedicated with Midazolam (0.02mg/Kg). | Drug | Sham Technique, Ultrasound-guided Bilateral superficial cervical plexus block |
Primary outcome
Quality of recovery
Time frame: 24 hours postoperatively.
Improvement of the quality of recovery assessed using the 15-item quality of recovery questionnaire. The Quality of Recovery-15 included 15 items 1-Breathing 2-Food 3-Rest 4-Sleep 5-Hygiene 6-Communication 7-Support 8-Return to work 9-Feeling comfortable and in control 10-Feeling of general well-being 10-Moderate pain 12-Severe pain 13-Nausea/Vomitting 14-Worry/Anxiety 15-Feeling sad or depressed . Each item will be assessed using a10-point numerical rating scale. The total score of Quality of Recovery-15 ranges from 0 (extremely poor recovery) to 150 (all excellent recovery).
3 secondary outcomes
Postoperative analgesia
Time frame: 24 hours postoperatively
Opioid consumption
Time frame: 24 hours postoperatively
Diaphragmatic Excursion
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Bilateral superficial cervical plexus block and Midazolam in people with Bilateral Ultrasound Guided Superficial Cervical Plexus Block and Thyroid Surgery, run by Tanta University.
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 3 inclusion and 7 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 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery (time frame: 24 hours postoperatively.). 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 1 Aug 2022.