Thyroid SurgeryNCT03269890
The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks
A study testing Capsule and cutaneous blocks and US-intermediate cervical plexus block in people with Thyroid Surgery, run by Mansoura University at 1 site in Egypt.
Trial summary
Thyroid gland surgery is one of the most commonly performed operations for either benign or malignant pathologies Pain related to thyroid surgery is of moderate intensity .which may be treated with NSAIDs or opioids. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Thyroid Surgery
- What is being tested?
- Capsule and cutaneous blocks and US-intermediate cervical plexus block
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 30 Sep 2018
- 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.
- Euthyroidism after thyroid function tests
Who cannot join
- Patient refusal.
- Thyroid gland more than 5 cm size.
- Retrosternal extension.
- Planned block neck dissection.
- Neuromuscular diseases
- Hematological diseases.
Show all 17Show fewer
- Bleeding diseases.
- Coagulation abnormality.
- Psychiatric diseases.
- Drug abuse.
- Local skin infection
- sepsis at site of the block.
- Known intolerance to the study drugs.
- Body Mass Index > 40 Kg/m2.
- Known diaphragmatic motion abnormalities
- major respiratory disease.
- Previous history of cervical surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks in Thyroid Surgeries
Thyroid gland surgery is one of the most commonly performed operations for either benign or malignant pathologies Pain related to thyroid surgery is of moderate intensity .which may be treated with NSAIDs or opioids. However, Opioids have many well-known undesirable effects, including postoperative nausea and vomiting, which are frequent after this type of procedure.
Read the detailed description
Regional techniques of anesthesia may help to decrease post-operative pain and reduce systemic analgesic requirement. Classically, the cervical plexus is considered to have two distributions, the superficial cutaneous and the deep motor nerves.
Anatomically, the thyroid gland has an inner true capsule which is thin and adheres closely to the thyroidal tissue [Fancy et al., 2010]. External to this is a false capsule formed by the middle layer of the deep cervical fascia, which splits anterolaterally to ensheathe the thyroid gland, thus forming the thyroid sheath [Bliss et al., 2000]. In this fashion, the potential space called the capsule-sheath space is formed. It contains also loose connective tissue, blood vessels, nerves and parathyroid gland. Anesthetic deposited in this space would block the surface of thyroid gland and permeate directly into the parenchyma producing effective local anesthesia for thyroid surgical procedures. It is supposed also to involve autonomic nerve block of the thyroid gland [Fliers et al., 2010]. Additionally, a subcutaneous injection along the sternocleidomastoid muscle (SCM) would also enhance effective local anesthesia for the initial skin incision and further contribute to a more ideal working environment for the surgeon. Therefore, anesthetic technique termed ultrasound-guided capsule-sheath space block (CSSB) combined with anterior cervical cutaneous nerves block (CCNB) for thyroidectomy is done [Wang et al., 2015] .
Our hypothesis is that a combination of simple dual techniques including superficial cutaneous block to provide sensory blockade, and surgeon mediated capsular block may afford autonomic thyroid blockade. In comparison, ultrasound guided intermediate cervical plexus block may provide these blocks but using a machine and deep penetration possibly involving unwanted blocks for phrenic and recurrent laryngeal nerves. So, if the simple safe technique can provide the same intra and postoperative anesthetic conditions it will be preferred.
- Conditions
- Thyroid Surgery
- Being tested
- Capsule and cutaneous blocks, US-intermediate cervical plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule and cutaneous blocksProcedure or surgery
7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks once before surgery per side
US-intermediate cervical plexus blockProcedure or surgery
15 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml once before surgery per side.
| Study group | Role | What they receive |
|---|---|---|
| Capsule and cutaneous blocks | Experimental | 7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks per side. once before surgery Receives: Procedure: Capsule and cutaneous blocks |
| US-intermediate cervical plexus block | Active comparator | 15 mL of 0.5% isobaric bupivacaine + Epinephrine 5 microgram/ ml. per side. once before surgery Receives: Procedure: US-intermediate cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of opioid analgesics used
The total dose of opioid analgesics required in the post-operative periods
Measured: For 24 hours after surgery
Secondary outcomes (13)
Postoperative pain
Postoperative visual analogue score (VAS) (0 no pain -10 worst imaginable pain),
Measured: For 24 hours after surgery
Time to first analgesic request
Time to first request for a rescue analgesic
Measured: For 24 hours after surgery
Fentanyl use
Intraoperative use of fentanyl
Measured: For 5 hours after start of anaesthesia
Rocuronium use
Intraoperative use of rocuronium
Measured: For 5 hours after start of anaesthesia
Sensory blockade
Assessment of sensory blockade
Measured: for 1 hour after surgery
Diaphragmatic dysfunction
Diaphragmatic dysfunction using ultrasound assessment and possible x ray
Measured: for 5 hours after performing blockade
Sedation score
Sedation score using Modified Ramsay scale
Measured: for 5 hours after performing blockade
Patient satisfaction
Patient satisfaction regards analgesia using a score of (0-10) with 10 represents the highest satisfaction
Measured: for 24 hrs after surgery
Postoperative nausea and vomiting
frequency
Measured: For 24 hours after surgery
Postoperative headache
frequency
Measured: For 24 hours after surgery
Hoarseness of voice
frequency
Measured: For 24 hours after surgery
Dysphagia
frequency
Measured: For 24 hours after surgery
Respiratory difficulty
Peripheral oxygen saturation less than 92%
Measured: For 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Oct 2017
- Primary completion1 Jun 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid SurgeryStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moneir O El-Hefny, MD, Study chair, Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269890
- Sponsor's protocol ID
- MS/17.03.138
- Status last verified
- Sep 2020
- First submitted
- 29 Aug 2017
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks in Thyroid Surgeries
- ClinicalTrials.gov ID
- NCT03269890
- Acronym / sponsor ID
- MS/17.03.138
- Conditions
- Thyroid Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 1 Sep 2017 (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.
Thyroid gland surgery is one of the most commonly performed operations for either benign or malignant pathologies Pain related to thyroid surgery is of moderate intensity .which may be treated with NSAIDs or opioids. However, Opioids have many well-known undesirable effects, including postoperative nausea and vomiting, which are frequent after this type of procedure.
Detailed description
Regional techniques of anesthesia may help to decrease post-operative pain and reduce systemic analgesic requirement. Classically, the cervical plexus is considered to have two distributions, the superficial cutaneous and the deep motor nerves.
Anatomically, the thyroid gland has an inner true capsule which is thin and adheres closely to the thyroidal tissue [Fancy et al., 2010]. External to this is a false capsule formed by the middle layer of the deep cervical fascia, which splits anterolaterally to ensheathe the thyroid gland, thus forming the thyroid sheath [Bliss et al., 2000]. In this fashion, the potential space called the capsule-sheath space is formed. It contains also loose connective tissue, blood vessels, nerves and parathyroid gland. Anesthetic deposited in this space would block the surface of thyroid gland and permeate directly into the parenchyma producing effective local anesthesia for thyroid surgical procedures. It is supposed also to involve autonomic nerve block of the thyroid gland [Fliers et al., 2010]. Additionally, a subcutaneous injection along the sternocleidomastoid muscle (SCM) would also enhance effective local anesthesia for the initial skin incision and further contribute to a more ideal working environment for the surgeon. Therefore, anesthetic technique termed ultrasound-guided capsule-sheath space block (CSSB) combined with anterior cervical cutaneous nerves block (CCNB) for thyroidectomy is done [Wang et al., 2015] .
Our hypothesis is that a combination of simple dual techniques including superficial cutaneous block to provide sensory blockade, and surgeon mediated capsular block may afford autonomic thyroid blockade. In comparison, ultrasound guided intermediate cervical plexus block may provide these blocks but using a machine and deep penetration possibly involving unwanted blocks for phrenic and recurrent laryngeal nerves. So, if the simple safe technique can provide the same intra and postoperative anesthetic conditions it will be preferred.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsule and cutaneous blocks | Experimental | Procedure: Capsule and cutaneous blocks7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks per side. once before surgery |
| US-intermediate cervical plexus block | Active comparator | Procedure: US-intermediate cervical plexus block15 mL of 0.5% isobaric bupivacaine + Epinephrine 5 microgram/ ml. per side. once before surgery |
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.
- Euthyroidism after thyroid function tests
Key exclusion criteria (17 listed)
- Patient refusal.
- Thyroid gland more than 5 cm size.
- Retrosternal extension.
- Planned block neck dissection.
- Neuromuscular diseases
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 |
|---|---|---|
| Capsule and cutaneous blocks7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks once before surgery per side | Procedure or surgery | Capsule and cutaneous blocks |
| US-intermediate cervical plexus block15 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml once before surgery per side. | Procedure or surgery | US-intermediate cervical plexus block |
Primary outcome
Total dose of opioid analgesics used
Time frame: For 24 hours after surgery
The total dose of opioid analgesics required in the post-operative periods
13 secondary outcomes
Postoperative pain
Time frame: For 24 hours after surgery
Time to first analgesic request
Time frame: For 24 hours after surgery
Fentanyl use
Time frame: For 5 hours after start of anaesthesia
Rocuronium use
Time frame: For 5 hours after start of anaesthesia
Sensory blockade
Time frame: for 1 hour after surgery
Diaphragmatic dysfunction
Time frame: for 5 hours after performing blockade
Sedation score
Time frame: for 5 hours after performing blockade
Patient satisfaction
Time frame: for 24 hrs after surgery
Postoperative nausea and vomiting
Time frame: For 24 hours after surgery
Postoperative headache
Time frame: For 24 hours after surgery
Hoarseness of voice
Time frame: For 24 hours after surgery
Dysphagia
Time frame: For 24 hours after surgery
Respiratory difficulty
Time frame: For 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Thyroid Surgery
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
Enrolling by invitation
Effect of Cold Water Spray on Swallowing Difficulty, Pain, and Thirst After Thyroid Surgery
Swallowing Difficulties, Thirst
Recruiting
Intramuscular Injection of Mashed Parathyroid Tissue Into a Forearm During Thyroid Surgery to Prevent Permanent Postoperative Parathyroid Insufficiency (IMIPAT Study)
Graft Function
Active, not recruitingPhase 2
Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer
Thyroid Gland Anaplastic Carcinoma, Thyroid Gland Squamous Cell Carcinoma
Recruiting
Opioid-Free Versus Opioid-Based Anesthesia in Thyroid Surgery
Thyroidectomy, Oxidative Stress
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.
Moneir O El-Hefny, MD study chair
Professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsule and cutaneous blocks and US-intermediate cervical plexus block in people with Thyroid Surgery, 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 17 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: finished, as of the sponsor's last update on 22 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total dose of opioid analgesics used (time frame: For 24 hours after surgery). 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 22 Sep 2020.