CervicalNCT06974630
Cervical Erector Spinae Plane Block vs Cervical Plexus Block in Controlling Acute Postoperative Pain After Thyroidectomy
A study testing Cervical erector spinae plane block and Cervical plexus block in people with Cervical and Erector Spinae Plane Block, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy and safety of cervical erector spinae plane block vs. cervical plexus block in controlling acute postoperative pain after thyroidectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical, Erector Spinae Plane Block, Cervical Plexus Block
- What is being tested?
- Cervical erector spinae plane block and Cervical plexus block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2025to 30 Nov 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both genders.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Scheduled for either hemi- or total thyroidectomy.
Who cannot join
- Known allergy to local anesthetics.
- Allergy to all opioid medications.
- Pregnant patient.
- Previous neck surgery.
- Recent use of non-steroidal anti-inflammatory drugs (NSAIDs), opioids or steroid injection within 2 weeks.
- Those who cannot utilize the numeric rating scale (NRS) .
- Chronic opioid use.
- Coagulopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cervical Erector Spinae Plane Block vs Cervical Plexus Block in Controlling Acute Postoperative Pain After Thyroidectomy: A Randomized Controlled Study
This study aims to compare the efficacy and safety of cervical erector spinae plane block vs. cervical plexus block in controlling acute postoperative pain after thyroidectomy.
Read the detailed description
Thyroidectomy is one of the most commonly performed surgeries in females worldwide, as thyroid disease predominantly affects females with a ratio of 4:1. Thyroid operations can cause mild to moderate incisional pain. It has also been reported that the morphine consumption on the first postoperative day is 90%.
Cervical plexus block, either superficial or deep or combinations given bilaterally, could easily lead to an adequate block appropriate for thyroid surgery without any significant side effects.
Erector spinae plane block (ESPB) is the new favorite among various fascial plane blocks. Local anesthetic drug is injected in the fascial plane superficial to the transverse process and deeper to the erector spinae muscle (ESM).
- Conditions
- Cervical, Erector Spinae Plane Block, Cervical Plexus Block, Postoperative Pain, Thyroidectomy
- Being tested
- Cervical erector spinae plane block, Cervical plexus block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical erector spinae plane blockOther
Also called Bupivacaine 0.25%
Patients will receive bilateral ultrasound-guided cervical erector spinae plane block using 15 ml of bupivacaine 0.25% on each side.
Cervical plexus blockOther
Also called Bupivacaine 0.25%
Patients will receive bilateral ultrasound-guided superficial cervical block using 15 mL of 0.25% plain bupivacaine on each side of the neck.
| Study group | Role | What they receive |
|---|---|---|
| ESPB group | Experimental | Patients will receive bilateral ultrasound-guided cervical erector spinae plane block using 15 ml of bupivacaine 0.25% on each side. Receives: Other: Cervical erector spinae plane block |
| SCPB group | Active comparator | Patients will receive bilateral ultrasound-guided superficial cervical block using 15 mL of 0.25% plain bupivacaine on each side of the neck. Receives: Other: Cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4.
Measured: 48 hours postoperatively
Secondary outcomes (4)
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).
Measured: 48 hours postoperatively
Intraoperative fentanyl consumption
Additional bolus doses of fentanyl 1 µg/kg will be given if the mean arterial blood pressure (MAP) or heart rate (HR) rises above 20% of baseline levels.
Measured: Intraoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at post-anesthesia care unit (PACU), 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48 h postoperative.
Measured: 48 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as nausea, vomiting, hypotension, bradycardia, cough, bronchospasm, and sore throat will be recorded.
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start15 May 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CervicalStudies of the same condition, open and under way.
- More trials run by Cairo 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsaid Abdel Fattah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974630
- Sponsor's protocol ID
- AP2411-501-102-193
- Status last verified
- Dec 2025
- First submitted
- 8 May 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Erector Spinae Plane Block vs Cervical Plexus Block in Controlling Acute Postoperative Pain After Thyroidectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06974630
- Acronym / sponsor ID
- AP2411-501-102-193
- Conditions
- Cervical, Erector Spinae Plane Block, Cervical Plexus Block, Postoperative Pain, Thyroidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 16 May 2025 (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.
This study aims to compare the efficacy and safety of cervical erector spinae plane block vs. cervical plexus block in controlling acute postoperative pain after thyroidectomy.
Detailed description
Thyroidectomy is one of the most commonly performed surgeries in females worldwide, as thyroid disease predominantly affects females with a ratio of 4:1. Thyroid operations can cause mild to moderate incisional pain. It has also been reported that the morphine consumption on the first postoperative day is 90%.
Cervical plexus block, either superficial or deep or combinations given bilaterally, could easily lead to an adequate block appropriate for thyroid surgery without any significant side effects.
Erector spinae plane block (ESPB) is the new favorite among various fascial plane blocks. Local anesthetic drug is injected in the fascial plane superficial to the transverse process and deeper to the erector spinae muscle (ESM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB group | Experimental | Other: Cervical erector spinae plane blockPatients will receive bilateral ultrasound-guided cervical erector spinae plane block using 15 ml of bupivacaine 0.25% on each side. |
| SCPB group | Active comparator | Other: Cervical plexus blockPatients will receive bilateral ultrasound-guided superficial cervical block using 15 mL of 0.25% plain bupivacaine on each side of the neck. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 65 years.
- Both genders.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Scheduled for either hemi- or total thyroidectomy.
Key exclusion criteria (8 listed)
- Known allergy to local anesthetics.
- Allergy to all opioid medications.
- Pregnant patient.
- Previous neck surgery.
- Recent use of non-steroidal anti-inflammatory drugs (NSAIDs), opioids or steroid injection within 2 weeks.
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 |
|---|---|---|
| Cervical erector spinae plane blockAlso: Bupivacaine 0.25%Patients will receive bilateral ultrasound-guided cervical erector spinae plane block using 15 ml of bupivacaine 0.25% on each side. | Other | ESPB group |
| Cervical plexus blockAlso: Bupivacaine 0.25%Patients will receive bilateral ultrasound-guided superficial cervical block using 15 mL of 0.25% plain bupivacaine on each side of the neck. | Other | SCPB group |
Primary outcome
Total morphine consumption
Time frame: 48 hours postoperatively
Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4.
4 secondary outcomes
Time to the 1st rescue analgesia
Time frame: 48 hours postoperatively
Intraoperative fentanyl consumption
Time frame: Intraoperatively
Degree of pain
Time frame: 48 hours postoperatively
Incidence of adverse events
Time frame: 48 hours postoperatively
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 29 Dec 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical erector spinae plane block and Cervical plexus block in people with Cervical and Erector Spinae Plane Block, run by Cairo 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 4 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: finished, as of the sponsor's last update on 29 Dec 2025. 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 morphine consumption (time frame: 48 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 29 Dec 2025.