Postoperative PainNCT07496970
Bilateral Cervical Plexus Block for Postoperative Pain After Thyroidectomy
A study testing Ultrasound-Guided Bilateral Superficial Cervical Plexus Block and Standard general anesthesia in people with Postoperative Pain, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
Patients undergoing thyroidectomy frequently experience moderate postoperative pain that may require opioid analgesics. Opioid use is associated with adverse effects such as nausea, vomiting, respiratory depression, and delayed recovery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ultrasound-Guided Bilateral Superficial Cervical Plexus Block and Standard general anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 15 Jul 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years American Society of Anesthesiologists (ASA) physical status I-III Scheduled for elective surgery under general anesthesia Ability to provide written informed consent
Who cannot join
- Allergy to local anesthetic agents Coagulation disorders or anticoagulant use Infection at the injection site Severe cardiac, respiratory, hepatic, or renal disease Pregnancy or breastfeeding Inability to understand pain scoring systems (VAS/NRS)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Postoperative Analgesic Effect of Ultrasound-Guided Bilateral Superficial Cervical Plexus Block in Patients Undergoing Thyroidectomy Under General Anesthesia: A Prospective Randomized Controlled Study
Patients undergoing thyroidectomy frequently experience moderate postoperative pain that may require opioid analgesics. Opioid use is associated with adverse effects such as nausea, vomiting, respiratory depression, and delayed recovery. Ultrasound-guided regional anesthesia techniques may provide effective postoperative analgesia while reducing opioid consumption.
The aim of this prospective randomized study was to evaluate the analgesic efficacy of ultrasound-guided bilateral superficial cervical plexus block (BSCPB) in patients undergoing thyroidectomy under general anesthesia. Patients were divided into two groups: a block group receiving BSCPB with 0.5% bupivacaine and a control group receiving general anesthesia alone. Postoperative pain scores, opioid consumption, intraoperative analgesic requirements, and postoperative complications were compared between the groups.
Read the detailed description
Postoperative pain is a common clinical problem following thyroidectomy and may negatively affect patient comfort, recovery, and overall surgical outcomes. Moderate postoperative pain is frequently observed after thyroid surgery, and inadequate pain control may lead to delayed mobilization, increased opioid consumption, and higher incidence of opioid-related adverse effects such as nausea, vomiting, respiratory depression, and sedation.
Regional anesthesia techniques have increasingly been used as part of multimodal analgesia strategies to improve postoperative pain control while reducing opioid requirements. The bilateral superficial cervical plexus block (BSCPB) is a regional anesthesia technique that can provide effective analgesia for surgical procedures involving the neck, including thyroidectomy, parathyroid surgery, and cervical lymph node excisions. When performed under ultrasound guidance, BSCPB allows accurate identification of anatomical structures and precise local anesthetic administration, which may improve block success and reduce potential complications.
The aim of this prospective study was to evaluate the analgesic efficacy of ultrasound-guided bilateral superficial cervical plexus block in patients undergoing thyroidectomy under general anesthesia.
A total of 40 patients aged between 18 and 65 years with American Society of Anesthesiologists (ASA) physical status I-III scheduled for elective thyroidectomy were included in the study. Patients were divided into two groups. In the block group (Group B), patients received ultrasound-guided bilateral superficial cervical plexus block using 10 ml of 0.5% bupivacaine on each side prior to surgery in addition to general anesthesia. In the control group (Group K), patients underwent thyroidectomy under general anesthesia without cervical plexus block.
Demographic characteristics, intraoperative hemodynamic parameters, anesthetic drug consumption, and intraoperative complications were recorded. Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) and Numeric Rating Scale (NRS) at 0, 2, 6, 12, and 24 hours after surgery. Postoperative tramadol consumption within the first 24 hours was also recorded. Additionally, postoperative complications such as nausea, vomiting, and pruritus were evaluated.
The primary objective of the study was to compare postoperative pain scores between the two groups. Secondary outcomes included intraoperative remifentanil consumption, postoperative tramadol consumption, hemodynamic parameters, and postoperative complications.
The findings of this study aim to determine whether ultrasound-guided bilateral superficial cervical plexus block provides improved postoperative analgesia and reduces opioid requirements in patients undergoing thyroidectomy.
- Conditions
- Postoperative Pain
- Being tested
- Ultrasound-Guided Bilateral Superficial Cervical Plexus Block, Standard general anesthesia
- Medical subject headings
- Pain, Postoperative
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
Intervention Description:
Patients received an ultrasound-guided bilateral superficial cervical plexus block prior to surgery. A total of 20 ml of 0.5% bupivacaine (10 ml per side) was injected along the posterior border of the sternocleidomastoid muscle using the three-injection technique. The block was performed under ultrasound guidance before induction of general anesthesia to provide perioperative analgesia.
Standard general anesthesiaProcedure or surgery
only general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Superficial Cervical Plexus Block | Experimental | Patients received ultrasound-guided bilateral superficial cervical plexus block using 10 ml of 0.5% bupivacaine on each side (total 20 ml) along the posterior border of the sternocleidomastoid muscle using the three-injection technique prior to thyroidectomy. The procedure was performed under ultrasound guidance in addition to standard general anesthesia. Receives: Procedure: Ultrasound-Guided Bilateral Superficial Cervical Plexus Block; Procedure: Standard general anesthesia |
| General Anesthesia Only | Active comparator | Patients underwent thyroidectomy under standard general anesthesia without cervical plexus block. Perioperative anesthesia management was performed according to routine institutional practice. Receives: Procedure: Standard general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity (VAS)
Postoperative pain assessed using the Visual Analog Scale (0-100 mm)
Measured: Within the first 24 hours after surgery
Postoperative pain intensity (NRS)
Description: Postoperative pain assessed using the Numeric Rating Scale (0-10)
Measured: Within the first 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 posted27 Mar 2026
- Study start15 Mar 2023
- Primary completion30 Jun 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzem SEN, University of Gaziantep
- Investigators
- Elzem Sen, Assoc Prof, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496970
- Sponsor's protocol ID
- 2023/17
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Postoperative Analgesic Effect of Ultrasound-Guided Bilateral Superficial Cervical Plexus Block in Patients Undergoing Thyroidectomy Under General Anesthesia: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07496970
- Acronym / sponsor ID
- 2023/17
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 27 Mar 2026 (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.
Patients undergoing thyroidectomy frequently experience moderate postoperative pain that may require opioid analgesics. Opioid use is associated with adverse effects such as nausea, vomiting, respiratory depression, and delayed recovery. Ultrasound-guided regional anesthesia techniques may provide effective postoperative analgesia while reducing opioid consumption.
The aim of this prospective randomized study was to evaluate the analgesic efficacy of ultrasound-guided bilateral superficial cervical plexus block (BSCPB) in patients undergoing thyroidectomy under general anesthesia. Patients were divided into two groups: a block group receiving BSCPB with 0.5% bupivacaine and a control group receiving general anesthesia alone. Postoperative pain scores, opioid consumption, intraoperative analgesic requirements, and postoperative complications were compared between the groups.
Detailed description
Postoperative pain is a common clinical problem following thyroidectomy and may negatively affect patient comfort, recovery, and overall surgical outcomes. Moderate postoperative pain is frequently observed after thyroid surgery, and inadequate pain control may lead to delayed mobilization, increased opioid consumption, and higher incidence of opioid-related adverse effects such as nausea, vomiting, respiratory depression, and sedation.
Regional anesthesia techniques have increasingly been used as part of multimodal analgesia strategies to improve postoperative pain control while reducing opioid requirements. The bilateral superficial cervical plexus block (BSCPB) is a regional anesthesia technique that can provide effective analgesia for surgical procedures involving the neck, including thyroidectomy, parathyroid surgery, and cervical lymph node excisions. When performed under ultrasound guidance, BSCPB allows accurate identification of anatomical structures and precise local anesthetic administration, which may improve block success and reduce potential complications.
The aim of this prospective study was to evaluate the analgesic efficacy of ultrasound-guided bilateral superficial cervical plexus block in patients undergoing thyroidectomy under general anesthesia.
A total of 40 patients aged between 18 and 65 years with American Society of Anesthesiologists (ASA) physical status I-III scheduled for elective thyroidectomy were included in the study. Patients were divided into two groups. In the block group (Group B), patients received ultrasound-guided bilateral superficial cervical plexus block using 10 ml of 0.5% bupivacaine on each side prior to surgery in addition to general anesthesia. In the control group (Group K), patients underwent thyroidectomy under general anesthesia without cervical plexus block.
Demographic characteristics, intraoperative hemodynamic parameters, anesthetic drug consumption, and intraoperative complications were recorded. Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) and Numeric Rating Scale (NRS) at 0, 2, 6, 12, and 24 hours after surgery. Postoperative tramadol consumption within the first 24 hours was also recorded. Additionally, postoperative complications such as nausea, vomiting, and pruritus were evaluated.
The primary objective of the study was to compare postoperative pain scores between the two groups. Secondary outcomes included intraoperative remifentanil consumption, postoperative tramadol consumption, hemodynamic parameters, and postoperative complications.
The findings of this study aim to determine whether ultrasound-guided bilateral superficial cervical plexus block provides improved postoperative analgesia and reduces opioid requirements in patients undergoing thyroidectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral Superficial Cervical Plexus Block | Experimental | Procedure: Ultrasound-Guided Bilateral Superficial Cervical Plexus Block, Procedure: Standard general anesthesiaPatients received ultrasound-guided bilateral superficial cervical plexus block using 10 ml of 0.5% bupivacaine on each side (total 20 ml) along the posterior border of the sternocleidomastoid muscle using the three-injection technique prior to thyroidectomy. The procedure was performed under ultrasound guidance in addition to standard general anesthesia. |
| General Anesthesia Only | Active comparator | Procedure: Standard general anesthesiaPatients underwent thyroidectomy under standard general anesthesia without cervical plexus block. Perioperative anesthesia management was performed according to routine institutional practice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 18 and 75 years American Society of Anesthesiologists (ASA) physical status I-III Scheduled for elective surgery under general anesthesia Ability to provide written informed consent
Key exclusion criteria (1 listed)
- Allergy to local anesthetic agents Coagulation disorders or anticoagulant use Infection at the injection site Severe cardiac, respiratory, hepatic, or renal disease Pregnancy or breastfeeding Inability to understand pain scoring systems (VAS/NRS)
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 BlockIntervention Description: Patients received an ultrasound-guided bilateral superficial cervical plexus block prior to surgery. A total of 20 ml of 0.5% bupivacaine (10 ml per side) was injected along the posterior border of the sternocleidomastoid muscle using the three-injection technique. The block was performed under ultrasound guidance before induction of general anesthesia to provide perioperative analgesia. | Procedure or surgery | Bilateral Superficial Cervical Plexus Block |
| Standard general anesthesiaonly general anesthesia | Procedure or surgery | Bilateral Superficial Cervical Plexus Block, General Anesthesia Only |
Primary outcome
Postoperative pain intensity (VAS)
Time frame: Within the first 24 hours after surgery
Postoperative pain assessed using the Visual Analog Scale (0-100 mm)
Postoperative pain intensity (NRS)
Time frame: Within the first 24 hours after surgery
Description: Postoperative pain assessed using the Numeric Rating Scale (0-10)
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 27 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Elzem Sen, Assoc Prof principal investigator
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Bilateral Superficial Cervical Plexus Block and Standard general anesthesia in people with Postoperative Pain, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 27 Mar 2026. 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 Turkey (Türkiye). 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?
Postoperative pain intensity (VAS) (time frame: Within the first 24 hours after surgery). The study lists 2 primary outcomes in all. 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 27 Mar 2026.