- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07496970
Bilateral Cervical Plexus Block for Postoperative Pain After Thyroidectomy
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gaziantep, Turkey (Türkiye), 27410
- Gaziantep University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bilateral Superficial Cervical Plexus Block
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.
|
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.
only general anesthesia
|
|
Active Comparator: General Anesthesia Only
Patients underwent thyroidectomy under standard general anesthesia without cervical plexus block.
Perioperative anesthesia management was performed according to routine institutional practice.
|
only general anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity (VAS)
Time Frame: Within the first 24 hours after surgery
|
Postoperative pain assessed using the Visual Analog Scale (0-100 mm)
|
Within the first 24 hours after surgery
|
|
Postoperative pain intensity (NRS)
Time Frame: Within the first 24 hours after surgery
|
Description: Postoperative pain assessed using the Numeric Rating Scale (0-10)
|
Within the first 24 hours after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elzem Sen, Assoc Prof, University of Gaziantep
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain
-
National and Kapodistrian University of AthensCompletedPostoperative Pain, Acute | Postoperative Pain, Chronic | Postoperative Pain After Thoracic SurgeryGreece
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingPostoperative Pain | Postoperative Pain Management | Postoperative Pain in Orthopaedics
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Children's National Research InstituteVentureWellRecruitingPostoperative Pain | Acute Pain | Acute Pain, PostoperativeUnited States
-
University of MalayaActive, not recruitingPostoperative Pain | Postoperative Pain ManagementMalaysia
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
Clinical Trials on Ultrasound-Guided Bilateral Superficial Cervical Plexus Block
-
Cangzhou Hospital of Integrated Traditional Chinese...Completed
-
University Hospital DubravaActive, not recruitingThyroid Cancer | Thyroid and Parathyroid Surgery | Hyperthyreosis and Goiter | Surgical Stress ResponseCroatia
-
University Hospital, LinkoepingAhmed Mohamed Abdelrahman; Mahmoud Ahmed Mewafy; Abdelrhman Alshawadfy; Haidi Abd-Elzaher and other collaboratorsCompletedPostoperative Pain | Analgesia Obtained With a Local Wound Infiltration of Lidocain | Analgesia Obtained With a Ultrasound Guided Cervical Plexus Block Using LidocainSweden
-
Sanliurfa Mehmet Akif Inan Education and Research...RecruitingCerebral Perfusion | Interscalene Block | Superficial Cervical Block | Shoulder SurgeriesTurkey (Türkiye)
-
Tokat Gaziosmanpasa UniversityCompleted
-
Cantonal Hospital of St. GallenCompletedThyroidectomySwitzerland
-
Cleveland Clinic Akron GeneralCompletedPain | Superficial Cervical Plexus BlockUnited States
-
Beijing Tiantan HospitalCompletedPlexus Block;Analgesia;NeurosurgeryChina
-
Cairo UniversityCompletedPostoperative Nausea and VomitingEgypt
-
University Tunis El ManarCompletedChronic Pain | ThyroidectomyTunisia