Bilateral Superficial Cervical Block for Thyroidectomy

Evaluation of the Postoperative Analgesic Efficacy of Bilateral Superficial Cervical Block for Thyroidectomy and Mini Incision Under General Balanced Anesthesia: a Randomized, Triple Masked, Placebo Controlled Trial.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01171885

Enrollment

120

Registered

2010-07-29

Start date

2009-07-31

Completion date

2011-12-31

Last updated

2010-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Pain

Keywords

Superficial cervical block, Thyroidectomy, Pain

Brief summary

The objective of this study is to compare the postoperative analgesia afforded by bilateral superficial cervical block using different concentrations of local anesthetic (ropivacaine) in patients undergoing total thyroidectomy for the mini-incision technique, performed by the same surgical team.

Detailed description

In this study we will evaluate the efficacy of bilateral superficial cervical block associated with balanced general anesthesia with remifentanil as opioid of choice in preventing postoperative pain in patients who underwent total thyroidectomy with mini incision without neck dissection.A hundred and twenty patients ASA I - II will be assessed and allocated randomly (through a table of random numbers) into three groups for analgesia for post-operative: Group 1: bilateral superficial cervical block with 20 ml of 0.9% saline (placebo); Group 2: bilateral superficial cervical block with 20 ml ropivacaine 0.25%; Group 3: bilateral superficial cervical block with 20 ml ropivacaine 0.5%.

Interventions

DRUG0.9% saline

20 ml of 0.9% saline

DRUGRopivacaine

20 ml of Ropivacaine 0.25%.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age greater than 18 years * Agreed to participate in the study and sign the consent form * ASA I-II * Scheduled to undergo total thyroidectomy without neck dissection under general balanced anesthesia.

Exclusion criteria

* Clinical history or laboratory tests suggestive of bleeding disorder * Mental or cognitive deficit in existence, which makes it impossible to understand the patient visual analog scale of pain or the study protocol * Body mass index greater than 45 * History of allergy to local anesthetics * Intolerance or contraindication to any medication used in the study * Skin infection at the site of the blockade * Patients requiring neck dissection * Pregnancy * Preoperative use of opioid analgesics or non-opioids, corticosteroids or anti inflammatory non steroidal * Patient's refusal to participate in the study * Need for emergency reintervention within the first 24 hours postoperatively

Design outcomes

Primary

Measure	Time frame
Post operative pain assessment according to Visual Analogue Scale	24 Hours

Secondary

Measure	Time frame
Consumption of morphine	24 Hours

Countries

Brazil

Contacts

Primary ContactCarlos Leonardo A Boni, MD

leonardoboni@gmail.com00553191851959

Backup ContactYerkes P Silva, PhD

yerkesps@uol.com.br00553199933384

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026