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Completed

NCT Number: NCT02112370

Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy

To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in BABA endoscopic and robotic thyroidectomy.

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Key information

Conditions

Thyroid Neoplasm Endocrine Gland Neoplasms Endocrine System Diseases Goiter Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

About this study

Diluted ropivacaine with epinephrine is injected into the subcutaneous space to relieve pain and reduce bleeding during procedures. The synergistic effect of ropivacaine with epinephrine can contribute to patients' welfare, such as relieving pain and structuring the hemodynamic stability.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of thyroid neoplasm or benign goiter
  • Scheduled for BABA endoscopic or robotic thyroidectomy

Exclusion criteria

  • Completion thyroidectomy
  • Modified radical neck dissection
  • Allergy history
  • Stroke history
  • Uncontrolled hypertension
  • Uncontrolled diabetes
  • Coagulopathy
  • Severe cardiovascular disease
  • Severe pulmonary disease
  • Chronic kidney disease
  • Pregnant

Treatment and study plan

Ropivacaine with epinephrine injection

Drug

1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection for the experiment group.

Other names: Hanlim ropiva injection 7.5 mg/mL (20cc), Insurance code: A37804211, Jeil epinephrine injection 1 mg/mL (1cc), Insurance code: A04900341

Placebo

Other

100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.

Other names: CJ 0.9% Normal Saline injection 100cc, Insurance code: A11601752

Primary outcomes

  1. NRS Pain Scores for the First 12 Hours

    Time frame: Postoperative 12 hours

    The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location.

    Range: 0(minimal pain, better outcome) ~ 10(maximum pain, worse outcome)

    Unlike the general NRS pain score as reported in the "post-operative 48 hour" result which deals with post-operative discomfort in general, this outcome measures the pain score of the specific location in which flap dissection had taken place.

Secondary outcomes

  1. Maximum of Measured Systolic Blood Pressures

    Time frame: participants were followed for the duration of the operation, an average of approximately 2.5 hours

    The maximal systolic blood pressure is monitored during surgery.

  2. Maximum of Measured Diastolic Blood Pressures

    Time frame: participants were followed for the duration of the operation, an average of approximately 2.5 hours

    The maximal diastolic blood pressure is monitored during surgery.

  3. Maximum of Measured Heart Rates

    Time frame: participants were followed for the duration of the operation, an average of approximately 2.5 hours

    The maximal heart rate is monitored during surgery.

  4. Blood Loss Amount

    Time frame: participants were followed for the duration of the operation, an average of approximately 2.5 hours

    The blood loss amount is estimated at the end of surgery.

  5. Operation Time

    Time frame: participants were followed for the duration of the operation, an average of approximately 2.5 hours

    The amount of time taken from start to the end of surgery

  6. NRS Change

    Time frame: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation

    Change in NRS score a with time The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location.

    Range: 0(minimal pain, better outcome) ~ 10(maximum pain, worse outcome)

  7. Pain Killer Dose

    Time frame: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation

    Change in pain killer usage with time

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study title

Phase 3 Study of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy

Acronym: REBT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 11, 2014
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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