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NCT Number: NCT02981095

Effect of Bupivacaine Application on Postthyroidectomy Pain

Investigators aimed to evaluate the impact of bupivacaine administration into the surgical field after total thyroidectomy on post-operative pain and analgesic requirement with a double-blind, prospective, clinical, randomized study.

Pain assessment was performed with the visual analog score (VAS). Participants were pre-operatively, divided into two groups randomly to receive either bupivacaine or not. One group received a 10 ml of bupivacaine solution while the other group was treated with the same volume of 0.9% sodium chloride (NaCl) through the drain after completion of total thyroidectomy procedure. All participants were anesthetized and operated with the same anesthesia and surgical team.

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Key information

Conditions

Thyroid Disease Agnosia Analgesia Endocrine System Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects need to be operated for thyroid diseases

Exclusion criteria

  • History of previous thyroid disease,
  • History of previous neck operations,
  • Hypersensitivity to the drugs that were used in the study protocol,
  • Spinal bone disease,
  • Depression,
  • Kidney failure,
  • Heart failure,
  • Liver failure,
  • Pulmonary failure,
  • Mental retardation,
  • Subjects not able to ascertain pain scoring with the visual analog score (VAS),
  • Patients with American Society of Anesthesiologists (ASA) scores III or higher,
  • Expected airway difficulty according to Mallampati scores,
  • Sedative, steroid, and chronic analgesic drug users,
  • Alcoholics

Treatment and study plan

Thyroidectomy

Procedure

Thyroidectomy performed by the same surgical and anesthesia team

Bupivacaine

Drug

bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.

Saline Solution

Drug

%0.9 sodium chloride solution, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.

Primary outcomes

  1. Post-operative pain in 8 hours after surgery using VAS

    Time frame: 8th hour

    Evaluation of the pain through the post-operative first 8 hours using VAS

Secondary outcomes

  1. Post-operative pain in in first post-operative day using VAS

    Time frame: 1 day

    Evaluation of the pain through the first post-operative day using VAS

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Bupivacaine Application Reduces Postthyroidectomy Pain: Cerrahpaşa Experience

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2016
Registry last updated
Dec 2, 2016

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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