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NCT Number: NCT06789575

Comparison of Bupivacaine Wound Infiltration Versus Wound Instillation to Minimize Postoperative Pain After Thyroid Surgery

Pain management following thyroidectomies, which can cause mild to moderate postoperative pain, particularly in the first 24 hours following surgery, has received little attention . The incision of the wound, neck hyperextension, retraction of the wound margins during surgery, and dissection are the main reasons of post-thyroidectomy discomfort . After thyroid surgery, pain management improves patients' quality of life and facilitates a speedy return to regular daily activities.

the aim of the study to evaluate the effects of bupivacaine instillation after thyroidectomy against infiltration into the surgical field in order to reduce postoperative discomfort following thyroid surgery.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Pain management following thyroidectomies, which can cause mild to moderate postoperative pain, particularly in the first 24 hours following surgery, has received little attention . The incision of the wound, neck hyperextension, retraction of the wound margins during surgery, and dissection are the main reasons of post-thyroidectomy discomfort . After thyroid surgery, pain management improves patients' quality of life and facilitates a speedy return to regular daily activities.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Normal thyroid function patients of both genders scheduled for thyroid surgery will included in this study
  • If they are over the age of 18
  • If they had an ASA score (American Society of Anesthesiology) I, II.
  • A Score of Mallampati I , II.

Exclusion criteria

  • Patient refused to participate in the study.
  • Patients will be excluded if they have any analgesic medication or corticosteroid drug prior surgery or
  • A known or suspected allergy to local anesthetics,
  • if the duration of surgery is greater than 5 h and if a major complication of surgery or anesthesia (major bleeding, allergy to anesthetic products).
  • Patients who have lateral neck dissection associated with Thyroid surgery are excluded.

Treatment and study plan

Bupivacaine

Drug

the patients will receive the content of a syringe (10 ml of bupivacaine 0.25%)

Adrenaline

Drug

the patients will receive the content of a syringe 15 μg adrenaline

Lidocaine (drug)

Drug

the patients will receive the content of a syringe 70 ml Lidocaine .

Primary outcomes

  1. Total analgesic consumption

    Time frame: 24 hours

    Total analgesic consumption at 1st. 24 hours postoperative

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Hussien Abdel hakim Mohamed, residant doctor

CONTACT

[email protected]

+201011854982

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

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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