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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thyroid Surgery
• Intervention / Treatment: Drug: Bupivacaine; Drug: Adrenaline; Drug: Lidocaine (drug)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ahmed Hussien Abdel hakim Mohamed, residant doctor; Phone Number: +201011854982; Email: Ahmed.16266082@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group S; mixture will instilled over the incision before the closure of the incision the patients will receive the content of a syringe (10 ml of bupivacaine 0.25% , 15 μg adrenaline and 70 ml Lidocaine ).	Drug: Bupivacaine; the patients will receive the content of a syringe (10 ml of bupivacaine 0.25%); Drug: Adrenaline; the patients will receive the content of a syringe 15 μg adrenaline; Drug: Lidocaine (drug); the patients will receive the content of a syringe 70 ml Lidocaine .
Active Comparator: Group F; will recieve the mixture by injection inside the wound before the closure of the incision the patients will receive the content of a syringe (10 ml of bupivacaine 0.25% , 15 μg adrenaline and 70 ml Lidocaine ).	Drug: Bupivacaine; the patients will receive the content of a syringe (10 ml of bupivacaine 0.25%); Drug: Adrenaline; the patients will receive the content of a syringe 15 μg adrenaline; Drug: Lidocaine (drug); the patients will receive the content of a syringe 70 ml Lidocaine .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total analgesic consumption	Total analgesic consumption at 1st. 24 hours postoperative	24 hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: January 18, 2025
• First Submitted That Met QC Criteria: January 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 18, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Neurotransmitter Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: Wound Infilt/InstThyroid Surg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes