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

Phase 3

Not yet recruiting

• Conditions: Thyroid Surgery
• Interventions: Drug: Bupivacaine; Drug: Adrenaline; Drug: Lidocaine (drug)

• Registration Number: NCT06789575
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-18
• Study First Submitted QC: 2025-01-18
• Last Update Submitted: 2025-01-18
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23
• Study Start: 2025-03-01
• Primary Completion: 2026-03-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group S	Bupivacaine	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 ).
Group S	Adrenaline	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 ).
Group S	Lidocaine (drug)	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 ).
Group F	Bupivacaine	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 ).
Group F	Adrenaline	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 ).
Group F	Lidocaine (drug)	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 ).

Primary Outcome Measures

Name	Time	Method
Total analgesic consumption	24 hours	Total analgesic consumption at 1st. 24 hours postoperative