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

Assiut University

Status and phase: Not yet enrolling; Phase 3

Conditions: Thyroid Surgery

Treatments: Drug: Adrenaline; Drug: Bupivacaine; Drug: Lidocaine (drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT06789575

Wound Infilt/InstThyroid Surg

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups

Group S

Active Comparator group

Description:

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 ).

Treatment:

Drug: Lidocaine (drug)

Drug: Bupivacaine

Drug: Adrenaline

Group F

Active Comparator group

Description:

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 ).

Treatment:

Drug: Lidocaine (drug)

Drug: Bupivacaine

Drug: Adrenaline