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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-05-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Thyroid Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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 ).

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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

Adrenaline

Intervention Type DRUG

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

Lidocaine (drug)

Intervention Type DRUG

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

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 ).

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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

Adrenaline

Intervention Type DRUG

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

Lidocaine (drug)

Intervention Type DRUG

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

Interventions

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Bupivacaine

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

Intervention Type DRUG

Adrenaline

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

Intervention Type DRUG

Lidocaine (drug)

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No