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

NCT06789575 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: Wound Infilt/InstThyroid Surg
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thyroid Surgery

Outcome Measures

Primary Outcomes (1)

• Total analgesic consumption

  Total analgesic consumption at 1st. 24 hours postoperative

  24 hours

Study Arms (2)

Group S

ACTIVE COMPARATOR

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; Drug: Adrenaline; Drug: Lidocaine (drug)

Group F

ACTIVE COMPARATOR

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; Drug: Adrenaline; Drug: Lidocaine (drug)

Interventions

Bupivacaine DRUG

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

Group F; Group S

Adrenaline DRUG

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

Group F; Group S

Lidocaine (drug) DRUG

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

Group F; Group S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Bupivacaine; Epinephrine; Lidocaine; Pharmaceutical Preparations

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides

Central Study Contacts

Ahmed Hussien Abdel hakim Mohamed, residant doctor

CONTACT

+201011854982; Ahmed.16266082@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 23, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 23, 2025

Record last verified: 2025-01