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

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06789575
Enrollment
102
Registered
2025-01-23
Start date
2025-03-01
Completion date
2027-05-01
Last updated
2025-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Surgery

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.

Interventions

DRUGBupivacaine

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

DRUGAdrenaline

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

DRUGLidocaine (drug)

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Total analgesic consumption24 hoursTotal analgesic consumption at 1st. 24 hours postoperative

Contacts

Primary ContactAhmed Hussien Abdel hakim Mohamed, residant doctor
Ahmed.16266082@med.aun.edu.eg+201011854982

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026