Local Anesthetic Infiltration for Pain Control After Orthopedic Wide Excision

ConditionsWide Excision Postoperative Pain

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19+

SponsorSeoul National University Hospital

About this trial

This study evaluates whether injecting a local anesthetic mixture (ropivacaine, morphine, ketorolac, and epinephrine) under the skin at the incision site before wound closure reduces pain after orthopedic wide excision surgery for bone or soft tissue tumors. Participants will be randomly assigned to receive either the local anesthetic mixture or a saline control injection. Neither participants nor the study team assessing outcomes will know which treatment was given. The main goal is to determine whether this injection reduces the amount of opioid pain medication needed during the first 24 hours after surgery. The study will also assess pain scores, nausea and vomiting, and quality of recovery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled to undergo elective orthopedic wide excision surgery under general anesthesia

American Society of Anesthesiologists (ASA) Physical Status Classification 1, 2, or 3

Age 19 years or older

Disqualifiers

Unwilling to provide informed consent

History of allergy to local anesthetics

History of chronic pain

Use of opioid analgesics within 24 hours before surgery

Trial design

Design model

Parallel

Treatments tested in this trial

Ropivacaine-Morphine-Ketorolac-Epinephrine-Cefuroxime Mixture
Combination product
A single subcutaneous/subfascial injection administered at the incision site before skin closure, consisting of 0.75% ropivacaine 20 mL, morphine sulfate 10 mg, ketorolac 30 mg, epinephrine 0.3 mg, and cefuroxime 750 mg, mixed to a total volume of 50 mL.
Cefuroxime-Saline Mixture
Drug
A single subcutaneous/subfascial injection administered at the incision site before skin closure, consisting of cefuroxime 750 mg and normal saline, mixed to a total volume of 50 mL.

Treatment groups

58 Participants

are divided into 2 treatment groups

Group A: Local Anesthetic Infiltration GroupExperimental treatment 1 intervention

Group B: Placebo Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Cumulative Opioid Consumption Within 24 Hours After Surgery

Total opioid consumption during the first 24 hours postoperatively, converted to intravenous morphine milligram equivalents (MME).

Time frame

24 hours after surgery

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: