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NCT Number: NCT07753629

Local Anesthetic Infiltration for Pain Control After Orthopedic Wide Excision

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Unwilling to provide informed consent
  • History of allergy to local anesthetics
  • History of chronic pain
  • Use of opioid analgesics within 24 hours before surgery
  • Active infection at the surgical site

Treatment and study plan

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.

Primary outcomes

  1. Cumulative Opioid Consumption Within 24 Hours After Surgery

    Time frame: 24 hours after surgery

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Analgesic Effect of Subcutaneous Local Infiltration Anesthesia Before Skin Closure on Postoperative Pain in Patients Undergoing Orthopedic Wide Excision: A Prospective Double-Blind Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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