Local Anesthetic Infiltration for Pain Control After Orthopedic Wide Excision

Sponsor
Seoul National University Hospital
Study ID
NCT07753629
Status
Not Yet Recruiting

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Conditions

  • Postoperative Pain
  • Wide Excision

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 7, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Local Anesthetic Infiltration Group
    Participants receive a subcutaneous/subfascial injection at the incision site before skin closure, containing 0.75% ropivacaine 20 mL, morphine 10 mg, ketorolac 30 mg, epinephrine 0.3 mg, and cefuroxime 750 mg (total 50 mL).
  • Placebo Comparator: Placebo Control Group
    Participants receive a subcutaneous/subfascial injection at the incision site before skin closure, containing cefuroxime 750 mg and normal saline (total 50 mL).

Primary Outcome Measure

Cumulative Opioid Consumption Within 24 Hours After Surgery [ Time Frame: 24 hours after surgery ]

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