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Local Anesthetic Infiltration for Pain Control After Orthopedic Wide Excision

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07753629
Enrollment
58
Registered
2026-08-07
Start date
2026-08-07
Completion date
2028-07-31
Last updated
2026-08-07

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

Conditions

Postoperative Pain, Wide Excision

Brief summary

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.

Interventions

COMBINATION_PRODUCTRopivacaine-Morphine-Ketorolac-Epinephrine-Cefuroxime Mixture

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.

DRUGCefuroxime-Saline Mixture

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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

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

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Cumulative Opioid Consumption Within 24 Hours After Surgery24 hours after surgeryTotal opioid consumption during the first 24 hours postoperatively, converted to intravenous morphine milligram equivalents (MME).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026