Menu
Not yet recruiting NCT07753629

Local Anesthetic Infiltration for Pain Control After Orthopedic Wide Excision

No phase Interventional Wide Excision Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ropivacaine-Morphine-Ketorolac-Epinephrine-Cefuroxime Mixture, Cefuroxime-Saline Mixture.
Who it may be relevant to
Registry conditions: Wide Excision, Postoperative Pain. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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 product Ropivacaine-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.
  • Drug Cefuroxime-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.

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07753629 · LIA-WE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗