Local Anesthetic Infiltration for Pain Control After Orthopedic Wide Excision

NCT07753629 | Not Yet Recruiting

• 1 other identifier: LIA-WE
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wide Excision; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Cumulative Opioid Consumption Within 24 Hours After Surgery

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

  24 hours after surgery

Study Arms (2)

Local Anesthetic Infiltration Group

EXPERIMENTAL

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).

Combination Product: Ropivacaine-Morphine-Ketorolac-Epinephrine-Cefuroxime Mixture

Placebo Control Group

PLACEBO COMPARATOR

Participants receive a subcutaneous/subfascial injection at the incision site before skin closure, containing cefuroxime 750 mg and normal saline (total 50 mL).

Drug: Cefuroxime-Saline Mixture

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.

Local Anesthetic Infiltration Group

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.

Placebo Control Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start: August 7, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share