Wide ExcisionNCT07753629
Local Anesthetic Infiltration for Pain Control After Orthopedic Wide Excision
A study testing Ropivacaine-Morphine-Ketorolac-Epinephrine-Cefuroxime Mixture and Cefuroxime-Saline Mixture in people with Wide Excision and Postoperative Pain, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Wide Excision, Postoperative Pain
- What is being tested?
- Ropivacaine-Morphine-Ketorolac-Epinephrine-Cefuroxime Mixture and Cefuroxime-Saline Mixture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 7 Aug 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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
- Being tested
- Ropivacaine-Morphine-Ketorolac-Epinephrine-Cefuroxime Mixture, Cefuroxime-Saline Mixture
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine-Morphine-Ketorolac-Epinephrine-Cefuroxime MixtureCombination 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 MixtureDrug
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Cefuroxime-Saline Mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Opioid Consumption Within 24 Hours After Surgery
Total opioid consumption during the first 24 hours postoperatively, converted to intravenous morphine milligram equivalents (MME).
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start7 Aug 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wide ExcisionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Hoon Koo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753629
- Sponsor's protocol ID
- LIA-WE
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07753629
- Acronym / sponsor ID
- LIA-WE
- Conditions
- Wide Excision, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Anesthetic Infiltration Group | Experimental | Combination Product: Ropivacaine-Morphine-Ketorolac-Epinephrine-Cefuroxime MixtureParticipants 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 Control Group | Placebo comparator | Drug: Cefuroxime-Saline MixtureParticipants receive a subcutaneous/subfascial injection at the incision site before skin closure, containing cefuroxime 750 mg and normal saline (total 50 mL). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine-Morphine-Ketorolac-Epinephrine-Cefuroxime MixtureA 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. | Combination product | Local Anesthetic Infiltration Group |
| Cefuroxime-Saline MixtureA 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. | Drug | Placebo Control Group |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine-Morphine-Ketorolac-Epinephrine-Cefuroxime Mixture and Cefuroxime-Saline Mixture in people with Wide Excision and Postoperative Pain, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Opioid Consumption Within 24 Hours After Surgery (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.