A prospective study investigating the impact of peripheral nerve block on opioid consumption.

Effect of Peripheral Nerve Blocks on Postoperative Opioid Consumption after SCIP Free Flap Reconstruction for Below-Knee Defects: A Randomized Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0011621

Enrollment

Registered

2026-02-19

Start date

2026-03-03

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

None listed

Interventions

Procedure/Surgery : 1. General Postoperative Analgesic Protocol (Common to Both Groups)All participants in this study will receive a standardized postoperative analgesic regimen. Intravenous Patient-C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 to 80 years. 2. Patients scheduled for reconstructive surgery using a SCIP free flap for tissue defects in the area below the knee. 3. Patients who have received a full explanation of the study’s purpose and procedures and are able to provide written informed consent to participate.

Exclusion criteria

Exclusion criteria: 1. Refusal to participate or failure to provide informed consent after explanation of the study's purpose and procedures 2. Bradycardia (Heart Rate < 50 bpm) 3. Diabetes Mellitus (DM) 4. Peripheral neuropathy 5. History of or currently suspected opioid addiction 6. History of hypersensitivity or serious adverse reactions to fentanyl or other opioids (e.g., severe nausea, vomiting, respiratory depression, anaphylaxis, or profound sedation) 7. History of allergy to local anesthetics (e.g., ropivacaine) 8. Infection at the injection site or hemorrhagic disorders 9. Cases where nerve block is deemed inappropriate due to the use of anticoagulants 10. Cases where opioid pharmacokinetics are expected to be significantly altered due to severe hepatic or renal failure 11. Pregnant or lactation 12. Transferred to the ICU with postoperative mechanical ventilation

Design outcomes

Primary

Measure	Time frame
cumulative fentanyl use (µg)	—

Secondary

Measure	Time frame
Cumulative fentanyl use (µg);Donor site Score;Recipient site NRS Score;Time to first rescue fentanyl (NRS score = 4);Cumulative number of fentanyl doses at 24, 48, 72, 96, and 120 hours postoperative;Cumulative number of breakthrough pain episodes at 24, 48, 72, 96, and 120 hours postoperatively	—

Countries

Korea, Republic of

Contacts

Public ContactHyun Suk Suh

Asan Medical Center

slimtj@hanmail.net+82-2-3010-3600

Outcome results