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Application of Opioid-Free Anesthesia in Same-Day Surgery Laparoscopic Inguinal Hernia Repair

Application of Opioid-Free Anesthesia in Same-Day Surgery Laparoscopic Inguinal Hernia Repair (OFALIH study): A non-inferiority randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098054
Enrollment
Unknown
Registered
2025-02-28
Start date
2023-08-12
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Lnguinal hernia

Interventions

Opioid-free general anesthesia group (OFA group):Opioid-free general anesthesia
Opioid anesthesia group (OA group):Opioid anesthesia

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 18 < age < 70 years; ASA Grading I.~III; Gender is not limited; 18<BMI<30kg/m^2;Able to understand and comply with the study protocol, able to communicate, and agree to sign informed consent

Exclusion criteria

Exclusion criteria: Incarcerated hernia; pregnant women; expected operation duration > 1h; severe heart disease (NYHA cardiac function grade > 3), severe renal insufficiency (serum creatinine > 1.8mg/dL (159.1µmol/L) or receiving renal replacement therapy), severe liver insufficiency (modified Child - Pugh grade C); severe arrhythmia, bradycardia, sick sinus syndrome, heart block; severe coagulation disorder (PT prolongation = 6s or INR > 1.4), abnormal platelet count (platelet count > 50 × 10^9/L); allergic to study drugs; history of drug abuse such as opioids; other contraindications for anesthesia or surgery; refusal to sign the informed consent form; participation in other clinical trials.

Design outcomes

Primary

MeasureTime frame
The degree of acute postoperative pain (the area under the AUC curve drawn by the VAS score recorded from T5 to T9).;

Secondary

MeasureTime frame
VAS score when getting out of bed and moving around at 6 hours after surgery (T7*).;The number of times ketorolac tromethamine is required for remedial analgesia within 24 hours after surgery.;PCIA utilization rate;Incidence of adverse events;Quality of recovery score (QoR - 15);Daytime ward discharge failure rate;The incidence of CPIP at 3 months after surgery.;Intraoperative hemodynamic parameters (MAP; HR).;

Countries

China

Contacts

Public ContactBo Lulong

Shanghai Changhai Hospital

nbastars@126.com+86 138 1728 3189

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026