Postoperative Pain Cholelithiasis Laparoscopic Cholecystectomy Postoperative Pain Ambulatory Surgical Procedures Ketamine Lidocaine Magnesium Sulfate Morphine
Conditions
Interventions
Participants in this experimental group will receive an intravenous infusion of the KLM regimen, consisting of lidocaine 1.5 mg/kg, ketamine 0.15 mg/kg, and magnesium sulfate 30 mg/kg. The medication
Experimental Drug,Placebo Comparator Drug
KLM Regimen,NSS
Sponsors
Sawanpracharak Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients scheduled for elective laparoscopic cholecystectomy under the One-Day Surgery (ODS) program at Sawanpracharak Hospital. 2. American Society of Anesthesiologists (ASA) physical status I or II. 3. Body Mass Index (BMI) less than 30 kg/m2. 4. Ability to communicate in Thai, understand the Numerical Rating Scale (NRS) for pain assessment, and comprehend the functional recovery assessment steps. 5. Willingness to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Physiological and physical limitations increasing the risk of complications, including age < 18 or > 65 years, BMI >= 30 kg/m2, or ASA physical status >= III. 2. Medical contraindications to the KLM regimen, including a history of allergy to lidocaine, ketamine, or magnesium sulfate, severe hepatic impairment (Child-Pugh C), chronic renal failure, or a history of epilepsy. 3. Cardiovascular abnormalities, including uncontrolled hypertension (systolic BP >= 180 mmHg or diastolic BP >= 110 mmHg), bradycardia (2nd-3rd degree heart block), or cardiac conduction abnormalities. 4. Neuropsychiatric limitations or risky behaviors, including a history of psychiatric disorders or active psychosis, a history of substance or alcohol abuse, or chronic opioid use (continuous use for more than 3 months). 5. Specific medical and surgical conditions affecting study outcomes, including pregnancy or lactation, acute cholecystitis, or inability to assess pain and communicate according to the research protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour cumulative morphine consumption At 24 hours postoperatively Total morphine dose in milligrams (mg) | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative pain intensity At 0, 30, and 60 minutes in the PACU Numerical Rating Scale (NRS, 0-10),Incidence of postoperative nausea and vomiting (PONV), sheivering, sedation and dizziness From immediately post-operation until discharge Presence or absence,Incidence of perioperative hemodynamic instability Before intervention, after intervention, after endotracheal intubation, and after surgical incision Incidence of hypertension, hypotension, or tachycardia (defined as more than 20% change in BP or HR from baseline),Time to first ambulation Assessed every 2 hours until successful ambulation Time recorded via prompted ambulation protocol,Incidence of delayed emergence At the end of surgery Presence or absence of delayed emergence (defined as time from the discontinuation of anesthetics to extubation exceeding 30 minutes) | — |
Countries
Thailand
Contacts
Public ContactChompoonik Jiemjitpolchai
Department of Anesthesiology, Sawanpracharak Hospital, Nakhonsawan, Thailand
Outcome results
None listed