Clinical trial

The Effect of Intraoperative Lidocaine Infusion and Intraoperative Lidocaine Combined With Ketamine Infusion on Opioid Consumption After Laparoscopic Bariatric Surgery: A Randomized Controlled Trial

Name
610/2563(IRB3)
Description
The most effective long-term treatment for obesity is bariatric surgery, however, postoperative pain control is challenging in these group of population. Opioid-sparing technique with multimodal analgesia is recommended but the evidence supported is still limited. Multimodal analgesia, particularly lidocaine and ketamine, has been used effectively in various type of surgery. However, the evidence supported their use in obese patients undergoing bariatric surgery is limited.
Trial arms
Trial start
2021-04-01
Estimated PCD
2024-06-30
Trial end
2024-08-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Lidocaine Hydrochloride
lidocaine will be given 1.5 mg/kg bolus at induction then 2mg/kg/hr until the end of surgery.
Arms:
Lidocaine, Lidocaine and Ketamine
Other names:
Li
Ketamine
Ketamine will be given 0.35 mg/kg bolus at induction then 0.2 mg/kg/hr until the end of surgery.
Arms:
Lidocaine and Ketamine
Other names:
Ke
Placebo
Normal saline will be given with the same rate of lidocaine or ketamine.
Arms:
Lidocaine, Placebo
Other names:
Normal Saline
Size
87
Primary endpoint
Opioid consumption
24-hour
Score of post-extubation cough
up to 24 hours (at extubation period after surgery finished)
Eligibility criteria
Inclusion Criteria: 1. Adults patients age older than 18 years. 2. Body mass index more than 30 kg/m2. 3. Scheduled for laparoscopic bariatric surgery, including laparoscopic sleeve gastrectomy, robotic-assisted laparoscopic sleeve gastrectomy, laparoscopic Roux-en-Y gastric bypass surgery or robotic-assisted laparoscopic gastric bypass. Exclusion Criteria: 1. Patient refusal. 2. Inability to communicate or read in Thai language. 3. Allergic to lidocaine or ketamine. 4. History of opioid use within 2 weeks before surgery 5. Cardiovascular disorder, including high grade atrioventricular block (second degree or third degree), history of coronary artery disease, poor controlled hypertension. 6. History of stroke, intracranial hemorrhage or intracranial mass 7. Cognitive impairment 8. Schizophrenia or history of antipsychotic drugs 9. Pregnant or breast-feeding patients 10. Conversion to open surgery
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 87, 'type': 'ESTIMATED'}}
Updated at
2024-05-09

1 organization

1 product

2 drugs

1 indication

Organization
Mahidol University
Product
Lidocaine