Pain control after elective liver resection surgery
Conditions
Interventions
1:Ropivacaine wound instillation in patients undergone elective hepatic resection surgery for 68 hours
2:Placebo
Sponsors
Department of Anaesthesia and Intensive Care, CUHK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To qualify for admission to this study, a patient must satisfy the criteria listed below: 1. The patient must be at least 18 years old and of legal age of consent; 2. If the patient is a female of childbearing potential: (1) she must has been using effective contraception and would continue to use effective contraception during the study period; (2) is not lactating and (3) must has a negative urine pregnancy test within 7 days prior to the surgery. 3. The patient is in satisfactory health as determined by the investigator on the basis of medical history and physical examination; 4. The patient is undergoing elective hepatic resection surgery and is expected to experience post-surgical pain in the absence of post-operative analgesia; 5. The patient has given written informed consent prior to undergoing any procedures for the study.
Exclusion criteria
Exclusion criteria: A patient will be excluded from this study if he/she meets any of the criteria listed below: 1. The patient is undergoing an emergency hepatic resection surgery; 2. The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness, which in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results; 3. The patient has any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures; 4. The patient's age is 70 or above; 5. The patient has a history of alcohol, analgesic or narcotic abuse; 6. The patient is unable to use PCA; 7. The patient has a known hypersensitivity to local anaesthetic drugs; 8. The patient is considered to have clinically significant intravascular volume-depletion in the opinion of the investigator; 9. The patient has history of opioid intolerance; 10. The patient has received any investigational medication within 30 days prior to administration of study medication or is scheduled to receive an investigational drug other than ropivacaine during the course of this study; 11. The patient develops major intra-operative complications, such as major haemorrhage or haemodynamic instability, which in the opinion of the investigator, would contraindicate study participation; 12. The patient has been admitted to this study previously.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the analgesic efficacy of ropivacaine wound instillation versus placebo for elective liver resection surgery.; | — |
Secondary
| Measure | Time frame |
|---|---|
| To examine the pharmacokinetic profiles of ropivacaine continuous wound instillation in post-hepatectomized patients.; | — |
Countries
China
Contacts
Public ContactSimon Chan
Outcome results
None listed