Retrospective

Simon Chan

email simonkcchan@cuhk.edu.hk

Simon Chan

email simonkcchan@cuhk.edu.hk

Yes

2005-08-08

Drug

Ropivacaine wound instillation in patients undergone elective hepatic resection surgery

68 hours

Compared with placebo

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, a) she must has been using effective contraception and would continue to use effective contraception during the study period, b) is not lactating and, c) 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.

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.

Randomized

Placebo

Double-blind

Parallel

No