Efficacy of Multimodal Opioid Therapy During Hepatic Resection Surgery
NCT00553553 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2008-12-31
Summary
The patient population requiring hepatic resection can demonstrate an unpredictable risk of exhibiting peri-operative coagulopathy resulting either from the pre-operative hepatic pathophysiology or volume of parenchymal resection. Choice of analgesia can be severely limited.
Currently, the most commonly described use of combined remifentanil infusion and intrathecal morphine has been in fast-track cardiac surgery. To date, there are no published data describing its use in the context of major hepatobiliary where the investigators predict it may provide adequate analgesia with a lower rate of adverse effects over the first 24 hours after surgery.
Conditions
- Liver Dysfunction
- Pain
Interventions
- DRUG
-
Morphine sulphate
Intravenous morphine titrated up to 0.25 milligrams/kilogram prior to end of resection phase or within first 2 hours of surgery
- DRUG
-
Morphine hydrochloride, remifentanil hydrochloride
Pre-induction intrathecal morphine HCl (\< 3 attempts), single shot via 25 G pencil point spinal needle at 10 micrograms/kilogram Intra-operative intravenous remifentanil HCl at titratable dose range 0.1-0.25 micrograms/kilogram/minute until start of wound closure
Sponsors & Collaborators
-
St Vincent's University Hospital, Ireland
lead OTHER
Principal Investigators
-
Neil J. McDonald, MB BCh · St Vincent's University Hospital, Ireland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-09-30
- Primary Completion
- 2008-05-31
- Completion
- 2008-06-30
Countries
- Ireland
Study Locations
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