Efficacy of Multimodal Opioid Therapy During Hepatic Resection Surgery
Information source: St Vincent's University Hospital, Ireland
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Dysfunction; Pain
Intervention: Morphine sulphate (Drug); Morphine hydrochloride, remifentanil hydrochloride (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: St Vincent's University Hospital, Ireland Official(s) and/or principal investigator(s):
Neil J. McDonald, MB BCh, Principal Investigator, Affiliation: St Vincent's University Hospital, Ireland
Overall contact:
Debbie A. D'Oyley, MB BS, Phone: +3531 2094262, Email: doyleyda@aol.com
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.
Clinical Details
Official title: Efficacy Of IV Morphine vs Remifentanil-Intrathecal Morphine Analgesia During Hepatic Resection Surgery
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Opioid-related side effects
Secondary outcome: IV opioid analgesic supplementation
Detailed description:
Choice of analgesia in hepatic resection surgery can be severely limited. This can depend
upon on the pre-operative hepatic pathophysiology or the extent of parenchymal resection,
both of which will affect peri-operative hepatic function, capacity for drug handling and
risk of coagulopathy. Use of IV morphine during hepatic resection can result in high plasma
levels post-operatively due to a reduced rate of morphine metabolism, risking a higher rate
of morbidity. However, this remains a mainstay of peri-operative analgesia in combination
with controversial non-opioid supplementation (paracetamol, non-steroidal anti-inflammatory
drugs).
This study compares the efficacy of IV morphine only versus a combination of pre-incisional
intrathecal morphine and intra-operative IV remifentanil. Intrathecal morphine provides the
mainstay of post-operative analgesia for 12-24 hours and remifentanil provides profound,
titratable intra-operative analgesia until the delayed onset of the intrathecal morphine. We
hypothesise that this combination might provide desirable intra-operative haemodynamic
conditions and eliminate the post-operative additive effects of long-acting, intra-operative
IV opioid and intrathecal morphine. Further, if the dose of intrathecal morphine is
adequate, this would result in a low rate of post-operative analgesic supplementation and
fewer side effects. The titratable dose range of remifentanil is limited to the lower range
found to risk post-operative hyperalgesia.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult
- ASA I, II or stable III
- Undergoing primary elective hepatic resection of < 50% predicted parenchymal
resection
Exclusion Criteria:
- Previous major upper GI surgery:
- liver resection or transplant
- gastrectomy
- oesophagectomy
- Whipple's procedure
- Contraindications to dural puncture:
- coagulopathy
- uncorrected anti-coagulant therapy
- spinal deformity
- neurological disorder
- psychiatric disorder
- Morphine allergy
- Co-morbidity predisposing to failure of extubation at conclusion of surgery:
- severe cardiopulmonary pathology scoring ASA III (unstable)
- IV
- V
- sleep apnoea
- morbid obesity (BMI > 35)
- Failure to proceed with resection, emergency resection or conversion to > 50%
parenchymal resection
- Chronic/intractable pain conditions:
- requiring long-term high dose analgesia
- implanted analgesic devices
- Predisposition to severe post-operative nausea and vomiting:
- motion sickness
- previous PONV
- Anatomical or physiological indication for rapid sequence induction (relative)
Locations and Contacts
Debbie A. D'Oyley, MB BS, Phone: +3531 2094262, Email: doyleyda@aol.com
St. Vincent's University Hospital, Dublin, County Dublin 4, Ireland; Recruiting
Neil J. McDonald, MB BCh, Principal Investigator
Additional Information
Starting date: September 2007
Ending date: June 2008
Last updated: December 30, 2008
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