Efficacy of Multimodal Opioid Therapy During Hepatic Resection Surgery
RITM-IVM
Efficacy Of IV Morphine vs Remifentanil-Intrathecal Morphine Analgesia During Hepatic Resection Surgery
1 other identifier
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 2, 2007
CompletedFirst Posted
Study publicly available on registry
November 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedDecember 31, 2008
December 1, 2008
8 months
November 2, 2007
December 30, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Opioid-related side effects
First 24 hours post-operatively
Secondary Outcomes (1)
IV opioid analgesic supplementation
First 24 hours post-operatively
Study Arms (2)
1
ACTIVE COMPARATORIV morphine group
2
EXPERIMENTALRemifentanil-intrathecal morphine group
Interventions
Intravenous morphine titrated up to 0.25 milligrams/kilogram prior to end of resection phase or within first 2 hours of surgery
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
Eligibility Criteria
You may qualify if:
- Adult
- ASA I, II or stable III
- Undergoing primary elective hepatic resection of \< 50% predicted parenchymal resection
You may not qualify if:
- 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)
- sleep apnoea
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Vincent's University Hospital
Dublin, County Dublin, 4, Ireland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neil J. McDonald, MB BCh
St Vincent's University Hospital, Ireland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 2, 2007
First Posted
November 5, 2007
Study Start
September 1, 2007
Primary Completion
May 1, 2008
Study Completion
June 1, 2008
Last Updated
December 31, 2008
Record last verified: 2008-12