Efficacy of Multimodal Opioid Therapy During Hepatic Resection Surgery (RITM-IVM)
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|ClinicalTrials.gov Identifier: NCT00553553|
Recruitment Status : Unknown
Verified December 2008 by St Vincent's University Hospital, Ireland.
Recruitment status was: Recruiting
First Posted : November 5, 2007
Last Update Posted : December 31, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Dysfunction Pain||Drug: Morphine sulphate Drug: Morphine hydrochloride, remifentanil hydrochloride||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy Of IV Morphine vs Remifentanil-Intrathecal Morphine Analgesia During Hepatic Resection Surgery|
|Study Start Date :||September 2007|
|Estimated Primary Completion Date :||May 2008|
|Estimated Study Completion Date :||June 2008|
Active Comparator: 1
IV morphine group
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
Remifentanil-intrathecal morphine group
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
- Opioid-related side effects [ Time Frame: First 24 hours post-operatively ]
- IV opioid analgesic supplementation [ Time Frame: First 24 hours post-operatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553553
|Contact: Debbie A. D'Oyley, MB BS||+3531 email@example.com|
|Contact: Neil J. McDonald, MB BCh||+3531 firstname.lastname@example.org|
|St. Vincent's University Hospital||Recruiting|
|Dublin, County Dublin, Ireland, 4|
|Principal Investigator: Neil J. McDonald, MB BCh|
|Principal Investigator:||Neil J. McDonald, MB BCh||St Vincent's University Hospital, Ireland|