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Efficacy of Multimodal Opioid Therapy During Hepatic Resection Surgery (RITM-IVM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by St Vincent's University Hospital, Ireland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St Vincent's University Hospital, Ireland
ClinicalTrials.gov Identifier:
NCT00553553
First received: November 2, 2007
Last updated: December 30, 2008
Last verified: December 2008
  Purpose

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 Intervention
Liver Dysfunction
Pain
Drug: Morphine sulphate
Drug: Morphine hydrochloride, remifentanil hydrochloride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Of IV Morphine vs Remifentanil-Intrathecal Morphine Analgesia During Hepatic Resection Surgery

Resource links provided by NLM:


Further study details as provided by St Vincent's University Hospital, Ireland:

Primary Outcome Measures:
  • Opioid-related side effects [ Time Frame: First 24 hours post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IV opioid analgesic supplementation [ Time Frame: First 24 hours post-operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: September 2007
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: 2
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


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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553553

Contacts
Contact: Debbie A. D'Oyley, MB BS +3531 2094262 doyleyda@aol.com
Contact: Neil J. McDonald, MB BCh +3531 2094262 n.mcdonald@svuh.ie

Locations
Ireland
St. Vincent's University Hospital Recruiting
Dublin, County Dublin, Ireland, 4
Principal Investigator: Neil J. McDonald, MB BCh         
Sponsors and Collaborators
St Vincent's University Hospital, Ireland
Investigators
Principal Investigator: Neil J. McDonald, MB BCh St Vincent's University Hospital, Ireland
  More Information

No publications provided

Responsible Party: Dr. N. J. McDonald, St. Vincent's University Hospital, Dublin
ClinicalTrials.gov Identifier: NCT00553553     History of Changes
Other Study ID Numbers: St. Vincent's Hospital Ireland
Study First Received: November 2, 2007
Last Updated: December 30, 2008
Health Authority: Ireland: Ministry of Health

Keywords provided by St Vincent's University Hospital, Ireland:
Intrathecal morphine ITM intravenous morphine remifentanil hepatic resection
Adult
ASA I-III (stable)
Liver dysfunction requiring primary parenchymal resection

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Morphine
Remifentanil
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014