Efficacy of Multimodal Opioid Therapy During Hepatic Resection Surgery

NCT00553553 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2008-12-31

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00553553 on ClinicalTrials.gov