Liver DysfunctionRITM-IVMNCT00553553
Efficacy of Multimodal Opioid Therapy During Hepatic Resection Surgery
A study testing Morphine sulphate and Morphine hydrochloride, remifentanil hydrochloride in people with Liver Dysfunction and Pain, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Dysfunction, Pain
- What is being tested?
- Morphine sulphate and Morphine hydrochloride, remifentanil hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIreland
- Study dates
- Sep 2007to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- ASA I, II or stable III
- Undergoing primary elective hepatic resection of < 50% predicted parenchymal resection
Who cannot join
- Previous major upper GI surgery:
- liver resection or transplant
- gastrectomy
- oesophagectomy
- Whipple's procedure
- Contraindications to dural puncture:
Show all 26Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
St. Vincent's University Hospital
Dublin, County Dublin, 4
Neil J. McDonald, MB BCh
About this study
Official title: Efficacy Of IV Morphine vs Remifentanil-Intrathecal Morphine Analgesia During Hepatic Resection Surgery
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.
Read the 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.
- Conditions
- Liver Dysfunction, Pain
- Being tested
- Morphine sulphate, Morphine hydrochloride, remifentanil hydrochloride
- Keywords
- Intrathecal morphine ITM intravenous morphine remifentanil hepatic resection, Adult, ASA I-III (stable), Liver dysfunction requiring primary parenchymal resection
- Medical subject headings
- Liver Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine sulphateDrug
Intravenous morphine titrated up to 0.25 milligrams/kilogram prior to end of resection phase or within first 2 hours of surgery
Morphine hydrochloride, remifentanil hydrochlorideDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | IV morphine group Receives: Drug: Morphine sulphate |
| 2 | Experimental | Remifentanil-intrathecal morphine group Receives: Drug: Morphine hydrochloride, remifentanil hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid-related side effects
Measured: First 24 hours post-operatively
Secondary outcomes (1)
IV opioid analgesic supplementation
Measured: First 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionMay 2008 (estimated)
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's University Hospital, Ireland
- Sponsor type
- University, hospital or other
- Investigators
- Neil J. McDonald, MB BCh, Principal investigator, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553553
- Sponsor's protocol ID
- St. Vincent's Hospital Ireland
- Acronym
- RITM-IVM
- Status last verified
- Dec 2008
- First submitted
- 2 Nov 2007
- Last updated
- 31 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of IV Morphine vs Remifentanil-Intrathecal Morphine Analgesia During Hepatic Resection Surgery
- ClinicalTrials.gov ID
- NCT00553553
- Acronym / sponsor ID
- RITM-IVM / St. Vincent's Hospital Ireland
- Conditions
- Liver Dysfunction, Pain
- Keywords
- Intrathecal morphine ITM intravenous morphine remifentanil hepatic resection, Adult, ASA I-III (stable), Liver dysfunction requiring primary parenchymal resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- St Vincent's University Hospital, IrelandUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- May 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 5 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Morphine sulphateIV morphine group |
| 2 | Experimental | Drug: Morphine hydrochloride, remifentanil hydrochlorideRemifentanil-intrathecal morphine group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult
- ASA I, II or stable III
- Undergoing primary elective hepatic resection of < 50% predicted parenchymal resection
Key exclusion criteria (26 listed)
- Previous major upper GI surgery:
- Contraindications to dural puncture:
- Morphine allergy
- Co-morbidity predisposing to failure of extubation at conclusion of surgery:
- Failure to proceed with resection, emergency resection or conversion to > 50% parenchymal resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine sulphateIntravenous morphine titrated up to 0.25 milligrams/kilogram prior to end of resection phase or within first 2 hours of surgery | Drug | 1 |
| Morphine hydrochloride, remifentanil hydrochloridePre-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 | Drug | 2 |
Primary outcome
Opioid-related side effects
Time frame: First 24 hours post-operatively
1 secondary outcome
IV opioid analgesic supplementation
Time frame: First 24 hours post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil J. McDonald, MB BCh principal investigator
St Vincent's University Hospital, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine sulphate and Morphine hydrochloride, remifentanil hydrochloride in people with Liver Dysfunction and Pain, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Debbie A. D'Oyley, MB BS (+3531 2094262, doyleyda@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid-related side effects (time frame: First 24 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2008.