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The Effects of Local Infiltration Versus Epidural Following Liver Resection 2

A Randomised Trial of Peri-operative Nerve Block and Continuous Infusion of Local Anaesthetic Via Wound Catheter Versus Epidural in Patients Undergoing Open Liver Resection.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01747122
Acronym
LIVER 2
Enrollment
97
Registered
2012-12-11
Start date
2012-12-31
Completion date
2014-08-31
Last updated
2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Liver Resection

Keywords

epidurals, wound catheters, liver resection, liver surgery

Brief summary

The investigators plan to compare epidurals versus wound catheters for effects on pain relief and recovery following open liver surgery.

Interventions

Wound catheter, placed at end of procedure, prior to closure. To be kept in for 48 hours.

DEVICEEpidural

Sponsors

NHS Lothian
CollaboratorOTHER_GOV
University of Edinburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing open hepatic resection for benign or malignant conditions.

Exclusion criteria

* Patients with contraindication to either epidural or wound catheter techniques. * Inability to give written, informed consent. * Jaundice (Bilirubin \> 100 μmol/L) * Liver resection combined with secondary surgical procedure. * Age \< 18 years * Pregnant women * patients on long term opiates for chronic pain

Design outcomes

Primary

MeasureTime frameDescription
Length of stayMeasurement made on day of discharge which is expected to be on average bewteen 5 and 10 days after surgery.Number of days (to nearest half day) patients stay in hospital.

Secondary

MeasureTime frameDescription
Molecular response to surgeryDays 0, 1 and 3HMGB1, RAGE and cytokines
Pain ScoresPerformed daily at 0900 hours. On the day of surgery pain scores will be performed at 2, 6 and 12 hours post surgery.Visual analogue scores of pain experienced.
Central Venous PressureDuring liver transectionMean Central Venous Pressure during liver transection will be quantified and compared between groups.
Estimated Blood LossIntra-operative
Operative field asessmentDuring liver transection
Pringle timeIntra-operative

Other

MeasureTime frame
IV Fluid volumeDay of Surgery and postoperative days 1-7
Complicationsday of surgery and post-operative days 1-30
Post-operative blood tests (FBC, U&E, LFTs, coag)Post-operative days 1-7
Morphine consumptionDay of surgery and postoperative days 1-7
Quality of Life (EQ-5D)Pre-operative, 2 weeks post-operative, 4-6 weeks post-operative

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026