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OpenTrials
Completed

NCT Number: NCT01747122

The Effects of Local Infiltration Versus Epidural Following Liver Resection 2

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

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Key information

Conditions

Open Liver Resection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wound catheter

Device

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

Other names: On-Q Painbuster

Epidural

Device

Primary outcomes

  1. Length of stay

    Time frame: Measurement 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 outcomes

  1. Pain Scores

    Time frame: Performed 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.

  2. Molecular response to surgery

    Time frame: Days 0, 1 and 3

    HMGB1, RAGE and cytokines

  3. Central Venous Pressure

    Time frame: During liver transection

    Mean Central Venous Pressure during liver transection will be quantified and compared between groups.

  4. Estimated Blood Loss

    Time frame: Intra-operative

  5. Operative field asessment

    Time frame: During liver transection

  6. Pringle time

    Time frame: Intra-operative

Other outcomes

  1. Quality of Life (EQ-5D)

    Time frame: Pre-operative, 2 weeks post-operative, 4-6 weeks post-operative

  2. Morphine consumption

    Time frame: Day of surgery and postoperative days 1-7

  3. IV Fluid volume

    Time frame: Day of Surgery and postoperative days 1-7

  4. Complications

    Time frame: day of surgery and post-operative days 1-30

  5. Post-operative blood tests (FBC, U&E, LFTs, coag)

    Time frame: Post-operative days 1-7

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

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.

Acronym: LIVER 2

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2012
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.