We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Analgesic Methods, and Their Effects on Patient Recovery, Following Liver Surgery (LIVER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01042054
Recruitment Status : Completed
First Posted : January 5, 2010
Last Update Posted : March 13, 2015
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
Erica Revie, University of Edinburgh

January 4, 2010
January 5, 2010
March 13, 2015
July 2009
July 2010   (Final data collection date for primary outcome measure)
Length of time to reach criteria for discharge from hospital. [ Time Frame: This will be assessed twice daily until criteria for dicharge from hospital are met. ]
Same as current
Complete list of historical versions of study NCT01042054 on ClinicalTrials.gov Archive Site
  • Pain scores, assessed using numerical rating score (0 to 10). [ Time Frame: Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whichever is sooner. ]
  • Nausea and sedation scores, assessed using numerical rating score (0 to 3). [ Time Frame: Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whicever is sooner. ]
  • Sleep disturbance, assessed using numerical rating score (0 to 10). [ Time Frame: Assessed daily from the morning following surgery until discharge from hospital, or day 7, whichever is sooner. ]
  • Volume of intravenous fluids received in the first 48 hours following operation (ml). [ Time Frame: Data collected daily for first 48 hours following operation. ]
  • Mobility (percentage of time spent lying / sitting, standing or walking, as measured by ActivPAL meter). [ Time Frame: From the end of the operative procedure until discharge from hospital, or day 7, whichever is sooner. ]
  • Time to return of bowel function (days). [ Time Frame: Assessed daily until return of bowel function. ]
  • Length of time to meet criteria for discharge from the High Dependency Unit. [ Time Frame: Assessed twice daily until criteria for discharge from the High Dependency Unit met. ]
  • Complications (General and Technical). [ Time Frame: Assessed daily throughout hospital admission, and at outpatient review clinic 4-6 weeks following discharge from hospital. ]
Same as current
Not Provided
Not Provided
 
Comparison of Analgesic Methods, and Their Effects on Patient Recovery, Following Liver Surgery
The Effects of Local Infiltration Versus Epidural on Recovery

The provision of adequate pain relief following major liver surgery is essential, not only for patient comfort, but for the prevention of complications, such as chest infection.

Commonly, pain relief in the first few days after surgery is provided by epidural analgesia. Drugs are delivered to the area around the spinal cord, through a fine plastic tube placed in the patients back, and this blocks sensation from the abdomen downwards, thereby providing effective pain relief without the need for opiate analgesia (e.g. morphine). Opiate analgesia can cause nausea, drowsiness and constipation, and its use should be minimised. Epidurals, however, can be associated with some problematic side effects. Low blood pressure is commonly encountered, and not only can its treatment be associated with complications, but patients are often confined to bed.

Mobility can also be limited if muscle function in the legs, (in addition to sensation), is inadvertently affected by the epidural drugs. Other problems associated with epidural use are the relatively common failure of the technique to provide adequate analgesia (20%), and some extremely rare but potentially disastrous complications of epidural insertion.

An alternative technique, is the provision of pain relief directly into the wound, via one or more multi−holed tubes(catheters), placed either in or close to the wound. This technique alone does not provide as effective analgesia as a functioning epidural, but when combined with other intravenous or oral analgesia, has been shown to be effective following a variety of surgical procedures.

It is hypothesised that, following major liver surgery, the use of this latter technique may result in superior outcome and faster recovery, when compared with epidural, by avoidance of the side effects and complications discussed above.

In this study, patients scheduled to undergo major liver surgery at the Royal Infirmary of Edinburgh with be randomly assigned to receive the first two days of pain relief either by epidural, or by wound catheter plus additional analgesia. Both groups will then receive an identical oral analgesic regime for the remainder of the hospital stay.

Outcomes of interest will include the quality of pain relief attained, patient mobility, frequency of complications, and overall recovery time.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Postoperative Pain
  • Other: Standard optimised recovery protocol.
    • Epidural analgesia for the first 48 hours postoperatively.
    • Sham wound catheter attached to anterior abdominal wall, for purposes of blinding.
    • Standard oral analgesic regime commenced at 48 hours, and continued until discharge from hospital.
    • Optimised recovery protocol followed throughout.
  • Other: Wound catheter plus patient-controlled analgesia.
    • Continuous infusion of local anaesthetic administered via wound catheters for the first 48 hours postoperatively.
    • Additional patient-controlled intravenous opiate analgesia available to patient during this time period.
    • Sham epidural catheter applied to the patient's back for purposes of blinding.
    • Standard oral analgesic regime commenced at 48 hours, and continued until discharge from hospital.
    • Optimised recovery protocol followed throughout.
    Other Name: ON-Q PainBuster
  • Active Comparator: Epidural
    Patients will follow a standard optimised recovery protocol, including epidural analgesia for the first 48 hours postoperatively.
    Intervention: Other: Standard optimised recovery protocol.
  • Experimental: Wound catheter
    Patients will follow a standard optimised recovery protocol, but analgesia in the first 48 hours will be delivered through local anaesthetic wound catheters and additional patient-controlled analgesia, instead of epidural analgesia.
    Intervention: Other: Wound catheter plus patient-controlled analgesia.
Revie EJ, McKeown DW, Wilson JA, Garden OJ, Wigmore SJ. Randomized clinical trial of local infiltration plus patient-controlled opiate analgesia vs. epidural analgesia following liver resection surgery. HPB (Oxford). 2012 Sep;14(9):611-8. doi: 10.1111/j.1477-2574.2012.00490.x. Epub 2012 Jun 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
July 2010
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing open hepatic resection for benign or malignant conditions.
  • Able to understand the nature of the study and what will be required of them.
  • Men and non-pregnant, non-lactating women.
  • BMI 18-40.

Exclusion Criteria:

  • Patients with contraindication to either epidural or wound catheter techniques.
  • Inability to give written, informed consent.
  • Patients with dementia or neurological impairment.
  • Patients with pre-existing condition limiting mobility.
  • Underlying cirrhotic liver disease.
  • Jaundice (Bilirubin > 50 μmol/L).
  • Liver resection combined with secondary surgical procedure.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01042054
09/S1102/17
2009/R/SU/04 ( Other Identifier: South East Scotland Research Ethics Committee 02 )
No
Not Provided
Not Provided
Erica Revie, University of Edinburgh
University of Edinburgh
NHS Lothian
Principal Investigator: Erica J Revie University of Edinburgh
University of Edinburgh
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP