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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Edinburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
NHS Lothian
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01042054
First received: January 4, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Postoperative Pain
Other: Standard optimised recovery protocol.
Other: Wound catheter plus patient-controlled analgesia.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effects of Local Infiltration Versus Epidural on Recovery

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Volume of intravenous fluids received in the first 48 hours following operation (ml). [ Time Frame: Data collected daily for first 48 hours following operation. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Time to return of bowel function (days). [ Time Frame: Assessed daily until return of bowel function. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Complications (General and Technical). [ Time Frame: Assessed daily throughout hospital admission, and at outpatient review clinic 4-6 weeks following discharge from hospital. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: July 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Epidural
Patients will follow a standard optimised recovery protocol, including epidural analgesia for the first 48 hours postoperatively.
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.
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042054

Contacts
Contact: Erica J Revie, BSc MBChB MRCS erica.revie@ed.ac.uk

Locations
United Kingdom
Department of Surgery, Royal Infirmary of Edinburgh Recruiting
Edinburgh, Midlothian, United Kingdom, EH16 4SA
Principal Investigator: Erica J Revie, BSc MBChB MRCS         
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: Erica J Revie University of Edinburgh
  More Information

No publications provided by University of Edinburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Erica Revie, University of Edinburgh
ClinicalTrials.gov Identifier: NCT01042054     History of Changes
Other Study ID Numbers: 09/S1102/17, 2009/R/SU/04
Study First Received: January 4, 2010
Last Updated: January 4, 2010
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Edinburgh:
Postoperative Care
Enhanced
Recovery
Hepatectomy
Analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014