Comparison of Analgesic Methods, and Their Effects on Patient Recovery, Following Liver Surgery (LIVER)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Standard optimised recovery protocol.
Wound catheter plus patient-controlled analgesia.
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative Care, Enhanced, Recovery, Hepatectomy, Analgesia
Eligibility 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.
Sites / Locations
- Department of Surgery, Royal Infirmary of Edinburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Epidural
Wound catheter
Arm Description
Patients will follow a standard optimised recovery protocol, including epidural analgesia for the first 48 hours postoperatively.
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.
Outcomes
Primary Outcome Measures
Length of time to reach criteria for discharge from hospital.
Secondary Outcome Measures
Pain scores, assessed using numerical rating score (0 to 10).
Nausea and sedation scores, assessed using numerical rating score (0 to 3).
Sleep disturbance, assessed using numerical rating score (0 to 10).
Volume of intravenous fluids received in the first 48 hours following operation (ml).
Mobility (percentage of time spent lying / sitting, standing or walking, as measured by ActivPAL meter).
Time to return of bowel function (days).
Length of time to meet criteria for discharge from the High Dependency Unit.
Complications (General and Technical).
Full Information
NCT ID
NCT01042054
First Posted
January 4, 2010
Last Updated
March 12, 2015
Sponsor
University of Edinburgh
Collaborators
NHS Lothian
1. Study Identification
Unique Protocol Identification Number
NCT01042054
Brief Title
Comparison of Analgesic Methods, and Their Effects on Patient Recovery, Following Liver Surgery
Acronym
LIVER
Official Title
The Effects of Local Infiltration Versus Epidural on Recovery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative Care, Enhanced, Recovery, Hepatectomy, Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epidural
Arm Type
Active Comparator
Arm Description
Patients will follow a standard optimised recovery protocol, including epidural analgesia for the first 48 hours postoperatively.
Arm Title
Wound catheter
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Standard optimised recovery protocol.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Wound catheter plus patient-controlled analgesia.
Other Intervention Name(s)
ON-Q PainBuster
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
Volume of intravenous fluids received in the first 48 hours following operation (ml).
Time Frame
Data collected daily for first 48 hours following operation.
Title
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.
Title
Time to return of bowel function (days).
Time Frame
Assessed daily until return of bowel function.
Title
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.
Title
Complications (General and Technical).
Time Frame
Assessed daily throughout hospital admission, and at outpatient review clinic 4-6 weeks following discharge from hospital.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica J Revie
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
22882198
Citation
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.
Results Reference
derived
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Comparison of Analgesic Methods, and Their Effects on Patient Recovery, Following Liver Surgery
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