Comparison of Analgesic Methods, and Their Effects on Patient Recovery, Following Liver Surgery (LIVER)
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|ClinicalTrials.gov Identifier: NCT01042054|
Recruitment Status : Completed
First Posted : January 5, 2010
Last Update Posted : March 13, 2015
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 or disease||Intervention/treatment||Phase|
|Postoperative Pain||Other: Standard optimised recovery protocol. Other: Wound catheter plus patient-controlled analgesia.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effects of Local Infiltration Versus Epidural on Recovery|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
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.
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.
Other Name: ON-Q PainBuster
- 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. ]
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042054
|Department of Surgery, Royal Infirmary of Edinburgh|
|Edinburgh, Midlothian, United Kingdom, EH16 4SA|
|Principal Investigator:||Erica J Revie||University of Edinburgh|