Clinical trial NCT01042054: Comparison of Analgesic Methods, and Their Effects on Patient Recovery, Following Liver Surgery
Official title: The Effects of Local Infiltration Versus Epidural on Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative Care
Enhanced
Recovery
Hepatectomy
Analgesia
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2010-01-05
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Length of time to reach criteria for discharge from hospital.
timeFrame: This will be assessed twice daily until criteria for dicharge from hospital are met.
Secondary outcomes:
measure: Pain scores, assessed using numerical rating score (0 to 10).
timeFrame: Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whichever is sooner.
measure: Nausea and sedation scores, assessed using numerical rating score (0 to 3).
timeFrame: Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whicever is sooner.
measure: Sleep disturbance, assessed using numerical rating score (0 to 10).
timeFrame: Assessed daily from the morning following surgery until discharge from hospital, or day 7, whichever is sooner.
measure: Volume of intravenous fluids received in the first 48 hours following operation (ml).
timeFrame: Data collected daily for first 48 hours following operation.
measure: Mobility (percentage of time spent lying / sitting, standing or walking, as measured by ActivPAL meter).
timeFrame: From the end of the operative procedure until discharge from hospital, or day 7, whichever is sooner.
measure: Time to return of bowel function (days).
timeFrame: Assessed daily until return of bowel function.
measure: Length of time to meet criteria for discharge from the High Dependency Unit.
timeFrame: Assessed twice daily until criteria for discharge from the High Dependency Unit met.
measure: Complications (General and Technical).
timeFrame: Assessed daily throughout hospital admission, and at outpatient review clinic 4-6 weeks following discharge from hospital.
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Department of Surgery, Royal Infirmary of Edinburgh
state: Midlothian
Study officials:
affiliation: University of Edinburgh
name: Erica J Revie
role: PRINCIPAL_INVESTIGATOR
References:
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.