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Postoperative Pain | Comparison of Analgesic Methods, and Their Effects on Patient Recovery, Following Liver Surgery

Postoperative Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Postoperative Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

EpiduralPatients will follow a standard optimised recovery protocol, including epidural analgesia for the first 48 hours postoperatively.

Wound catheterPatients 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.

Study Status

Completed

Start Date: July 2009

Completed Date: July 2010

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Length of time to reach criteria for discharge from hospital.

Secondary Outcome: Pain scores, assessed using numerical rating score (0 to 10).

Study sponsors, principal investigator, and references

Principal Investigator: Erica J Revie

Lead Sponsor: University of Edinburgh

Collaborator: NHS Lothian

More information:https://clinicaltrials.gov/show/NCT01042054

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