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

NCT ID: NCT01042054

Last Updated: 2015-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-07-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Epidural

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

Group Type: ACTIVE_COMPARATOR

Standard optimised recovery protocol.

Intervention Type: OTHER

• 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.

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.

Group Type: EXPERIMENTAL

Wound catheter plus patient-controlled analgesia.

Intervention Type: OTHER

• 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

ON-Q PainBuster

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Erica Revie

Miss Erica Revie

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erica J Revie

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

Department of Surgery, Royal Infirmary of Edinburgh

Edinburgh, Midlothian, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 22882198 (View on PubMed)

Other Identifiers

2009/R/SU/04

Identifier Type: OTHER

Identifier Source: secondary_id

09/S1102/17

Identifier Type: -

Identifier Source: org_study_id