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

NCT01042054 | Completed

• 2 other identifiers: 09/S1102/172009/R/SU/04
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Keywords

Postoperative Care; Enhanced; Recovery; Hepatectomy; Analgesia

Outcome Measures

Primary Outcomes (1)

• Length of time to reach criteria for discharge from hospital.

  This will be assessed twice daily until criteria for dicharge from hospital are met.

Secondary Outcomes (8)

• Pain scores, assessed using numerical rating score (0 to 10).

  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).

  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).

  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).

  Data collected daily for first 48 hours following operation.

• Mobility (percentage of time spent lying / sitting, standing or walking, as measured by ActivPAL meter).

  From the end of the operative procedure until discharge from hospital, or day 7, whichever is sooner.

Study Arms (2)

Epidural

ACTIVE COMPARATOR

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

Other: Standard optimised recovery protocol.

Wound catheter

EXPERIMENTAL

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.

Interventions

Standard optimised recovery protocol. 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.

Epidural

Wound catheter plus patient-controlled analgesia. 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.

Also known as: ON-Q PainBuster

Wound catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Department of Surgery, Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22882198 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Erica J Revie

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Miss Erica Revie

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 13, 2015

Record last verified: 2015-03

Locations

GB (1)