CompletedPhase 4ACTRN12615000554561

Painbuster rectus sheath infusion device for analgesia following laparotomy

Do patients undergoing major abdominal surgery benefit from use of the Painbuster rectus sheath infusion device for improving analgesia or reducing opioid requirement in the post-operative period, a double blinded placebo controlled trial.

Sponsor

Waikato hospital

Enrollment

110 participants

Start Date

Nov 10, 2015

Study Type

Interventional

Conditions

Analgesia Laparotomy

Summary

The study hypothesis is that there is no difference in opioid consumption or pain scores following major abdominal surgery with the use of the painbuster rectus sheath infusion device. To do this, we will compare 3 groups, receiving either normal saline, 0.2% ropivacaine, or 0.5% ropivacaine through the painbuster device. Pain scores and opioid consumption will be recorded for the duration the painbuster infusion (100 hours). The outcome of the study will have important implications for use of these devices in our insitution. If they prove to be beneficial, then the patient experience will be improved. If there is no benefit to them, then the hospital will save money by not purchasing these devices.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria3

Age 18-80
Midline laparotomy
Planned painbuster device as part of analgesic regimen

Exclusion Criteria2

Exclusions would be patient refusal,
plan for epidural analgesia and inability to follow up the patient i.e. not able to communicate for any reason (dementia, not able to speak English) and expected ICU admission following surgery.

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Interventions

IAll patients eliglble for the study will have a painbuster rectus sheath infusion catheter inserted by the surgeon at the end of surgery. This will be initially bolused with 30ml of 0.2% ropivacaine

IAll patients eliglble for the study will have a painbuster rectus sheath infusion catheter inserted by the surgeon at the end of surgery. This will be initially bolused with 30ml of 0.2% ropivacaine in all patients. Patients will then be randomized to have the painbuster elastometric pump either filled with normal saline, 0.2% ropivacaine, or 0.5% ropivacaine, and pain scores, opioid consumption, length of hospital stay, time to first eating and mobilisation and presence of side effects will be recorded. The elastometric pump will contain 400ml of fluid (either normal saline or ropivacaine) and this is infused at 4ml an hour for 100 hours following surgery. There are 2 rectus sheath catheters inserted by the surgeon and each catheter runs at a non-titrable rate of 2ml/hr via the elastometric pump. Compliance to use of the painbuster pump and time at discontinuation will be monitored by the pain team who will be responsible for follow up and data collection for the study patients.