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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000554561
Enrollment
110
Registered
2015-05-29
Start date
2015-11-10
Completion date
2017-10-23
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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 b

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.

Sponsors

Waikato hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026