Improving Pain Relief Following Laparoscopic Ventral Hernia Repair

Summary

Aim

The general aim of this study is to improve post-operative pain and reduce morphine consumption following laparoscopic ventral hernia repair (LVHR). We specifically aim to conduct a randomized, double blinded, controlled trial to investigate the effect of intra-peritoneal local anaesthesia infusions on post-operative morphine consumption and.

Methods:

Patients will be randomised by computer generated random numbers (random permutation) and opaque envelope methods. At closure, one small 2mm catheter belonging to the AutoFuser pain pump system will be placed in the peritoneal cavity between the onlay mesh and parietal peritoneum. In the treatment arm patients will receive 275mL of 0.2% ropivacaine at 4mL/h. In the placebo arm, 275mL of 0.9% normal saline will be used in a similar fashion. The infusions will run for 68 hours total. All members involved in patient care (with the exception of one independant research fellow) will be blinded to the above. After 68 hours the pump will be stopped and the catheter will be removed. Assessment of post-operative pain will be performed by visual analogue scale, and total opiate consumption will be collected and converted into morphine equivalents.

Health significance:

Local anaesthesia has become an important addition to multimodal regimens of analgesia following surgery. Recent studies have shown that local anaesthetic (LA) wound infiltration has improved post-operative pain when compared with standard opioid regimens for pain relief. Only one previous study looked at bupivacaine infusions into the hernia sac for three days following LVHR. This study found no improvement in post-operative pain or morphine consumption. We aim to demonstrate improved pain and reduced morphine consumption using an alternative catheter insertion technique and ropivacaine as the desired LA agent.

Conditions

• Pain, Postoperative
• Anesthesia, Local
• Hernia, Ventral
• Laparoscopy
• Analgesics, Opioid
• Complications

Interventions

DEVICE

AutoFuser Pain Pump

Closed loop local anaesthetic infusion system

DRUG

Ropivacaine

Commonly used local anaesthetic drug

OTHER

Normal Saline (0.9%)

Normal saline is a sterile, non-pyrogenic solution for fluid and electrolyte replenishment for intravenous administration. This will be the solution used for the intraperitoneal infusion in the placebo/control group.

Sponsors & Collaborators

• University of Auckland, New Zealand

  lead OTHER

Principal Investigators

• Andrew G Hill, MD, EdD, FACS, FRACS · The University of Auckland

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2017-08-31

Completion

2018-08-31

Countries

• New Zealand

Study Locations