Improving Pain Relief Following Laparoscopic Ventral Hernia Repair

NCT02785276 | Withdrawn

• 1 other identifier: COLVHR
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Morphine equivalent use

  Total opiate analgesia (all routes) used from immediately post-operative (0h) during the post-operative recovery period up to 24 hours will be recorded and converted into morphine equivalents.

  Total opiate consumption in the first 24 hours

Secondary Outcomes (1)

• Post-operative pain scores

  Until day 7 post-operatively

Other Outcomes (1)

• Complications

  From immediately post-operative up until 30 days following laparoscopic ventral hernia repair

Study Arms (2)

Ropivacaine infusion

EXPERIMENTAL

Following the insertion of the 2mm fenestrated catheter, the wound catheter will be connected to the 270mL AutoFuser Pain Pump. The intraperitoneal infusion with ropivacaine (0.2%) at 4 mL/hour will start immediately and continue for 68 hours post-operatively uninterrupted.

Device: AutoFuser Pain Pump; Drug: Ropivacaine

Placebo infusion

PLACEBO COMPARATOR

In the same manner as described for the ropivacaine infusion arm, 0.9% Normal Saline will be administered over 68 hours.

Device: AutoFuser Pain Pump; Other: Normal Saline (0.9%)

Interventions

AutoFuser Pain Pump DEVICE

Closed loop local anaesthetic infusion system

Placebo infusion; Ropivacaine infusion

Ropivacaine DRUG

Commonly used local anaesthetic drug

Also known as: Naropin (0.2%)

Ropivacaine infusion

Normal Saline (0.9%) OTHER

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.

Also known as: Sodium chloride (NaCl)

Placebo infusion

Eligibility Criteria

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

You may not qualify if:

• acute presentation, open repair of ventral hernia, hepatic dysfunction ALT/AST ≥ 2 x ULN, previous adverse reaction/allergy to ropivacaine, opiate use greater than 6 months, patients with a diagnosis of Chronic Pain Syndrome (CPS), patients under 16 years of age, patient refusal and those without the ability to consent

Sponsors & Collaborators

• University of Auckland, New Zealand: lead

Study Sites (1)

Manukau Surgical Centre, Middlemore Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Ventral

Interventions

Ropivacaine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Andrew G Hill, MD, EdD, FACS, FRACS

  The University of Auckland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 27, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2018
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)