Intraperitoneal Local Anaesthetic in Colonic Surgery

Summary

Aim:

The general aim of this research group is to improve the recovery of patients after abdominal surgery. The specific aim of this study is to conduct a randomized, double blinded, controlled trial to investigate the effect of intra-peritoneal local anaesthesia application on postoperative pain and post-operative fatigue. This will be conducted in the setting of an enhanced recovery after surgery program (ERAS).

Methods:

Patients will be randomised by computer generated random numbers and opaque envelope method. In the treatment arm patients will receive 10ml 0.75% ropivacaine diluted to 50mls with 0.9% saline soon after the creation of the laparotomy . In the placebo arm, 50mls of 0.9% normal saline will be used in a similar fashion. At closure, two small 2mm catheter belonging to the On-Q pain buster system will be placed in the peritoneal cavity. This will be attached to a pump which will contain either a 0.2% ropivacaine solution or 0.9% saline placebo running at 4mls/hr for 68 hours. All members involved in patient care (with the exception of one nurse) will be blinded to the above. After 68 hours the pump will be stopped and the catheter will be removed. Assessment of postoperative pain will be performed by visual analogue scale, and fatigue assessment will be done using the Identity Consequence Fatigue Scale (ICFS) at various intervals post-operatively. Blood tests for inflammatory markers including glucose, cortisol, CRP, albumin and several cytokines as well as local anaesthetic levels will be taken.

Significance to health:

This method of analgesia administration has not been investigated in open major colonic surgery. This trial has wide reaching implications, with the potential to improve pain and thus recovery after abdominal surgery.

Conditions

• Colon Surgery

Interventions

DRUG

Ropivacaine

In the treatment arm patients will receive 10mls 0.75% ropivacaine diluted to 50mls with saline immediately before closure. At closure, two small 2 mm catheters will be placed in the peritoneal cavity at the site of the operation to infuse local anaesthesia. This will penetrate through the skin once closure is complete. This will be attached to a small infusion pump (On-Q pain buster). This pump will contain 270mls of 0.2% ropivacaine. After 68 hours the pump will be stopped and the catheter will be removed in a similar fashion as routine drain removal.

DRUG

0.9% Saline

In the placebo arm patients will receive 50 ml 0.9% saline into the peritoneum soon after the creation of the laparotomy. At closure, two 2 mm catheters will be placed in the peritoneal cavity at the site of the operation to infuse local anaesthesia. This will penetrate through the skin once closure is complete. This will be attached to a small infusion pump on-Q pain buster). This pump will contain 0.9% saline. After 68 hours the pump will be stopped and the catheter will be removed in a similar fashion as routine drain removal.

Sponsors & Collaborators

• University of Auckland, New Zealand

  lead OTHER

Principal Investigators

• Arman A Kahokehr, MBChB · University of Auckland, New Zealand

• Andrew G Hill, FRACS · University of Auckland, New Zealand

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2009-11-30

Completion

2010-01-31

Countries

• New Zealand

Study Locations