Intraperitoneal Local Anaesthetic in Colonic Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Auckland, New Zealand
ClinicalTrials.gov Identifier:
NCT00722709
First received: July 23, 2008
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Colon Surgery
Drug: Ropivacaine
Drug: 0.9% Saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Double Blind Trial to Investigate the Effects of Intraperitoneal Local Anaesthetic Following Colonic Surgery.

Resource links provided by NLM:


Further study details as provided by University of Auckland, New Zealand:

Primary Outcome Measures:
  • Post operative recovery using the Identity consequence fatigue scale (ICFS) [ Time Frame: Base-line, Day 1, Day 3, Day 7, Day 14, Day 30, Day 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-operative rest, movement and cough pain using Visual analogue score [ Time Frame: 2,4,6,8,12,24,48,72 hours and on day 7 ] [ Designated as safety issue: No ]
  • Post operative analgesia use using morphine equivalence data [ Time Frame: Total use on day 1, day 2, day 3 post operatively and total use until discharge ] [ Designated as safety issue: No ]
  • Serum Ropivacaine level, serum Cytokine, serum Cortisol, serum glucose and serum CRP. Albumin, haematological parameters and biochemical parameters. [ Time Frame: Pre-operatively, 8, 20, 48,72 hours post operatively ] [ Designated as safety issue: Yes ]
  • Questions aimed at symptoms of local anaesthetic toxicity [ Time Frame: 2, 4, 6, 8, 12, 24, 48, 72 hours post operatively ] [ Designated as safety issue: Yes ]
  • Recovery of bowel function measured by time to pass flatus and time to pass stool post-operatively. [ Time Frame: Assessed at 2, 4, 6, 8, 12, 24, 36, 48, 60, 72 hours. ] [ Designated as safety issue: No ]
  • Quality of care assessment based on a 100mm visual analogue scale (1-10). [ Time Frame: pre-op, day1, day 2, day3, day 7, day 30 and day 60 post operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2008
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LA
Use of Ropivacaine
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.

Placebo Comparator: Placebo
Use of 0.9% saline
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive patients undergoing open colonic resection at MSC under the ERAS program.

Exclusion Criteria:

  • Known sensitivity to the local anaesthetic agents
  • Patients who prefer not to participate (no consent gained)
  • ASA greater or equal to 4
  • Rectal resection
  • Formation of stoma
  • Current use of systemic steroids
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722709

Locations
New Zealand
University of Auckland
Auckland, New Zealand
Manukau Surgery Centre-Middlemore Hospital
Auckland, New Zealand, 2240
Sponsors and Collaborators
University of Auckland, New Zealand
Investigators
Study Director: Arman A Kahokehr, MBChB University of Auckland, New Zealand
Principal Investigator: Andrew G Hill, FRACS University of Auckland, New Zealand
  More Information

No publications provided by University of Auckland, New Zealand

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Arman Kahokehr, University of Auckland
ClinicalTrials.gov Identifier: NCT00722709     History of Changes
Other Study ID Numbers: LAstudy
Study First Received: July 23, 2008
Last Updated: January 12, 2010
Health Authority: New Zealand: Health Research Council

Keywords provided by University of Auckland, New Zealand:
Pain
Fatigue
Colon
Surgery
ERAS
Fastrack
Local anaesthetic
Peritoneum
Metabolic
Endocrine
Post surgical metabolic response
Complications
Time to passage of flatus
Time to passage of stool
Time to discharge from facility
Re-admission rate

Additional relevant MeSH terms:
Anesthetics, Local
Ropivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014