Intraperitoneal Local Anaesthetic in Colonic Surgery
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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. |
- 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 ]
- 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 |
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| New Zealand | |
| University of Auckland | |
| Auckland, New Zealand | |
| Manukau Surgery Centre-Middlemore Hospital | |
| Auckland, New Zealand, 2240 | |
| 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 May 19, 2013