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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00722709




Registration number
NCT00722709
Ethics application status
Date submitted
23/07/2008
Date registered
25/07/2008
Date last updated
13/01/2010

Titles & IDs
Public title
Intraperitoneal Local Anaesthetic in Colonic Surgery
Scientific title
Randomised Double Blind Trial to Investigate the Effects of Intraperitoneal Local Anaesthetic Following Colonic Surgery.
Secondary ID [1] 0 0
LAstudy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon Surgery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ropivacaine
Treatment: Drugs - 0.9% Saline

Experimental: LA - Use of Ropivacaine

Placebo Comparator: Placebo - Use of 0.9% saline


Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Post operative recovery using the Identity consequence fatigue scale (ICFS)
Timepoint [1] 0 0
Base-line, Day 1, Day 3, Day 7, Day 14, Day 30, Day 60
Secondary outcome [1] 0 0
Post-operative rest, movement and cough pain using Visual analogue score
Timepoint [1] 0 0
2,4,6,8,12,24,48,72 hours and on day 7
Secondary outcome [2] 0 0
Post operative analgesia use using morphine equivalence data
Timepoint [2] 0 0
Total use on day 1, day 2, day 3 post operatively and total use until discharge
Secondary outcome [3] 0 0
Serum Ropivacaine level, serum Cytokine, serum Cortisol, serum glucose and serum CRP. Albumin, haematological parameters and biochemical parameters.
Timepoint [3] 0 0
Pre-operatively, 8, 20, 48,72 hours post operatively
Secondary outcome [4] 0 0
Questions aimed at symptoms of local anaesthetic toxicity
Timepoint [4] 0 0
2, 4, 6, 8, 12, 24, 48, 72 hours post operatively
Secondary outcome [5] 0 0
Recovery of bowel function measured by time to pass flatus and time to pass stool post-operatively.
Timepoint [5] 0 0
Assessed at 2, 4, 6, 8, 12, 24, 36, 48, 60, 72 hours.
Secondary outcome [6] 0 0
Quality of care assessment based on a 100mm visual analogue scale (1-10).
Timepoint [6] 0 0
pre-op, day1, day 2, day3, day 7, day 30 and day 60 post operatively

Eligibility
Key inclusion criteria
- Consecutive patients undergoing open colonic resection at MSC under the ERAS program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2010
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00722709
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Arman A Kahokehr, MBChB
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00722709