Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000359437
Ethics application status
Approved
Date submitted
17/12/2015
Date registered
21/03/2016
Date last updated
23/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of post-operative mobility recovery in participants undergoing keyhole colorectal surgery treated with intraperitoneal ropivacaine/placebo for post-op pain management.
Scientific title
A double-blinded randomised placebo-controlled clinical trial assessing postoperative recovery using intraperitoneal local anaesthetic in laparoscopic colorectal surgery.
Secondary ID [1] 288108 0
JHGIS08
Universal Trial Number (UTN)
Trial acronym
LAPLAP study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-operative pain 296971 0
Condition category
Condition code
Surgery 297228 297228 0 0
Other surgery
Anaesthesiology 298176 298176 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ropivacaine hydrochloride 0.2% continuous infusion of up to 4mls per hour (depending on patient weight, as prescribed by the treating Anaesthetist) via intraperitoneal catheter administered post-operatively up to 5 days as determined by the treating surgical team or pain team.
Other anaesthetic agents for the operative procedure will be at the discretion of the treating Anaesthetist.
Intervention code [1] 293415 0
Treatment: Drugs
Comparator / control treatment
0.9% sodium chloride infusion of up to 4mls per hour (depending on patient weight) via intraperitoneal catheter.
Control group
Placebo

Outcomes
Primary outcome [1] 296814 0
Difference in pre-operative De Morton Mobility Index (DEMMI) score and post-operative score.
Timepoint [1] 296814 0
Day 7 and 30 post-operatively
Secondary outcome [1] 319432 0
Postoperative analgesic consumption (MilliEquivalents of morphine) from medical record pain management prescription charts.
Timepoint [1] 319432 0
Post-operatively daily for 3 days.
Secondary outcome [2] 319433 0
Postoperative pain scores (Visual Analogue Scales 0-10)
Timepoint [2] 319433 0
Daily for 3 days
Secondary outcome [3] 319434 0
Postoperative forced expiratory volume in first second (FEV1),
Timepoint [3] 319434 0
Daily for 3 days and day 30
Secondary outcome [4] 319435 0
Time to first flatus as per medical record documentation.
Timepoint [4] 319435 0
Post-operatively in hours to when first passage of flatus occurs.
Secondary outcome [5] 319436 0
Time to first bowel motion as per medical record documentation.
Timepoint [5] 319436 0
Post-operatively in hours to when first bowel motion occurs.
Secondary outcome [6] 319437 0
Ileus rates in groups (lack of any evidence of gut function >48 hours) as per medical record documentation of flatus and bowel motion activity.
Timepoint [6] 319437 0
Post-operatively until discharge.
Secondary outcome [7] 319438 0
Post-operative nausea and vomiting graded by the Simplified PONV impact scale
Timepoint [7] 319438 0
Daily for 3 days.
Secondary outcome [8] 319439 0
Length of hospital stay (days) as per medical record.
Timepoint [8] 319439 0
To time of hospital discharge
Secondary outcome [9] 319440 0
Post-operative surgical complications graded by the Clavien-Dindo Classification of Surgical Complications.
Timepoint [9] 319440 0
Up to day 30 post-operatively
Secondary outcome [10] 319441 0
Patient satisfaction with analgesia after discharge (Likert scale and percent satisfaction)
Timepoint [10] 319441 0
After discharge up to day 7.
Secondary outcome [11] 319442 0
Surgical Recovery Score
Timepoint [11] 319442 0
Daily for 3 days then at day 7 and day 30.
Secondary outcome [12] 322030 0
Postoperative forced vital capacity (FVC)
Timepoint [12] 322030 0
Daily for 3 days and day 30
Secondary outcome [13] 322033 0
Postoperative peak expiratory flow (PEF)
Timepoint [13] 322033 0
Post-operatively daily for 3 days and day 30

Eligibility
Key inclusion criteria
All patients undergoing elective or semi-urgent booked laparoscopic colorectal resection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients from the above group will be excluded if they:
-are under 18 years of age, or
-Refuse or are unable to give written informed consent to participate in the study, or
-have severe renal impairment or
-receive an epidural, spinal or other neuroaxial anaesthetic, or
-receive an operation that involved extra incisions outside the abdominal wall (such as abdomino-perineal resections) or
-have a known allergy or adverse drug reaction to local anaesthetic agents or morphine or fentanyl, or
-have a history of arrhythmia or long QT syndrome associated with the drugs used in this trial, or
-remain intubated post procedure
-Pregnant or lactating females
-Are taking regular opiate narcotics pre-operatively

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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/04/2016
Actual
8/07/2016
Date of last participant enrolment
Anticipated
Actual
5/12/2017
Date of last data collection
Anticipated
Actual
28/02/2018
Sample size
Target
96
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4871 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [2] 4872 0
Newcastle Private Hospital - New Lambton Heights
Recruitment postcode(s) [1] 12379 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 12380 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 292526 0
Self funded/Unfunded
Name [1] 292526 0
unfunded
Country [1] 292526 0
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Lookout Road
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 291236 0
None
Name [1] 291236 0
Address [1] 291236 0
Country [1] 291236 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294001 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 294001 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 294001 0
Australia
Date submitted for ethics approval [1] 294001 0
26/11/2015
Approval date [1] 294001 0
02/03/2016
Ethics approval number [1] 294001 0
15/12/16/3.01

Summary
Brief summary
Most colorectal surgery is now performed laparoscopically. Therefore most pain is deep inside the abdomen rather than the small incisions on the abdominal wall.
This study would like to use a pain management technique that uses local anaesthetic infused via plastic catheters into the intraperitoneal space in the abdomen, close to the internal incisions. It is hoped that by doing this patients will need to use less opioid drugs and thereby avoid the side effects of these drugs and possibly recover more quickly from the surgical procedure with less pain.

Currently there are many different pain management techniques used after surgery and include:
-Intravenous pain medication with opioid drugs such as Morphine or Fentanyl.
-Epidural (small plastic tube inserted near spinal cord where medication can be given) with a combination of local anaesthetic drugs +/- morphine-like drugs.
-Local anaesthetic blocks via small plastic tubes placed between the abdominal muscles at the time of operation and allow for local anaesthetic to be given between these muscles.
-Oral pain medication such as paracetamol and oxycodone.
-A combination of any of the above techniques.
These techniques can have side effects especially with the Morphine-like drugs that can be a problem in patients having surgery on the bowel and include:
-Nausea and vomiting
-Reduced bowel function (constipation or bowel temporarily stops working - ileus)
-Drowsiness or sleepiness
-Slowed respiratory rate and reduced cough
-Reduced mobility leading to prolonged bedrest
-Increased risk of blood clots due to immobility

Because of these side effects the study is designed to see if the local anaesthetic infused intraperitoneally will result in improved pain relief, mobility, earlier return of gut function and less complications,
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 805 805 0 0
/AnzctrAttachments/369753-1512163.01 Approval Multi-site LeadHREC (2).pdf

Contacts
Principal investigator
Name 62070 0
Dr Stephen Smith
Address 62070 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 62070 0
Australia
Phone 62070 0
+61 2 49855153
Fax 62070 0
Email 62070 0
[email protected]
Contact person for public queries
Name 62071 0
Ms Rosemary Carroll
Address 62071 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 62071 0
Australia
Phone 62071 0
+61 2 49855153
Fax 62071 0
Email 62071 0
[email protected]
Contact person for scientific queries
Name 62072 0
Dr Stephen Smith
Address 62072 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 62072 0
Australia
Phone 62072 0
+61 2 49855153
Fax 62072 0
Email 62072 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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