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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02449720




Registration number
NCT02449720
Ethics application status
Date submitted
28/04/2015
Date registered
20/05/2015

Titles & IDs
Public title
Intraperitoneal Local Anaesthetic in Bowel Surgery
Scientific title
The Effect of Intraperitoneal Local Anaesthetic on Functional Recovery Following Bowel Resection: A Prospective Randomised Blinded Trial
Secondary ID [1] 0 0
150219
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Disorders 0 0
Condition category
Condition code

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

Active comparator: Laparoscopic Bowel Surgery: IPLA - Participants will undergo laparoscopic bowel surgery. Both on entry into the abdominal cavity and prior to dissection and post-operation but prior to closure of abdominal wall a 50 ml loading dose of IPLA (0.2% Ropivacaine) solution will be distributed throughout the abdomen. Following these bolus doses an ON-Q Painbuster continuous infusion pump will be placed in close proximity to the operative region of greatest dissection and a 10ml/hr intraperitoneal infusion of IPLA (0.2% Ropivacaine, 20mg/hr) solution commenced immediately post-operation and continued for 48 hrs without disruption.

Placebo comparator: Laparoscopic Bowel Surgery: Control - Participants will undergo laparoscopic bowel surgery. Both on entry into the abdominal cavity and prior to dissection and post-operation but prior to closure of abdominal wall a 50 ml loading dose of Control (0.9% Saline, 20mg/hr) solution will be distributed throughout the abdomen. Following these bolus doses an ON-Q Painbuster continuous infusion pump will be placed in close proximity to the operative region of greatest dissection and a 10ml/hr intraperitoneal infusion of Control (0.9% Saline, 20mg/hr) solution commenced immediately post-operation and continued for 48 hrs without disruption.

Active comparator: Open Bowel Surgery: IPLA - Participants will undergo open bowel surgery. Both on entry into the abdominal cavity and prior to dissection and post-operation but prior to closure of abdominal wall a 50 ml loading dose of IPLA (0.2% Ropivacaine) solution will be distributed throughout the abdomen. Following these bolus doses an ON-Q Painbuster continuous infusion pump will be placed in close proximity to the operative region of greatest dissection and a 10ml/hr intraperitoneal infusion of IPLA (0.2% Ropivacaine, 20mg/hr) solution commenced immediately post-operation and continued for 48 hrs without disruption.

Placebo comparator: Open Bowel Surgery: Control - Participants will undergo open bowel surgery. Both on entry into the abdominal cavity and prior to dissection and post-operation but prior to closure of abdominal wall a 50 ml loading dose of Control (0.9% Saline, 20mg/hr) solution will be distributed throughout the abdomen. Following these bolus doses an ON-Q Painbuster continuous infusion pump will be placed in close proximity to the operative region of greatest dissection and a 10ml/hr intraperitoneal infusion of Control (0.9% Saline, 20mg/hr) solution commenced immediately post-operation and continued for 48 hrs without disruption.


Treatment: Drugs: Ropivacaine
Intraperitoneal instillation and infusion

Treatment: Drugs: 0.9% Saline
Intraperitoneal instillation and infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline of the Surgical Recovery Scale to Day 45
Timepoint [1] 0 0
Baseline (preoperative), and postoperative days 1, 3, 7, 30 and 45
Secondary outcome [1] 0 0
Change in Pain Over Time to Day 7 (Subjective)
Timepoint [1] 0 0
At postoperative hours 3, 6, 12, 24, 48, and 72, and at day 7
Secondary outcome [2] 0 0
Change in Pain Over Time to day 3 (Objective)
Timepoint [2] 0 0
Postoperative day 1, 2, and 3
Secondary outcome [3] 0 0
Recovery of Normal Bowel Function
Timepoint [3] 0 0
Inpatient postoperative period (variable), and expected duration of 3-7 days.
Secondary outcome [4] 0 0
Time to Readiness for Discharge
Timepoint [4] 0 0
up to 30 days
Secondary outcome [5] 0 0
Operative Complications
Timepoint [5] 0 0
30 days post operation

Eligibility
Key inclusion criteria
* The study population will include adults from the Central Adelaide Local Health network catchment area, South Australia.
* Patients known to the Colorectal Surgical Unit who have provided informed consent to undergo elective large bowel resection for any indication or undergoing reversal of Hartmann's Procedure will be invited to participate in this study.
* Potential participants will then be provided with an Information Sheet and encouraged to take the time to read it, discuss it with anyone they like, and ask any questions they have prior to deciding if they wish to participate. They will be reassured that participation is voluntary and there is no disadvantage to them if they decide not to participate.
* After obtaining informed consent, eligibility for inclusion will be determined based on health questions and blood results.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Under 18 years of age or over age 90.
* Allergy to local anaesthetic.
* Underlying medical conditions requiring deviation from the proposed anaesthetic protocol i.e., use of spinal or epidural anaesthesia rather than general anaesthesia.
* American Society of Anesthesiologists (ASA) >=4 due to the higher likelihood or morbidity and mortality, which may confound resulting data.
* Severe underlying cardiovascular disease including conduction abnormalities, ischaemic heart disease or congestive heart failure, or use of amiodarone as a regular medication due to a higher risk or cardiac arrest under general anaesthetic or during use of local anaesthesia.
* Chronic Renal Failure (CRF) Stage 3 (GFR > 60 based on two samples a minimum 90d apart).
* The pharmacokinetics of ropivacaine is not affected by renal failure although the renal clearance of its main metabolite (S)-2',6'-pipecoloxylidide (PPX) correlates with creatinine clearance, non-renal clearance compensates for reduced renal clearance in most patients.
* GFR will be calculated using the Cockcroft Gault equation for creatinine clearance (CrCl) : CrCl ml/min = [140-age(years)] x bodyweight (kg) / R x serum creatinine (micromol/L)
* R = 0.815 for males, 0.85 for females
* Hepatic dysfunction of Child-Pugh class B or C. Patients with end-stage liver disease have about a 60% lower mean ropivacaine clearance than healthy subjects and are thus expected to have over two-fold higher steady-state ropivacaine plasma concentrations during a continuous ropivacaine infusion.
* Concurrent or recent (within 3 months) use of fluvoxamine, enoxacin, ketoconazole, or cimetidine. These are potent CYP (cytochrome P450) 1A2, 2E1, or 3A4 inhibitors that have been shown to reduce ropivacaine clearance in vivo or in in vitro models. Potential participants concurrently using other potent CYP1A2, 2E1, or 3A4 inhibitors, where it is unclear if there is an effect on ropivacaine clearance, will be included or excluded from the study at the discretion of their study specialist anaesthetist.
* Abdominal-perineal resections (APR) due to the greater area of dissection and skin incision which will increase the level of baseline somatic pain felt by a patient.
* Requirement for postoperative drain in-situ, as this will drain the experimental solution out of the abdomen.
* Preoperative systemic steroid dependence due to derangement of the inflammatory response.
* Preoperative chronic pain illness including fibromyalgia, chronic regional pain syndrome, chronic fatigue syndrome, non specific chronic pain requiring daily opiate use, and history of alcohol or drug dependence due to the impact these have on subjective interpretation of pain and tolerance to opioid requiring significantly higher dosing regimens.
* Inability to consent or complete data scores in the study questionnaires due to cognitive impairment and/or language barrier.
* Pregnancy or breastfeeding.

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 4
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
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
4000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Adelaide Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Adelaide
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of South Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Saint Andrew's Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Calvary North Adelaide Hospital
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jaime A Duffield, BMBS PhD
Address 0 0
Royal Adelaide Hospital, Colorectal Surgical Unit Research Registrar
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT02449720