Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000247673
Ethics application status
Approved
Date submitted
21/02/2014
Date registered
7/03/2014
Date last updated
23/01/2019
Date data sharing statement initially provided
23/01/2019
Date results information initially provided
23/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reduction Of Chronic Post-surgical Pain with Ketamine – A Pilot Study
Scientific title
A pilot study for a multicentre double-blind placebo controlled randomized Phase 4 study of the effect of ketamine on the development of chronic post-surgical pain in patients undergoing elective abdominal or non-cardiac thoracic surgery under general anaesthesia.
Secondary ID [1] 284139 0
Nil
Universal Trial Number (UTN)
Trial acronym
ROCKet Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic post-surgical pain 291222 0
Condition category
Condition code
Surgery 291569 291569 0 0
Other surgery
Anaesthesiology 291605 291605 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The effect of intravenous ketamine given prior to and for up to 24 hours following surgical incision on the prevalence and severity of chronic post-surgical pain at 4-6 months postoperatively. Ketamine dosage is 0. 5mg/kg bolus, followed by 0.25 mg/kg/hr intra-operatively. then 0.1 mg/kg/hr continued for 24 hour
Intervention code [1] 288834 0
Treatment: Drugs
Comparator / control treatment
Placebo saline
Control group
Placebo

Outcomes
Primary outcome [1] 291524 0
The incidence of chronic post-surgical wound-related pain reported by the patient using a structured questionnaire incorporating the modified brief pain inventory (mBPI).
Timepoint [1] 291524 0
4-6 months postoperatively.
Secondary outcome [1] 306968 0
The mean severity of chronic post-surgical wound-related pain measured using a Visual Analog Scale (0-100).
Timepoint [1] 306968 0
4-6 months postoperatively
Secondary outcome [2] 306969 0
Quality of life estimates using the WHODAS and Kessler K-10 Depression scale, and their relationship to pain prevalence and severity
Timepoint [2] 306969 0
4-6 months after surgery.
Secondary outcome [3] 306970 0
The severity of acute postoperative pain measured using a Visual Analog Scale (0-100).
Timepoint [3] 306970 0
In the first 24, 48 and 72 hours postoperative
Secondary outcome [4] 307048 0
Opioid and other analgesic consumption
Timepoint [4] 307048 0
The first 24, 48 and 72 hours postoperative
Secondary outcome [5] 307049 0
The relationship of the severity of acute postoperative pain to chronic post surgical pain prevalence and severity using a Visual Analog Scale (0-100).
Timepoint [5] 307049 0
4-6 months postoperative

Eligibility
Key inclusion criteria
Patients undergoing elective abdominal or non-cardiac thoracic surgery under general anaesthesia involving a skin incision at least 8 cm in length and a hospital stay of at least one night postoperatively.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to provide informed consent
Patients with poor English language comprehension
Patients who are pregnant
Body mass index (BMI) over 40 kg/m2 or weight over 130kg
ASA grade 4 or 5.
Uncontrolled hypertension (SBP over 180 mmHg) or heart failure
Intracranial surgery
History of haemorrhagic stroke
Previous adverse reaction to ketamine
Patients with a documented chronic pain syndrome identified using the mBPI
Patients with epilepsy or history of convulsions
Patients with a history of psychiatric problems or drug abuse or illegal activities

Study design
Purpose of the study
Prevention
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 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
80 patients.
This study is a pilot study and is not powered to demonstrate a statistically significant difference in the primary endpoint

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/02/2014
Date of last participant enrolment
Anticipated
30/09/2014
Actual
13/05/2015
Date of last data collection
Anticipated
Actual
31/12/2015
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288772 0
Charities/Societies/Foundations
Name [1] 288772 0
Australian and New Zealand College of Anaesthetists
Country [1] 288772 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Rd
Heidelberg 3084
VIC
Country
Australia
Secondary sponsor category [1] 287471 0
None
Name [1] 287471 0
Address [1] 287471 0
Country [1] 287471 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
There is a well established physiological basis for the proposition that a potent NMDA receptor antagonist such as the widely available drug ketamine given peri-operatively may reduce the development of chronic postsurgical pain in patients undergoing major surgery, and this proposition is supported by available data pooled from small placebo controlled published studies, and a large study on N2O. The potential benefits of this in reducing the burden of chronic pain in the community are substantial.
A large multicentre randomized trial is needed in patients undergoing major surgery to determine whether chronic post-surgical pain is reduced using intravenous ketamine given peri-operatively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46434 0
A/Prof Philip Peyton
Address 46434 0
Dept of Anaesthesia
Austin Health
145 Studley Rd
Heidelberg 3084
VIC
Country 46434 0
Australia
Phone 46434 0
+61402282398
Fax 46434 0
Email 46434 0
[email protected]
Contact person for public queries
Name 46435 0
A/Prof Philip Peyton
Address 46435 0
Dept of Anaesthesia
Austin Health
145 Studley Rd
Heidelberg 3084
VIC
Country 46435 0
Australia
Phone 46435 0
+61402282398
Fax 46435 0
Email 46435 0
[email protected]
Contact person for scientific queries
Name 46436 0
A/Prof Philip Peyton
Address 46436 0
Dept of Anaesthesia
Austin Health
145 Studley Rd
Heidelberg 3084
VIC
Country 46436 0
Australia
Phone 46436 0
+61402282398
Fax 46436 0
Email 46436 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Peyton P, Wu C, Jacobson T, Hogg M, Zia F, Leslie ... [More Details]

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
239Study results articleYes Peyton P, Wu C, Jacobson T, Hogg M, Zia F, Leslie ... [More Details]
2322Basic resultsNo 365844-(Uploaded-21-01-2019-17-36-05)-Basic results summary.docx
2870Plain language summaryNo Chronic post-surgical pain (CPSP) is a common and ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Effect of a Perioperative Ketamine Infusion on the Incidence of Chronic Postsurgical Pain-A Pilot Study.2017https://dx.doi.org/10.1177/0310057X1704500408
N.B. These documents automatically identified may not have been verified by the study sponsor.