Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000298415
Ethics application status
Approved
Date submitted
1/03/2016
Date registered
7/03/2016
Date last updated
12/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pectoral nerve blocks and quality of recovery following breast surgery
Scientific title
Do pectoral nerve blocks improve patient quality of recovery following breast surgery?: a randomized controlled trial
Secondary ID [1] 288667 0
Nil Known
Universal Trial Number (UTN)
U1111-1180-2301
Trial acronym
PECS2 RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post surgical quality of recovery 297857 0
Post surgical pain 297889 0
Condition category
Condition code
Anaesthesiology 298032 298032 0 0
Anaesthetics
Anaesthesiology 298033 298033 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound-guided pectoral nerve block (Pecs 2) with ropivacaine 0.475% 0.2ml/kg in the plane between pectoralis major and minor AND ropivacaine 0.475% 0.25ml/kg in the plane deep to pectoralis minor will be injected by anaesthetist prior to general anaesthesia, in addition to standardised general anaesthesia. Identical volume of 0.9% sodium chloride (normal saline) infiltrated subcutaneously by surgeons at wound edges prior to wound closure. Adherence is ensured by Pecs 2 block being performed by anaesthetists trained in Pecs 2 block. Surgeons will be notified of the protocol for wound infiltration.
Intervention code [1] 294081 0
Treatment: Drugs
Comparator / control treatment
Local anaesthetic infiltration subcutaneously by surgeons involving injection of identical volume of ropivacaine 0.475% along wound edges prior to wound closure, and ultrasound-guided placebo nerve block with 0.9% sodium chloride (normal saline) 0.2ml/kg in the plane between pectoralis major and minor AND normal saline 0.25ml/kg in the plane deep to pectoralis minor by the anaesthetist prior to general anaesthesia, in addition to standardised general anaesthesia. Note that the placebo nerve block will be performed in the exact same way as the Pecs 2 block (in terms of approach and endpoint of drug delivery as viewed on ultrasound) with the only difference being the used of normal saline instead of ropivacaine. Adherence is ensured by Pecs 2 block being performed by anaesthetists trained in Pecs 2 block. Surgeons will be notified of the protocol for wound infiltration.
Control group
Active

Outcomes
Primary outcome [1] 297547 0
Quality of recovery score 15 (QoR15)
Timepoint [1] 297547 0
24 hours post surgery
Secondary outcome [1] 321365 0
Brief Pain Inventory Score
Timepoint [1] 321365 0
3 months post surgery
Secondary outcome [2] 321366 0
Oral morphine equivalents - outcome is assessed by review of medical records.
Timepoint [2] 321366 0
24 hours post surgery
Secondary outcome [3] 321367 0
Adverse effects e.g. nausea and vomiting, use of antiemetics. Outcome is assessed by review of medical records and question nausea and vomiting will be assessed as part of the QoR15
Timepoint [3] 321367 0
24 hours post surgery

Eligibility
Key inclusion criteria
Adult female patients undergoing elective unilateral breast surgery [unilateral wide local excision WLE with or without sentinal lymph node biopsy, axillary clearance/dissection and unilateral mastectomy], American Society of Anesthesiologists (ASA) score I to III
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Male gender, body mass index > 45 kg/m2, perceived inability to complete study questionnaires (for example, non-native English speakers, cognitive impairment, psychiatric illness), body weight less than 50kg, significant renal or liver impairment, allergy to drugs used in the protocol, pregnancy, alcohol or drug abuse, opioid dependence and infection at the injection site.

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)
Patients will be enrolled after written and verbal consent are obtained at least 1 day prior to surgery. Before study commencement, a computer-generated permuted block randomisation schedule will be generated. The randomisation schedule will be stratified according to mastectomy or surgery not involving mastectomy. Study medication will be prepared by the hospital pharmacy into identical syringes containing either 0.9% normal saline or 0.475% ropivacaine according to randomisation schedule with details stored in a register. The syringes will be sealed and labelled with the name of the project, the investigators name, patient’s hospital identification number and consecutive numbers according to a computer-generated block randomisation. The patients will receive these study solutions as Pecs II block procedure and surgical infiltration. Both ropivacaine and saline are clear, colourless, non-viscous, odourless solutions and are identical in appearance. The syringes will be labelled 'For anaesthetist', 'For surgeon', to indicate allocation of drug according to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
By computer
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
Patients in Pecs II group: will receive total of 0.45ml/kg 0.475% ropivacaine as injectate for the Pecs II block (0.2 ml/kg in the plane between pectoralis major and minor; 0.25ml/kg in the plane deep to pectoralis minor) performed by the anaesthetist prior to general anaesthesia under light sedation and identical volume of normal saline as injectate for surgical subcutaneous infiltration at the surgical site just before wound closure. Patients in the Local Infiltration group: will receive 0.45ml/kg normal saline as injectate for the placebo block (0.2 ml/kg in the plane between pectoralis major and minor; 0.25ml/kg in the plane deep to pectoralis minor) performed by the anaesthetist prior to general anaesthesia under light sedation and identical volume of 0.475% ropivacaine as injectate for surgical subcutaneous infiltration at the surgical site just before wound closure. Both groups of patients will be given a standardised general anaesthesia regime and robust multimodal analgesia regime. Quality of recovery will be assessed by Quality of Recovery 15 (QoR15) questionnaire at 24 hours post operatively. Brief Pain Inventory Questionnaire will be administered at 3 months.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome measure of the study is the quality of recovery as measured by the QoR-15. Stark has reported a QoR-15 score of 118 (20), mean (SD) for minor surgery, with the standard deviation (SD) ranging between 20 - 23 for surgeries categorized as minor, intermediate and major (Stark PA et al). A difference between groups of 10 could be expected and is considered clinically significant. The study by Stark and colleagues included a range of surgical types into each category (minor, major), however we are studying a homogenous surgical population, therefore a reduced standard deviation of less than 15 is expected (personal communication with developer of QoR P Myles, March 2015). The sample size calculation was made using Stata IC 12.1 (StataCorp, College Station, TX, USA) and using a statistical power of 0.90 and a type 1 error estimate of 5% (2-tailed alpha value of 0.05), a clinically significant effect of 10 and a SD of 14 we calculate that 42 participants will be required in each group. To allow for attrition and variability in parameters used to estimate sample size, we will recruit an additional 20 participants therefore the total sample size will be 104. Group baseline characteristics will be examined for confounding factors. Normally distributed data will be presented as mean (SD) and will be analysed with the Student t test. Non-normally distributed continuous and ordinal data will be presented as median (10th – 90th percentiles) and analysed with the Mann-Whitney U test. Categorical variables will be presented as number (percentage) and analysed using the chi-square test. Normally distributed data. For comparison of the primary outcome we will calculate the median difference and its 95% confidence interval (CIs). All statistical analyses will be performed using Stata IC 12.1 (StataCorp, College Station, TX, USA). For all analyses, a p value < 0.05 will be considered statistically significant. An intention-to-treat analysis will be used.

Reference
Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013; 118(6): 1332-40

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/03/2016
Actual
16/08/2016
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
104
Accrual to date
90
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5378 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 8054 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 12831 0
3065 - Fitzroy
Recruitment postcode(s) [2] 16095 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 10548 0
New Zealand
State/province [1] 10548 0
Hamilton

Funding & Sponsors
Funding source category [1] 293023 0
Other Collaborative groups
Name [1] 293023 0
Australian and New Zealand College of Anaesthetists (ANZCA)
Country [1] 293023 0
Australia
Primary sponsor type
Individual
Name
Dr Gloria Seah
Address
630 St Kilda Road, Melbourne, VICTORIA 3004
Country
Australia
Secondary sponsor category [1] 291799 0
None
Name [1] 291799 0
Address [1] 291799 0
Country [1] 291799 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294534 0
St Vincent's Hospital Melbourne Human Research Ethics Committee D
Ethics committee address [1] 294534 0
Ethics committee country [1] 294534 0
Australia
Date submitted for ethics approval [1] 294534 0
20/01/2016
Approval date [1] 294534 0
02/03/2016
Ethics approval number [1] 294534 0
HREC/16/SVHM/7

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

Contacts
Principal investigator
Name 64046 0
Dr Gloria Seah
Address 64046 0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VICTORIA 3065
Country 64046 0
Australia
Phone 64046 0
+61392314253
Fax 64046 0
Email 64046 0
[email protected]
Contact person for public queries
Name 64047 0
Gloria Seah
Address 64047 0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VICTORIA 3065
Country 64047 0
Australia
Phone 64047 0
+61392314253
Fax 64047 0
Email 64047 0
[email protected]
Contact person for scientific queries
Name 64048 0
Gloria Seah
Address 64048 0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy, VICTORIA 3065
Country 64048 0
Australia
Phone 64048 0
+61392314253
Fax 64048 0
Email 64048 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo For minor breast surgery, Pecs II block appears to... [More Details]
Study results articleYes Forthcoming pending final corrections

Documents added automatically
No additional documents have been identified.