Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000589886
Ethics application status
Approved
Date submitted
10/04/2021
Date registered
18/05/2021
Date last updated
6/04/2023
Date data sharing statement initially provided
18/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of lignocaine on pain outcomes for women undergoing gynaecological surgery for chronic pelvic pain
Scientific title
The effect of perioperative intravenous lignocaine on pain outcomes at operative gynaecological laparoscopy in women with chronic pelvic pain, a randomised controlled trial.
Secondary ID [1] 303872 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pelvic pain 321444 0
Condition category
Condition code
Anaesthesiology 319205 319205 0 0
Pain management
Renal and Urogenital 319592 319592 0 0
Other renal and urogenital disorders
Surgery 319593 319593 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double blind randomised controlled trial of the use of peri-operative intravenous lignocaine compared to placebo matched control intravenous saline at the time of operative laparoscopy for chronic pelvic pain conditions.

Description of drug intervention:
Name - Lignocaine, or Lidocaine (International Non-proprietary Name)
Dose, duration and mode of administration - 1.5mg/kg intravenous bolus with induction of anaesthesia (max 200mg), followed by 2mg/kg/hour intravenous infusion during anaesthesia. Cease infusion prior to emergence from anaesthesia.
Intervention code [1] 320177 0
Treatment: Drugs
Comparator / control treatment
Sodium chloride 0.9% intravenous bolus (1.5ml/10kg) with induction, followed by intravenous infusion (2ml/10kg/hr) during anaesthesia
Control group
Placebo

Outcomes
Primary outcome [1] 327078 0
Visual Analogue Scale (VAS) pain scores
Timepoint [1] 327078 0
Measured at 2, 4, 6 and 12-24 hours postoperative
Secondary outcome [1] 393691 0
Postoperative morphine equivalent dose rescue analgesia use - data collected from medical records
Timepoint [1] 393691 0
In the first 24hours
Secondary outcome [2] 393692 0
Time to first breakthrough analgesic request - data collected from medical records
Timepoint [2] 393692 0
24 hours postoperative
Secondary outcome [3] 393693 0
Length of hospital stay - data collected from medical records
Timepoint [3] 393693 0
Postoperative period - from immediately following the surgery to time of discharge under direct observation during inpatient stay, and reassessed again at 1 week via patient survey
Secondary outcome [4] 393694 0
Potential adverse effects of intravenous lignocaine
- Numbness around mouth/tongue
- Light-headedness
- Ringing in ears
- Twitches
- Increased sedation
- Slurred speech
- Confusion
- Hallucinations
- Hypotension
- Bradycardia
- Other

Data collected from medical records
Timepoint [4] 393694 0
Duration of the study - for each participant follow up will continue until 3 months postoperatively
Secondary outcome [5] 393695 0
Pain assessment 1-week postoperative (daily VAS and analgesia use questionnaire for 3-7 days) - questionnaire designed specifically for this study
Timepoint [5] 393695 0
1 week post operative
Secondary outcome [6] 393696 0
Change in pain assessment on specifically designed questionnaire from preoperative to postoperative assessment at 3 months - questionnaire designed specifically for this study
Timepoint [6] 393696 0
3 months postoperative
Secondary outcome [7] 393697 0
Change in Quality of life scores (12-item short form survey [SF-12], Fatigue survey score) from preoperative to postoperative assessment at 6 weeks and 3 months
Timepoint [7] 393697 0
6 weeks and 3 months
Secondary outcome [8] 393954 0
Psychological distress as measured by K10 score, Change from pre-operative to 3 months postoperative
Timepoint [8] 393954 0
3 months post operative

Eligibility
Key inclusion criteria
- Women requiring elective operative gynaecological laparoscopy for benign indication as determined and agreed by both the surgeon and the participant.
- Experience of pelvic pain on most days in the preceding 6 months
- Over 18years old and premenopausal at the time of the surgery.
- Participants who understand the conditions of the study and are willing to participate for the duration of study including all follow-up.
- Participants who are capable of, and have given, informed consent to their participation in the study.
- English language or an available translator sufficient to complete the validated quality of life instruments.
- Surgery at Moorabbin Hospital under specialised Endosurgery unit
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindications to lignocaine (Hypersensitivity; Myasthenia gravis; Severe shock; Supraventricular arrhythmia; Impaired cardiac conduction; Stokes-Adams syndrome or severe degrees of sinoatrial, atrioventricular or intraventricular heart block unless the participant has an artificial pacemaker; Severe renal or liver disease; Use of beta blocker medication e.g. propranolol, metoprolol, atenolol, bisoprolol; Use of Anti-arrhythmic medication e.g. amiodarone, flecainide sotalol, digoxin; Electrolyte abnormalities)
- No significant and persisting pain component to presentation in preceding 6 months.
- Known or suspected malignancy
- Pregnancy
- Requirement for alternative analgesia regimen
- Current/recent use of methadone within 6months of surgery

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)
Randomisation will be performed on the morning of surgery using an Excel randomisation table allocating each participant a study group and providing a unique PIN which will be used to conceal group allocation and collect data in a de-identified manner.

After randomisation on the day of surgery, the participant’s group allocation will be notified to a registered nurse or anaesthetist not involved in clinical care of the patient who prepares the intravenous solution (lignocaine or placebo). The solution is identified with the participant’s PIN which is thereon used to conceal the participant’s allocated group. This preparation is then given to the anaesthetist for the case. All healthcare workers and research investigators involved in the patient's care, data collection and analysis will remain blinded to participant’s group allocation until the end of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
N/A
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For our power calculation we assumed an equal standard deviation of 14mm in VAS pain scores between groups based on previous studies of VAS pain scores in women with chronic pelvic pain which is concordant with VAS scores in patients following spinal surgery randomised to lignocaine versus placebo. To achieve 80% of detecting a 10mm difference between groups with a type 1 error rate of 0.05, we required a sample size of 31 in each group. Accounting for a compliance rate of 90% we aimed for a sample size of 70 participants (35 in each group).

Continuous variable data means ± standard deviation (e.g. VAS scores) will be compared between groups using paired t-test if normally distributed and Mann-Whitney test if not normally distributed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/05/2021
Actual
16/06/2021
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
29/04/2024
Actual
Sample size
Target
70
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19055 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [2] 24492 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [3] 24493 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 33604 0
3165 - Bentleigh East
Recruitment postcode(s) [2] 40076 0
3175 - Dandenong
Recruitment postcode(s) [3] 40077 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 308261 0
Charities/Societies/Foundations
Name [1] 308261 0
Australian Gynaecological Endoscopy & Surgery
Country [1] 308261 0
Australia
Primary sponsor type
Hospital
Name
Monash health
Address
823-865 Centre Rd, Bentleigh East VIC 3165
Country
Australia
Secondary sponsor category [1] 309061 0
None
Name [1] 309061 0
Address [1] 309061 0
Country [1] 309061 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308239 0
Monash Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 308239 0
Ethics committee country [1] 308239 0
Australia
Date submitted for ethics approval [1] 308239 0
Approval date [1] 308239 0
17/02/2021
Ethics approval number [1] 308239 0
RES-20-0000-859A

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

Contacts
Principal investigator
Name 110030 0
Dr Sasha Skinner
Address 110030 0
Monash Medical Centre, 246 Clayton Road, Clayton VIC 3168
Country 110030 0
Australia
Phone 110030 0
+61394161172
Fax 110030 0
Email 110030 0
[email protected]
Contact person for public queries
Name 110031 0
Sasha Skinner
Address 110031 0
Monash Medical Centre, 246 Clayton Road, Clayton VIC 3168
Country 110031 0
Australia
Phone 110031 0
+61394161172
Fax 110031 0
Email 110031 0
[email protected]
Contact person for scientific queries
Name 110032 0
Sasha Skinner
Address 110032 0
Monash Medical Centre, 246 Clayton Road, Clayton VIC 3168
Country 110032 0
Australia
Phone 110032 0
+61394161172
Fax 110032 0
Email 110032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data will not be available for this trial to protect patient confidentiality and privacy. Case by case requests for de-identified individual participant data will be assessed
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
case-by-case basis at the discretion of Research Team
Available for what types of analyses?
Examples of situations for when availability of IPD might be considered include:
- to achieve the aims in the approved proposal
- for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.