Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000584831
Ethics application status
Approved
Date submitted
18/03/2021
Date registered
17/05/2021
Date last updated
12/04/2023
Date data sharing statement initially provided
17/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a paracervical block prior to total laparoscopic hysterectomy on patient's quality of recovery.
Scientific title
Paracervical local anaethesia to mitigate post operative pain after total laparoscopic hysterectomy: A single centered, randomised, double-blinded, placebo-controlled, phase II study comparing the use of the paracervical block versus placebo.
Secondary ID [1] 303694 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
PRE-EMPT
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Post operative pain 321104 0
Hysterectomy 321638 0
Condition category
Condition code
Anaesthesiology 318900 318900 0 0
Pain management
Surgery 319377 319377 0 0
Other surgery
Reproductive Health and Childbirth 319378 319378 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive 20mL of bupivacaine 0.5% with 1:200,000 adrenaline infiltrated via paracervical block, after induction of general anaesthesia and prior to the initial surgical incision. The intervention is TGA approved.

Five millilitres of the solution will be injected at the 3, 5, 7, and 9 o’clock positions of the cervicovaginal junction at a depth of 10mm as described in the 7th edition of Te Linde’s Operative Gynecology.

The injection will be prepared at the hospital pharmacy. The Study Coordinator will deliver this to the surgeon in theatre. A copy of the randomisation sheet documenting the drug administered will be filed in the patients medical records. The surgeon, patient and anaesthetist will not be aware of which preparation is used.
Intervention code [1] 319992 0
Prevention
Intervention code [2] 319993 0
Treatment: Surgery
Intervention code [3] 320325 0
Treatment: Drugs
Comparator / control treatment
The control group will receive a placebo of 20mL of 0.9% sodium chloride via paracervical injection after induction of general anaesthesia and prior to the initial surgical incision. The control group is TGA approved.

Five millilitres of the solution will be injected at the 3, 5, 7, and 9 o’clock positions of the cervicovaginal junction at a depth of 10mm as described in the 7th edition of Te Linde’s Operative Gynecology.

The injection will be prepared at the hospital pharmacy. The Study Coordinator will deliver this to the surgeon in theatre. A copy of the randomisation sheet documenting the drug administered will be filed in the patients medical records. The surgeon, patient and anaesthetist will not be aware of which preparation is used.
Control group
Placebo

Outcomes
Primary outcome [1] 327238 0
Completion of Quality of recovery questionnaire (QoR-15) to measure patient reported quality of recovery.
Timepoint [1] 327238 0
Measured 24-36 hours post operatively
Secondary outcome [1] 392852 0
Nausea and Vomiting
Timepoint [1] 392852 0
Assessed by requirement for anti-emetics, which will be determined by accessing patient medical records. Antiemetic use will be documented for the first 24 hours post surgery.
Secondary outcome [2] 392854 0
Pain score utilising visual analogue scale at rest
Timepoint [2] 392854 0
Measured at a single set timepoint between 24-36 hours post surgery.
Secondary outcome [3] 392976 0
Pain score utilising visual analogue scale at time of mobilisation
Timepoint [3] 392976 0
Measured at a single timepoint between 24-36 hours post surgery.
Secondary outcome [4] 392977 0
Pain score utilising visual analogue scale at rest
Timepoint [4] 392977 0
Measured at day 7 post operatively
Secondary outcome [5] 392978 0
Pain score utilising visual analogue scale at time of mobilisation
Timepoint [5] 392978 0
Measured at day 7 post operatively
Secondary outcome [6] 394327 0
Time to mobilisation after surgery by accessing patient medical records.
Timepoint [6] 394327 0
Measured up to 36 hours post surgery
Secondary outcome [7] 394328 0
Opioid use in Post Anesthesia Care Unit by accessing patient medical records.
Timepoint [7] 394328 0
Period whilst in Post Anesthesia Care Unit
Secondary outcome [8] 394329 0
Composite opioid measured by accessing patient medical records
Timepoint [8] 394329 0
Measured up to 24 hours post surgery
Secondary outcome [9] 394330 0
Time in Post Anesthesia Care Unit by accessing patient medical records.
Timepoint [9] 394330 0
Timepoint: from surgery finish time to time returned to ward
Secondary outcome [10] 394331 0
Completion of Quality of recovery questionnaire (QoR-15) to measure patient reported quality of recovery.
Timepoint [10] 394331 0
measured 7 days post surgery.
Secondary outcome [11] 394333 0
Assessing Length of Hospitalisation by accessing patient medical records
Timepoint [11] 394333 0
At the time of hospital discharge

Eligibility
Key inclusion criteria
1. Women undergoing a total laparoscopic hysterectomy (TLH) plus or mimus bilateral
Salpingo-oophorectomy (BSO) for any of the following conditions:
a. Heavy menstrual bleeding/ abnormal uterine bleeding
b. Stage 1 and 2 Endometriosis
c. Adenomyosis
d. Risk reduction surgery e.g. carriers of BRCA1/2 gene faults, Lynch Syndrome or
women considered high risk due to family history
e. Complex adnexal masses not suspicious for malignancy
f. Early stage cervical cancer requiring simple hysterectomy

2. Patients aged 18 years of age and over

3. Fluent in English
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Chronic pelvic pain

2. Recent opioid use (4 weeks prior to surgery)

3. Deeply infiltrative endometriosis (evidence of nodular disease on USS) or endometrioma.

4. Allergies to protocol drugs

5. Endometrial cancer

6. Patient requiring comprehensive surgical staging of malignant disease

7. Previous midline laparotomy

8. BMI >40kg/m2

9. Renal impairment (eGFR< 60 or Cr > 100)

10. Hepatic impairment (ALT> 40 or AST > 40)

11. Alcohol and drug dependency

12. Pregnancy

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)
The allocation sequence will be implemented by using the central telephone (interactive voice response system - IVRS).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generation of the allocation sequence will be by computer generated random numbers. The allocation sequence will be generated by the NHMRC Clinical Trials Centre, University of Sydney, and implemented by telephone interactive voice response system (IVRS).
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
Efficacy
Statistical methods / analysis
Data will be analysed using IBM SPSS (v. 26 IMB Corp.) with alpha 0.05 considered
statistically significant. Primary outcome QoR-15, and secondary outcomes VAS, time to
mobilisation; time in Patient Anesthetic Care Unit, hospital length in stay and demographic variables age, body mass index will be described using mean, standard deviation and median, with normality assessed using the Shapiro-Wilk test. Categorical secondary variables; opioid use in Patient Anesthetic Care unit, 24 hours and at discharge, and demographic variables co-morbidities will be described using frequency and percent. All variables will be described for total, intervention group and control group baseline. Intervention and control group data will also be described at each time point. A linear mixed model will be used to evaluate the change over the three time points for the primary outcome QoR-15 and secondary outcome VAS with fixed effects intervention group, and controlling for confounders (i.e. body mass index, time to mobilisation, etc.). Two-sided confidence intervals will be reported.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2021
Actual
7/09/2021
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
8/01/2024
Actual
Sample size
Target
94
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 18915 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 33420 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 308109 0
Hospital
Name [1] 308109 0
St John of God Subiaco Hospital
Country [1] 308109 0
Australia
Primary sponsor type
Hospital
Name
St John of God Subiaco Hospital
Address
12 Salvado Road
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 308858 0
None
Name [1] 308858 0
Address [1] 308858 0
Country [1] 308858 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308094 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 308094 0
Ethics committee country [1] 308094 0
Australia
Date submitted for ethics approval [1] 308094 0
08/03/2021
Approval date [1] 308094 0
03/05/2021
Ethics approval number [1] 308094 0
ref 1785

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

Contacts
Principal investigator
Name 109514 0
Dr Jade Acton
Address 109514 0
Western Australia Gynae and Surgery
5 Salvado Road
Subiaco WA 6008
Country 109514 0
Australia
Phone 109514 0
+61 8 9388 3495
Fax 109514 0
N/A
Email 109514 0
[email protected]
Contact person for public queries
Name 109515 0
Jade Acton
Address 109515 0
Western Australia Gynae and Surgery
5 Salvado Road
Subiaco WA 6008
Country 109515 0
Australia
Phone 109515 0
+61 8 9388 3495
Fax 109515 0
N/A
Email 109515 0
[email protected]
Contact person for scientific queries
Name 109516 0
Jade Acton
Address 109516 0
Western Australia Gynae and Surgery
5 Salvado Road
Subiaco WA 6008
Country 109516 0
Australia
Phone 109516 0
+61 8 9388 3495
Fax 109516 0
N/A
Email 109516 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.