Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000973819
Ethics application status
Approved
Date submitted
26/11/2020
Date registered
26/07/2021
Date last updated
11/07/2022
Date data sharing statement initially provided
26/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Paracervical Block on Post-operative Pain Following Benign Laparoscopic Hysterectomy: Objective Evaluation Of Parameters By Utilising A Single Centre Double Blind Randomized Controlled Trial
Scientific title
Effect of Paracervical Block on Post-operative Pain Following Benign Laparoscopic Hysterectomy: Objective Evaluation Of Parameters By Utilising A Single Centre Double Blind Randomized Controlled Trial
Secondary ID [1] 302879 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
The ROPPE trial
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Pain 322302 0
Condition category
Condition code
Surgery 317814 317814 0 0
Other surgery
Anaesthesiology 319958 319958 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Paracervical block with 0.5% Bupivacaine (with 1:200,000 Adrenaline) before benign laparoscopic hysterectomy

The study will objectively evaluate pain by measuring opioid intake postoperatively and by determining the impact in patient reported pain beyond the first 24 hours postextubation. Subsequent impact on return to normal activity and quality of life score (QOL) will also be determined using the widely validated tool EQ-5D 5L.

Two-arm single centre double blinded randomized placebo-controlled trial.
1. Treatment arm: Paracervical injection of 0.5% bupivacaine with adrenaline 1:200,000 (20 mL) containing 100mg of anhydrous bupivacaine HCL and 100 micrograms of adrenaline.
2. Placebo arm: Paracervical injection of normal saline (20 mL)

Cervical infiltration technique: Infiltration will be performed just prior the insertion of uterine manipulator by the primary surgeon. The content will be injected into the cervical stroma at the 3 and 9 o’clock positions with a depth of 2-3 cm, with 10 mL injected at each side.

Data will be routinely reviewed for completeness and accuracy as well as any evidence that may be indicative of participant risk. When the data are incomplete, attempts will be made to obtain the data whenever possible. Ensuring satisfactory response rate, data completeness and identifying missing data will remain responsibilities of the core research team. Every reasonable attempt will be made to determine the reason for a patient being lost to follow-up.

All participants will be given a standardised discharge prescription of twenty tablets of 5 mg Oxycodone for use as ‘PRN’.
Intervention code [1] 319166 0
Treatment: Drugs
Comparator / control treatment

Placebo arm: Paracervical injection of normal saline (20 mL)

Cervical infiltration technique: Infiltration will be performed just prior the insertion of uterine manipulator by the primary surgeon. The content will be injected into the cervical stroma at the 3 and 9 o’clock positions with a depth of 2-3 cm, with 10 mL injected at each side.
Control group
Placebo

Outcomes
Primary outcome [1] 325839 0

a. Patient reported pain score at rest 60 minutes post-extubation using Numeric Rate Scale (NRS)

Timepoint [1] 325839 0
1. 60 minutes post-extubation
Secondary outcome [1] 389284 0


Patient reported pain score at rest and with coughing on the first post-operative day using NRS
Timepoint [1] 389284 0
1. day 1: once, 24 hours post-operation
Secondary outcome [2] 396779 0
Opioid intake measurement by chart review: Use of oxycodone in day 1 and day 2
Timepoint [2] 396779 0
day 1 and day 2 post-operation
Secondary outcome [3] 396780 0
Return to usual daily activity: Patient reported activity score on day 7 post-op using EQ-5D-5L visual analogue scale
Timepoint [3] 396780 0
day 7 post-operation
Secondary outcome [4] 396781 0
Length of stay in hours (from the relevent electronic medical record)
Timepoint [4] 396781 0
From post extubation to discharge
Secondary outcome [5] 397686 0
Opioid intake post-discharge. This outcome will be assessed by conducting a phone interview on day 7 postoperative. Participants will be advised to keep a record of opioid intake at their discharge.
Timepoint [5] 397686 0
day 7 post-operation

Eligibility
Key inclusion criteria
1. Age greater than or equal to 18 years
2. Undergoing a total laparoscopic hysterectomy for benign indications (elective)
3. Indication of prophylactic surgery for at-risk patients can be included
4. With or without the following concurrent procedures:
a. Unilateral or bilateral salpingo-oophorectomy
b. Excision of endometriosis (below pelvic brim)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Allergy to either of Bupivacaine, Adrenaline, or any amide anaesthetics or opioids
2. Any other contraindications to Adrenaline or Bupivacaine
3. Weight <50kg or >100kg
4. Emergency hysterectomy
5. For non-English speaking participants: Unable to collect data adequately despite use of language interpreter
6. Excision of endometriosis that is above pelvic brim
7. Concurrent bowel or upper abdominal surgery
8. Chronic pain requiring ongoing opioid analgesia
9. Any indication of malignancy pre-op
10. Any intra-op suspicion/detection of malignancy requiring lymph node dissection
11. Any concomitant vaginal procedures (prolapse repair, mid-urethral slings, etc.)
12. Intraoperative conversion to laparotomy
13. Inability to perform the paracervical block due to anatomic abnormalities
14. Intraoperative injury to gastrointestinal or urologic tract that necessitated repair
15. Patient needing return to OT for complications
16. Procedures requiring extensive additional tissue manipulation such as:
a. Pelvic lymph node dissection
b. Laparoscopic pelvic floor repair procedures

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)
Yes, we will utilise the following methods:

1. sealed opaque envelopes
2. numbered and 'research' labelled research pack with syringes and consent and instructions 3. randomisation by computer software by an off-site research statistician
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will apply the computer-generated stratified block randomization method using excel to randomize participants into two groups (placebo and treatment) instead of simple sequence randomisation. This method will ensure a balance in sample size across the two groups
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
Efficacy
Statistical methods / analysis
The Student t test will be utilised to ensure baseline and intraoperative variable are evenly distributed between the control and treatment groups. Assuming normality of data distribution, the independent sample t test will be used to compare continuous variables and categorical variables will be analysed using chi-squired test. Pain score, opioid intake and return to activity will also be tested individually as continuous outcome variable in relation to the study variable (paracervical block) using adjusted analyses to compensate confounders.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/08/2021
Actual
25/11/2021
Date of last participant enrolment
Anticipated
25/08/2023
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
67
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18110 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 32102 0
3052 - Melbourne University

Funding & Sponsors
Funding source category [1] 307296 0
Charities/Societies/Foundations
Name [1] 307296 0
We have recieved grant from the Australasian Gynaecological Endoscopy and Surgery
Country [1] 307296 0
Australia
Primary sponsor type
Individual
Name
Tarana Lucky
Address
Advanced Laparoscopic Gynaecology Fellow
Gynaecology unit 1, The Royal Women's Hospital, Parkville, Melbourne
Victoria 3052
Country
Australia
Secondary sponsor category [1] 307937 0
Individual
Name [1] 307937 0
Dr Shamitha Kathurusinghe
Address [1] 307937 0
Consultant Gynaecologist, Gynaecology 1 Unit
Royal Women’s Hospital
Parkville, Melbourne
Victoria 3052
Country [1] 307937 0
Australia
Secondary sponsor category [2] 309749 0
Individual
Name [2] 309749 0
Dr. Catarina Ang
Address [2] 309749 0
Head of Gynaecology 1 Unit
Royal Women’s Hospital
Parkville, Melbourne
Victoria 3052
Country [2] 309749 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307393 0
Human Research Ethics Committee at the Royal Women's Hospital
Ethics committee address [1] 307393 0
Ethics committee country [1] 307393 0
Australia
Date submitted for ethics approval [1] 307393 0
06/01/2021
Approval date [1] 307393 0
17/06/2021
Ethics approval number [1] 307393 0
HREC/72575/RWH-21-05

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

Contacts
Principal investigator
Name 107078 0
Dr Tarana Lucky
Address 107078 0
The Royal Women's Hospital
20 Flemington Rd, Parkville VIC 3052
Country 107078 0
Australia
Phone 107078 0
+61402652634
Fax 107078 0
Email 107078 0
[email protected]
Contact person for public queries
Name 107079 0
Tarana Lucky
Address 107079 0
The Royal Women's Hospital
20 Flemington Rd, Parkville VIC 3052
Country 107079 0
Australia
Phone 107079 0
+61402652634
Fax 107079 0
Email 107079 0
[email protected]
Contact person for scientific queries
Name 107080 0
Tarana Lucky
Address 107080 0
The Royal Women's Hospital
20 Flemington Rd, Parkville VIC 3052
Country 107080 0
Australia
Phone 107080 0
+61402652634
Fax 107080 0
Email 107080 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.