Clinical Trial Results:
Does subarachnoid administration of hyperbaric prilocaine produce an improved recovery from anaesthesia when compared with hyperbaric bupivacaine when used to facilitate cervical cerclage in pregnant women at risk of pre-term loss?
A randomised controlled superiority Phase IV trial
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Summary
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EudraCT number |
2019-001548-23 |
Trial protocol |
GB |
Global end of trial date |
10 Sep 2025
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Oct 2026
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First version publication date |
01 Oct 2026
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Other versions |
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Summary report(s) |
PRILOCC_Clinical_Study Report_Docusigned |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
225703
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Additional study identifiers
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ISRCTN number |
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US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Guy's and St Thomas NHS Foundation Trust
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Sponsor organisation address |
Great Maze Pond, London, United Kingdom, SE1 9RT
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Public contact |
Dr Desire Onwochei, Guy's & St. Thomas' NHS Foundation Trust , +44 02071880645, Desire.Onwochei@gstt.nhs.uk
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Scientific contact |
Dr Desire Onwochei, Guy's & St. Thomas' NHS Foundation Trust , +44 02071880645, Desire.Onwochei@gstt.nhs.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
20 Aug 2025
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 Apr 2025
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Sep 2025
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine if subarachnoid hyperbaric 2% prilocaine produces a clinically meaningful reduction in time taken for regression of lower limb motor block when compared to hyperbaric 0.5% bupivacaine
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Protection of trial subjects |
The trial was conducted according to the protocol and in compliance with the principles of the Declaration of Helsinki (1996) as amended, the principles of Good Clinical Practice (GCP) and in accordance with Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, the Research Governance Framework for Health and Social Care, the Data Protection Act 1998 and other regulatory requirements as appropriate. The trial protocol and substantial amendments were reviewed by the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA).
Participants have the right to withdraw from the study at any time for any reason. The investigator also has the right to withdraw patients from the study drug in the event of inter-current illness, AEs, SAE’s, SUSAR’s, protocol violations, administrative reasons or other reasons. It is understood by all concerned that an excessive rate of withdrawals can render the study un-interpretable; therefore, unnecessary withdrawal of patients should be avoided. Should a patient decide to withdraw from the study, all efforts will be made to report the reason for withdrawal as thoroughly as possible.
The participant will be made aware of their right to withdraw at any time from the trial without giving reasons and without prejudicing his/her further treatment and will be provided with a contact point where he/she may obtain further information about the trial. The right of the participant to refuse participation without giving reasons will be respected.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
15 Nov 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 135
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Worldwide total number of subjects |
135
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EEA total number of subjects |
135
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
135
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
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Pre-assignment
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Screening details |
- | ||||||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
135 | ||||||||||||||||||
Number of subjects completed |
135 | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Assessor | ||||||||||||||||||
Blinding implementation details |
Prospective, parallel group, double-blind, randomised, controlled, superiority trial.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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PRILOCAINE | ||||||||||||||||||
Arm description |
Intervention - Subarachnoid block (SAB) with 40 mg (2 ml) of hyperbaric 20 mg/ml prilocaine and 15 mcg (0.3 ml) fentanyl (50 mcg/ml). | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Prilocaine (hyperbaric 2%), 20mg/ml hyperbaric solution for injection
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Injection
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Dosage and administration details |
Dosing Regimen:
Dose: 40 mg (2 ml)
Supplement: Fentanyl 15 mcg
Route: intrathecal (SAB)
Number of participants (planned and analysed)
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Arm title
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BUPIVICAINE | ||||||||||||||||||
Arm description |
Hyperbaric (heavy) 0.5% Bupivacaine Dose: 10 mg (2 ml) Supplement: Fentanyl 15 mcg Route: Intrathecal (SAB) | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Hyperbaric (heavy) 0.5% Bupivacaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intratracheal use
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Dosage and administration details |
Hyperbaric (heavy) 0.5% Bupivacaine
Dose: 10 mg (2 ml)
Supplement: Fentanyl 15 mcg
Route: Intrathecal (SAB)
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Baseline characteristics reporting groups
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Reporting group title |
PRILOCAINE
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Reporting group description |
Intervention - Subarachnoid block (SAB) with 40 mg (2 ml) of hyperbaric 20 mg/ml prilocaine and 15 mcg (0.3 ml) fentanyl (50 mcg/ml). | ||||||||||||||||||||||||||||||||||||
Reporting group title |
BUPIVICAINE
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Reporting group description |
Hyperbaric (heavy) 0.5% Bupivacaine Dose: 10 mg (2 ml) Supplement: Fentanyl 15 mcg Route: Intrathecal (SAB) | ||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
PRILOCAINE
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Reporting group description |
Intervention - Subarachnoid block (SAB) with 40 mg (2 ml) of hyperbaric 20 mg/ml prilocaine and 15 mcg (0.3 ml) fentanyl (50 mcg/ml). | ||
Reporting group title |
BUPIVICAINE
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Reporting group description |
Hyperbaric (heavy) 0.5% Bupivacaine Dose: 10 mg (2 ml) Supplement: Fentanyl 15 mcg Route: Intrathecal (SAB) | ||
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End point title |
Efficacy [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The time taken in minutes from initiation of subarachnoid block (SAB) until regression of motor block as assessed using the Bromage score of I.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: View Uploaded Report |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Postoperatively and at 24-hour follow-up, the patient will be assessed for any potential adverse events related to the technique or the IMPs.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.1
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Reporting groups
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Reporting group title |
PRILOCAINE
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Reporting group description |
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Reporting group title |
BUPIVICAINE
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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22 Oct 2019 |
AM9 (NSA7)
Study extension & PI change at KCH |
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18 Feb 2020 |
Initial
Protocol / ICF / Poster / GP letter / 24hr phone fup v1 14Oct19
PIS v1 18Oct19
SmPC Bupivacaine (15May15), SmPC Prilotekal (13Dec17)
Revised documents: Protocol v1 24Jan20, ICF v2 09Apr20
PIS v2 19Apr20, Poster v2 09Apr20 |
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13 Sep 2021 |
AM1 (NSA1)
Protocol v1.1 31Aug21
Changes to primary objective, inclusion/exclusion & routine intraoperative procedures etc. |
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07 Feb 2022 |
AM2 (NSA2)
Addition of 2 new sites (The trial to become multi-centre):
Royal Sussex County Hospital (PI: Abigail Medniuk)
Musgrove Park Hospital (PI: Madhavi Keskar)
N.b. this amendment covered the addition of sites only. Study documents reflecting the new multi-centre status of the trial were updated as part of NSA4 |
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15 Mar 2022 |
AM3 (NSA3)
GP letter v2 05Nov21
Change of PI from Kate Cheeseman to Desire Onwochei |
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12 Aug 2022 |
AM4 (NSA4)
Study documents were not updated accordingly at the time of the previous amendment, so this amendment seeks to rectify this. Single to multi-centre trial.
Protocol v1.2 20May22
PIS, ICF, GP letter & 24hr phone fup v3 25May22
Change of PI at Royal Sussex to James Wicker |
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10 Jan 2023 |
AM5 (NSA5)
New Site: KCH
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13 Jul 2023 |
AM7 (NSA6)
Study extension
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19 Aug 2024 |
AM8 (SA1)
Change of CI/PI to Dr Neel Desai
Change of the CI who also serves as the PI, due to upcoming maternity leave starting on 19/04/2024, which includes updates to the protocol, PIS, ICF, Poster and GP letter; Updates to the protocol to align with recent revisions to the pharmacovigilance policy. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
