- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04394533
Hyperbaric Prilocaine Compared With Hyperbaric Bupivacaine in Cervical Cerclage? (PRILOCC)
Does Subarachnoid Administration of Hyperbaric Prilocaine Produce an Improved Recovery From Anaesthesia When Compared With Hyperbaric Bupivacaine When Used to Make Cervical Cerclage Easier in Pregnant Women at Risk of Pre-term Loss?
Study Overview
Status
Intervention / Treatment
Detailed Description
Cervical incompetence is defined as the inability to sustain a pregnancy to full term. It is characterized by recurrent second-trimester pregnancy losses. Cervical cerclage is a procedure that is commonly carried out in order to prevent pre-term loss in at-risk pregnancies. The major challenge of performing this as a day case procedure is achieving adequate anaesthesia for comfortable performance of the cerclage whilst providing adequate regression of motor and sensory blocks to allow ambulation and bladder control within an appropriate timescale. Spinal anaesthesia, or subarachnoid block (SAB), is commonly employed to facilitate a wide variety of pelvic and lower limb surgeries. In the United Kingdom, the commonly administered subarachnoid agents are bupivacaine, prilocaine and, until recent decades, lidocaine. The duration of action of bupivacaine makes it less well suited to day surgery as it is often difficult to reach discharge criteria within a convenient time frame. The investigators aim to examine the recovery profiles of two equipotent doses of hyperbaric prilocaine and bupivacaine. Given the evidence, the survey of practice in other centres and the commonly used doses at this institution the following regimens will be compared:
- 40 mg of hyperbaric 2% prilocaine with 15 mcg of fentanyl (intervention) and
- 10 mg of hyperbaric 0.5% bupivacaine with 15 mcg of fentanyl (comparator).
Primary Objective:
This study aims to determine if a difference exists between the time required for regression of motor block between two commonly used and equipotent doses of subarachnoid hyperbaric prilocaine and bupivacaine.
- The hypothesis is that SAB with hyperbaric 2% prilocaine will result in a clinically significant reduction in time taken for regression of motor blockade, as determined by achieving a Bromage score* of I, when compared to an equipotent dose of hyperbaric bupivacaine when used to facilitate cervical cerclage in pregnant women in the second trimester of pregnancy.
- The null hypothesis is that no clinically significant difference exists while the alternative hypothesis is that such a difference truly exists.
Secondary Objectives:
- To compare the intraoperative characteristics of the subarachnoid block and quality of intraoperative anaesthesia in the two groups.
- To compare the recovery profiles in the two groups
- To compare the incidence of complications in the two groups
- To compare the satisfaction of the participants in each group This is a prospective, single centre, parallel group, double-blind, randomised, controlled, superiority trial. The sample size will consist of 135 patients having elective cervical cerclage, under SAB, due to cervical incompetence.
Sample Size Calculation The primary outcome measurement is the comparison of the difference in time taken for regression of lower limb motor block with hyperbaric (heavy) 2% prilocaine compared to hyperbaric (heavy) 0.5% bupivacaine. Assuming, based on pilot data, that the time to regression of motor block has a standard deviation of up to 60 mins; complete data on 128 participants (64 to each arm) would give 80% power to detect a plausible and clinically important 30-min difference between groups at the 0.05 significance level. To allow for up to 5% dropout, the study will recruit 135 women.
Random allocation to groups will be achieved using "Castor" randomisation software. The sequence will have been previously determined, prior to recruitment, using computer software, by random permuted blocks. Subsequently, the subjects who give written informed consent will be randomly assigned a unique 3-digit subject number. The subject number together uniquely identifies every subject eligible for the study. Randomisation will take place on the day of surgery by a non-operating healthcare professional who will randomise according to the "Castor" software. If code breaking is necessary, this will be done by pharmacy. As soon as 128 evaluable subjects have been included in the study, recruitment will be stopped.
Analysis After checking for normality by standard diagnostic plots, a comparison between the groups will be made using multiple regression with a dummy variable for treatment arm. A correction will be made for unequal variance using the robust standard errors. Adjustment will be made for maternal BMI and height, as these are known to be related to anaesthetic effect.
No power calculation has been carried out for the secondary outcomes, and no priority is made between them. Continuous measures, including the patient satisfaction score, will be analysed as described above for the primary outcome. Binary measures will be expressed as percentages, and compared by means of risk ratios, using binary regression with a log link, adjusted for BMI and height, as described above.
Subgroup analyses: A comparison will be made between normal weight and obese women (BMI over 30 kg.m-2); and between women above and below 165 cm in height, using an interaction test to check for a difference in treatment effect.
No interim analysis is planned.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Desire Onwochei, MBBS
- Phone Number: 02071880644
- Email: desire.onwochei@gstt.nhs.uk
Study Contact Backup
- Name: Gill Arbane
- Phone Number: 020 7188 8070
- Email: gill.arbane@gstt.nhs.uk
Study Locations
-
-
-
London, United Kingdom, SE1 7RT
- Recruiting
- Guy'S and St Thomas' Nhs Foundation Trust
-
Contact:
- Gill Arbane
- Phone Number: 0207 188 8070
- Email: gill.arbane@gstt.nhs.uk
-
Contact:
- Desire Onwochei, MBBS
- Phone Number: 0207 188 80644
- Email: desire.onwochei@gstt.nhs.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy (ASA score 2 or 3) pregnant women presenting for elective cervical cerclage under SAB.
- Age > 18 years
Exclusion Criteria:
- Inability to read or understand the patient information sheet (PIS)
- Age < 18 years
- Unable or unwilling to consent to participation
- non-elective procedure
- serious co-morbidities (ASA score 4 or above)
- any contraindication to SAB, e.g. local or generalised infection, active central nervous system disease, coagulation disorders or anti-coagulant medication
- any history of allergic reaction to any of the medications in the protocol
- concomitant use of class III anti-arrhythmics (sulfonamides, antimalarials, sodium nitroprussate, nitroglycerin, other local anaesthetics)
- any contraindication to the use of bupivacaine or prilocaine as listed in the SmPCs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prilocaine (Intervention) Group
Subarachnoid block (SAB) with 40 mg (2 ml) of hyperbaric 20 mg/ml prilocaine and 15 mcg (0.3 ml) fentanyl (50 mcg/ml)
|
2 ml hyperbaric prilocaine
Other Names:
|
Active Comparator: Bupivacaine (Control) Group
Subarachnoid block (SAB) with 10 mg (2 ml) of hyperbaric 5 mg/ml bupivacaine and 15 mcg (0.3 ml) fentanyl (50 mcg/ml)
|
2 ml hyperbaric bupivacaine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time from SAB to Bromage score of I
Time Frame: 24 hours
|
Difference in time taken for regression of lower limb block between the two groups
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time from SAB until loss of cold sensation to ethyl chloride spray at tenth thoracic dermatomal level (T10)
Time Frame: 30 minutes
|
Difference in time (minutes) for loss of cold sensation at tenth thoracic dermatomal level (T10)
|
30 minutes
|
Time from SAB until motor block Bromage IV
Time Frame: 30 minutes
|
Difference in time take for complete motor block to occur
|
30 minutes
|
Determine uppermost level of sensory block
Time Frame: 20 minutes
|
Determine uppermost (cephalad) dermatomal level of sensory block as measured by loss of cold sensation to ethyl chloride spray at 20 minutes (mean).
|
20 minutes
|
Degree of motor block
Time Frame: 20 minutes
|
Mean degree of motor block as assessed on the Bromage scale at 20 minutes (from I-IV)
|
20 minutes
|
Maximum intraoperative Numerical Rating Score (NRS) [0-10]
Time Frame: 1 hour
|
Mean pain score on the NRS (from 0-10) of maximal discomfort experienced during the procedure
|
1 hour
|
Time from SAB to ambulation
Time Frame: 24 hours
|
Mean time in minutes from SAB to ambulation
|
24 hours
|
Time from SAB to micturition
Time Frame: 24 hours
|
Mean time in minutes from SAB to micturition
|
24 hours
|
Time from SAB to discharge
Time Frame: 24 hours
|
Mean time in minutes from SAB to discharge
|
24 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Desire Onwochei, MBBS, Guy'S and St Thomas' Nhs Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Uterine Cervical Diseases
- Uterine Diseases
- Pregnancy Complications
- Abortion, Habitual
- Abortion, Spontaneous
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Incompetence
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Prilocaine
- Bupivacaine
Other Study ID Numbers
- 225703
- 2019-001548-23 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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