Ignite Creation Date:
2024-05-06 @ 2:40 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04394533
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2020-05-14
Brief Title:
Hyperbaric Prilocaine Compared With Hyperbaric Bupivacaine in Cervical Cerclage
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRILOCC
Brief Summary:
Patients that have a cervical stitch cervical cerclage require an anaesthetic The most common choice is a spinal block This is an injection in the back that makes the lower half of the body become temporarily numb and weak The key aims when choosing which type of anaesthetic are safety for mother and baby comfort during and after the procedure as well as patient convenience and satisfaction There are two commonly available choices for the drug used in spinal anaesthesia bupivacaine and prilocaine Both have a long history of being safe and effective One difference observed in studies of these drugs used for spinal anaesthetics in other surgeries is that prilocaine is shorter-acting and it therefore takes less time for the return of full strength and sensation of the lower body This means patients are able to leave hospital sooner and are less likely to need a urinary catheter The investigators want to see if these benefits can apply to patients having a cervical stitch too by comparing the recovery of patients having a spinal anaesthetic with one of these two local anaesthetic medications
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 05 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 05 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 005 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 kgm-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
40 mg of hyperbaric 2 prilocaine with 15 mcg of fentanyl intervention and
10 mg of hyperbaric 05 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 05 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 005 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 kgm-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-001548-23 | EUDRACT_NUMBER | None | None |