Hyperbaric Prilocaine Compared With Hyperbaric Bupivacaine in Cervical Cerclage?

NCT04394533 | Recruiting Phase 4

• 2 other identifiers: 2257032019-001548-23
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Incompetence in Pregnancy as Antepartum Condition

Keywords

cervical incompetence; cervical cerclage; bupivacaine; prilocaine; subarachnoid block

Outcome Measures

Primary Outcomes (1)

• Time from SAB to Bromage score of I

  Difference in time taken for regression of lower limb block between the two groups

  24 hours

Secondary Outcomes (8)

• Time from SAB until loss of cold sensation to ethyl chloride spray at tenth thoracic dermatomal level (T10)

  30 minutes

• Time from SAB until motor block Bromage IV

  30 minutes

• Determine uppermost level of sensory block

  20 minutes

• Degree of motor block

  20 minutes

• Maximum intraoperative Numerical Rating Score (NRS) [0-10]

  1 hour

Study Arms (2)

Prilocaine (Intervention) Group

EXPERIMENTAL

Subarachnoid block (SAB) with 40 mg (2 ml) of hyperbaric 20 mg/ml prilocaine and 15 mcg (0.3 ml) fentanyl (50 mcg/ml)

Drug: Prilocaine (Hyperbaric 2%)

Bupivacaine (Control) Group

ACTIVE COMPARATOR

Subarachnoid block (SAB) with 10 mg (2 ml) of hyperbaric 5 mg/ml bupivacaine and 15 mcg (0.3 ml) fentanyl (50 mcg/ml)

Drug: Bupivacaine (Hyperbaric 0.5%)

Interventions

Prilocaine (Hyperbaric 2%) DRUG

2 ml hyperbaric prilocaine

Also known as: Hyperbaric prilocaine

Prilocaine (Intervention) Group

Bupivacaine (Hyperbaric 0.5%) DRUG

2 ml hyperbaric bupivacaine

Also known as: Heavy bupivacaine 0.5%, heavy marcaine 0.5%

Bupivacaine (Control) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy (ASA score 2 or 3) pregnant women presenting for elective cervical cerclage under SAB.
• Age \> 18 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Obstetric Anaesthetists' Association United Kingdom: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7RT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Incompetence

Interventions

Prilocaine; Bupivacaine

Condition Hierarchy (Ancestors)

Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Pregnancy Complications; Genital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Desire Onwochei, MBBS

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Desire Onwochei, MBBS

CONTACT

02071880644; desire.onwochei@gstt.nhs.uk

Gill Arbane

CONTACT

020 7188 8070; gill.arbane@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, parallel group, double-blind, randomised, controlled, superiority trial

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: August 27, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)