Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study. (PCEA-IMG)

NCT02563821 | Completed Phase 3

• 1 other identifier: I14032 (PCEA-IMG)
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Background : Recently, delivery of local anaesthetics via Programmed Intermittent Epidural Bolus (PIEB) has been shown to improve labour epidural analgesia compared to delivery via Continuous Epidural Infusion (CEI). Purpose : However, the superiority of PIEB compared to CEI has not been investigated for third trimester voluntary termination of pregnancy. We hypothesized that PIEB administration would result in a better degree of satisfaction of the patients compared with CEI for third trimester legally induced abortion analgesia.

Conditions

Anesthesia, Epidural

Keywords

Termination of pregancy; Third trimester; Programmed intermittent epidural bolus; Continuous epidural infusion; Epidural analgesia; Legally induced abortion

Outcome Measures

Primary Outcomes (1)

• satisfaction visual analog scale (SVAS) measurment

  The degree of satisfaction is assessed using a satisfaction visual analog scale (SVAS) where 0 corresponded to " completely unsatisfied " and 100 to " completely satisfied ".

  procedure

Secondary Outcomes (5)

• Number and intensity of motor block

  procedure

• Number of call of the aneshetist for insufficient analgesia

  procedure

• Number of doses of complementary manual bolus

  procedure

• Obstetrical informations

  procedure

• Numbers of Adverse events

  procedure

Study Arms (2)

PCEA-DC

ACTIVE COMPARATOR

Injection of a 2 mL initial epidural loading dose consisting of a blend (10 mL) of levobupivacaine 20 mg, sufentanil 10 µg to assure the absence of motor block and so exclude intrathecal placement of the epidural catheter. * Injection of the rest of the loading dose (8mL). * In this group the pump is programmed to deliver a continuous infusion at 10 mL /h consisting of levobupivacaine 0,573 mg/mL, sufentanil 0,37 µg/mL, clonidine 1,38 µg/ mL. Additional 5 mL patient-activated boluses will be allowed with a lockout interval of 10 minutes. * If the parturient feels she has inadequate analgesia after having activated the PCEA bolus twice in a thirty minutes period, an additional manual bolus of 6 mL of levobupivacaine 2,5 mg/mL will be administered until the Pain Visual Analog Scale (PVAS) is \< 3/10.

Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia; Drug: Levobupivacaine; Drug: sufentanil; Drug: clonidine; Device: epidural catheter

PCEA-BIP

ACTIVE COMPARATOR

Injection of a 2 mL initial epidural loading dose consisting of a blend (10 mL) of levobupivacaine 20 mg, sufentanil 10 µg to assure the absence of motor block and so exclude intrathecal placement of the epidural catheter. * Injection of the rest of the loadind dose (8 mL) * In this group the pump is programmed to deliver automated mandatory boluses of 5 mL consisting of levobupivacaine 0,573 mg/mL, sufentanil 0,37 µg/mL, clonidine 1,38 µg/mL every 30 minutes. Additional 5 mL patient-activated boluses will be allowed with a lockout interval of 10 minutes. * If the parturient feels she has inadequate analgesia after having activated the PCEA bolus twice in a thirty minutes period, an additional manual bolus of 6 mL of levobupivacaine 2,5 mg/mL will be administered until the Pain Visual Analog Scale (PVAS) is \< 3/10 (0 = no pain and 10 = insufferable pain).

Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia; Drug: Levobupivacaine; Drug: sufentanil; Drug: clonidine; Device: epidural catheter

Interventions

Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia PROCEDURE

PCEA-BIP; PCEA-DC

Levobupivacaine DRUG

PCEA-BIP; PCEA-DC

sufentanil DRUG

PCEA-BIP; PCEA-DC

clonidine DRUG

PCEA-BIP; PCEA-DC

epidural catheter DEVICE

PCEA-BIP; PCEA-DC

Eligibility Criteria

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

You may qualify if:

• age ≥ 18 years
• ASA 1 or 2 (healthy women)
• pregnancy at third trimester
• willingness of voluntary interrupt the pregnancy
• women affiliated to french health social system
• written informed consent from every patient

You may not qualify if:

• contraindications to epidural analgesia
• opioids consumption within the last 24 hours
• patient's unwillingness
• inability to comprehend or comply with the procedure

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Universiy hospital

Limoges, 87000, France

Location

MeSH Terms

Interventions

Levobupivacaine; Sufentanil; Clonidine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazolines; Imidazoles; Azoles

Study Officials

• Patrick SENGES, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: September 30, 2015
• Study Start: November 5, 2015
• Primary Completion: December 11, 2018
• Study Completion: December 11, 2018
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

FR (1)