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

Sponsor

University Hospital, Limoges (Other)

Overall Status

Completed

CT.gov ID

NCT02563821

Collaborator

(none)

Enrollment

Location

Arms

37.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Epidural	Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia Drug: Levobupivacaine Drug: sufentanil Drug: clonidine Device: epidural catheter	Phase 3

Detailed Description

Abstract : The recent technical advances in antenatal diagnosis have led to an increase number of legally induced abortion at the third trimester of pregnancy. Psychological pain is frequently associated to physical pain in these kinds of interventions. So anaesthetists are more and more involved in voluntary termination of pregnancy analgesia.

In France, Patient Controlled Epidural Analgesia (PCEA) with CEI mode is usually used for voluntary termination of pregnancy analgesia. But recent studies have shown that PIEB mode as compared to CEI mode increases maternal satisfaction during labour. This may be attributed to a more extensive spread of epidural solution when delivered as a bolus rather than continuous infusion.

Few trials have been interested in investigating the best mode of PCEA for legally induced abortion analgesia.

This study includes women who undergo voluntary third semester termination of pregnancy. Patients are randomized to PIEB or CEI for pain analgesia. In this randomized, double-blind study, the investigators assess the degree of satisfaction of the patients (primary outcome), the incidence of motor block, total drug consumption and adverse events (secondary outcomes) between the two study groups.

The different values are collected during the intervention on a specific paper for each patient and the degree of satisfaction is reported on this paper just before the patient leaves the birth room (approximatively 2 hours after the expulsion).

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 5, 2015

Actual Primary Completion Date :

Dec 11, 2018

Actual Study Completion Date :

Dec 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PCEA-DC 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
Active Comparator: PCEA-BIP 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

Arm

Intervention/Treatment

Active Comparator: PCEA-DC

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

Active Comparator: PCEA-BIP

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Number and intensity of motor block [procedure]
Incidence of motor block determined by number and intensity
Number of call of the aneshetist for insufficient analgesia [procedure]
Number of call of the aneshetist for insufficient analgesia
Number of doses of complementary manual bolus [procedure]
Number of doses of complementary manual bolus administered
Obstetrical informations [procedure]
time of the intervention, doses of oxytocin and prostin used, instrumental delivery
Numbers of Adverse events [procedure]
Numbers of Adverse events (Pruritus, nausea / vomitings, episodes of arterial low blood pressure)