Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Termination of Pregnancy Analgesia

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

This study included women who underwent voluntary second trimester termination of pregnancy. Patients were randomized to programmed intermittent epidural anesthetic bolus or continuous epidural infusion for pain analgesia. In this randomized, double-blind study, the investigators assess the incidence of motor block (primary outcome), degree of satisfaction of the patients, total levobupivacaine and sufentanil consumption and adverse events (secondary outcomes) between the two study groups.

Study Overview

• Status: Completed
• Conditions: Medical; Abortion, Fetus
• Intervention / Treatment: Procedure: Programmed Intermittent Epidural Bolus; Procedure: Procedure of interruption of pregnancy; Drug: Drug used for analgesia procedures; Device: Pump for programmed intermittent bolus.; Drug: Drug used for termination of pregnancy procedure.; Procedure: Continuous Epidural Infusion; Device: Pump for continuous epidural infusion.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ligury
    • Genoa, Ligury, Italy, 16132
      • Department of Obstetrics and Gynecology, San Martino Hospital and National Institute for Cancer Research, University of Genoa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• age ≥ 18 years
• pregnancy at second trimester
• willingness of voluntary interrupt the pregnancy
• comprehension of Italian Language
• baseline pain score ≥ 30 on a 100-mm visual analog pain scale (VAPS)

Exclusion Criteria:

• contraindication to epidural analgesia and to narcotics
• history of drug abuse or chronic use
• maternal disease (such as severe asthma, cardiac, liver or kidney disease)
• inability to comprehend or comply with the analgesia pain management procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Programmed Intermittent Epidural Bolus	Procedure: Programmed Intermittent Epidural Bolus; An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered.; Procedure: Procedure of interruption of pregnancy; Patients were administered 1 mg of gemeprost pessaries (Cervidil®, Merck Serono SPA, Roma, Italy) in the posterior fornix of the vagina every 3 hours up to 5 doses. If the expulsion of the fetus did not occur, the therapeutic regimen was repeated after 24 hours from the initiation of the treatment. Induction-to-abortion time (hours) was considered the period of time comprised between the first gemeprost pessary administration and fetal expulsion. Failure of induction of abortion was defined as women undelivered after two completed cycles (48h).The evacuation of the uterus under general anesthesia was performed if ultrasonography showed retained productions of conception.; Drug: Drug used for analgesia procedures; Levobupivacaine (Chirocaine®, Abbott, Chicago, IL, USA) and sufentanil(Fentatienil®, Angelini, Rome, Italy) were administered in both study groups according to the regimen of each intervention arm (Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion).; Other Names: Levobupivacaine: Chirocaine®, Abbott, Chicago, IL, USA.; Sufentanil: Fentatienil®, Angelini, Rome, Italy.; Device: Pump for programmed intermittent bolus.; Pump administering programmed intermittent epidural bolus for the maintenance of analgesia was used.; Other Names: Pump: Gemstar®; Hospira, Lake Forest, USA.; Drug: Drug used for termination of pregnancy procedure.; Gemeprost pessaries.; Other Names: Gemeprost pessaries: Cervidil®, Merck Serono SPA, Rome, Italy.
Active Comparator: Continuous Epidural Infusion	Procedure: Procedure of interruption of pregnancy; Patients were administered 1 mg of gemeprost pessaries (Cervidil®, Merck Serono SPA, Roma, Italy) in the posterior fornix of the vagina every 3 hours up to 5 doses. If the expulsion of the fetus did not occur, the therapeutic regimen was repeated after 24 hours from the initiation of the treatment. Induction-to-abortion time (hours) was considered the period of time comprised between the first gemeprost pessary administration and fetal expulsion. Failure of induction of abortion was defined as women undelivered after two completed cycles (48h).The evacuation of the uterus under general anesthesia was performed if ultrasonography showed retained productions of conception.; Drug: Drug used for analgesia procedures; Levobupivacaine (Chirocaine®, Abbott, Chicago, IL, USA) and sufentanil(Fentatienil®, Angelini, Rome, Italy) were administered in both study groups according to the regimen of each intervention arm (Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion).; Other Names: Levobupivacaine: Chirocaine®, Abbott, Chicago, IL, USA.; Sufentanil: Fentatienil®, Angelini, Rome, Italy.; Drug: Drug used for termination of pregnancy procedure.; Gemeprost pessaries.; Other Names: Gemeprost pessaries: Cervidil®, Merck Serono SPA, Rome, Italy.; Procedure: Continuous Epidural Infusion; An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered.; Device: Pump for continuous epidural infusion.; Pump administering continuous epidural infusion for the maintenance of analgesia was used.; Other Names: Pump: Gemstar®; Hospira, Lake Forest, USA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Motor Block	The assessment of the degree of motor block was performed in the right and left lower extremities using the Breen modified Bromage score: 1 = complete block (unable to move feet or knees), 2 = almost complete block (able to move feet only), 3 = partial block (just able to move knees), 4 = detectable weakness of hip flexion while supine (between scores 3 and 5), 5 = no detectable weakness of hip flexion while supine (full flexion of knees), and 6 = able to stand and to perform partial knee bend. Patients with a Bromage score < 6 were considered to have motor block.	Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Satisfaction of the Patients With the Analgesia Procedure	At discharge from the hospital, patients were requested to answer the following question "Taking into consideration the variations in pain symptoms, as well as the adverse events experienced, if any, how would you define the grade of satisfaction with your analgesic treatment?" The grade of satisfaction was assessed using a visual analog scale (VAS) where 0 corresponded to "completely unsatisfied" and 100 to "completely satisfied".	At discharge from the hospital (up to 72 hours from starting of the procedure).
Total Levobupivacaine Consumption		At the moment of fetal expulsion (up to 66 hours from starting of the procedure).
Total Sufentanil Consumption.		During the whole analgesia procedure (assessed between the starting of the procedure until 66 hours).

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Investigators: Study Director: Simone Ferrero, PhD, Università degli Studi di Genova; Principal Investigator: Umberto Leone Roberti Maggiore, MD, Università degli Studi di Genova

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 22, 2013

Study Record Updates

• Last Update Posted (Estimate): October 28, 2013
• Last Update Submitted That Met QC Criteria: August 19, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Epidural analgesia; Programmed intermittent epidural bolus; Second trimester; Termination of pregnancy; Continuous epidural infusion; Legally Induced Abortion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Levobupivacaine; Sufentanil; Gemeprost
• Other Study ID Numbers: SCUL 4022