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NCT Number: NCT01860521

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

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.

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Key information

Conditions

Medical; Abortion, Fetus

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Genoa, Ligury, 16132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Programmed Intermittent Epidural Bolus

Procedure

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.

Continuous Epidural Infusion

Procedure

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.

Procedure of interruption of pregnancy

Procedure

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 used for analgesia procedures

Drug

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.

Pump for programmed intermittent bolus.

Device

Pump administering programmed intermittent epidural bolus for the maintenance of analgesia was used.

Other names: Pump: Gemstar®; Hospira, Lake Forest, USA.

Pump for continuous epidural infusion.

Device

Pump administering continuous epidural infusion for the maintenance of analgesia was used.

Other names: Pump: Gemstar®; Hospira, Lake Forest, USA.

Drug used for termination of pregnancy procedure.

Drug

Gemeprost pessaries.

Other names: Gemeprost pessaries: Cervidil®, Merck Serono SPA, Rome, Italy.

Primary outcomes

  1. Incidence of Motor Block

    Time frame: Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).

    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.

Secondary outcomes

  1. Degree of Satisfaction of the Patients With the Analgesia Procedure

    Time frame: At discharge from the hospital (up to 72 hours from starting of the 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".

  2. Total Levobupivacaine Consumption

    Time frame: At the moment of fetal expulsion (up to 66 hours from starting of the procedure).

  3. Total Sufentanil Consumption.

    Time frame: During the whole analgesia procedure (assessed between the starting of the procedure until 66 hours).

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 22, 2013
Registry last updated
Oct 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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