A Comparison Study of Patient Controlled Epidural Analgesia (PCEA) With and Without Basal Infusion Using Ropivacaine 0,15% and Fentanyl μg/ml for Pain Relief in Labor, Assessment of Efficacy and Maternal Satisfaction.
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      This is a prospective, randomized, double blind study, in which a comparison of patient
      controlled epidural analgesia (PCEA) of continuous background infusion with demand dose and
      demand only, using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor, is being
      investigated. The purpose of the study is the assessment of the efficacy of labor analgesia
      and maternal satisfaction.

      Written informed consent is obtained by all parturients. Non invasive monitor of blood
      pressure, heart rate, SpO2, ECG for the patient and a continuous monitoring of the fetal
      heart rate is being placed.

      The participants are randomized in two groups, both receiving the same drug (ropivacaine
      0,15% and fentanyl 2μg/ml). Group 0 receives demand dose of 5 ml with lockout of 10 minutes.
      Group 1 receives background infusion of 5 ml/h and demand dose of 5 ml with lockout 10
      minutes.

      All parturients have to be instructed to self administration of epidural bolus dose when they
      experience mild to moderate pain. Both parturient and anesthetist who conducts the study and
      treat breakthrough pain, are blind to group assignment.

      After the last suture, total volume of epidural infusions of PCEA, total infused drug of PCEA
      pump, number of delivered PCEA boluses and manual rescue doses are being calculated. Time of
      delivery, mode of delivery, Apgar scores, and overall maternal satisfaction scores, neonate
      pH and Hct of the patient (ABGS), as well as possible need of newborn cardiopulmonary
      resuscitation are also recorded.
    

Detailed description: 
      This is a prospective, randomized, double blind study, in which a comparison of patient
      controlled epidural analgesia (PCEA) of continuous background infusion with demand dose and
      demand only, using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor, is being
      investigated. The purpose of the study is the assessment of the efficacy of labor analgesia
      and maternal satisfaction. Inclusion criteria include primigravidas or secundigravidas, 18 to
      40 years old, ASA I or II, gestational age > 38 weeks, cervical dilatation ≥ 4 cm and request
      for epidural labor analgesia. Exclusion criteria are: patient's refusal to participate to the
      study, allergy to amino amide class of local anesthetics, contraindications to epidural
      analgesia, drug addiction or addiction to alcohol and administration of opioids in the last 3
      hours before the initiation of labor epidural analgesia. Patients with history of clinical
      important cardiovascular, pulmonary, hepatic, neurological, psychiatric, metabolic or kidney
      disease are also excluded from the study.

      After explaining the procedure to the parturient and the written consent is obtained, a
      preload of 500 ml of crystalloids is given intravenously. Non invasive monitor of blood
      pressure, heart rate, SpO2, ECG for the patient and a continuous monitoring of the fetal
      heart rate is being placed.

      The insertion of the epidural catheter is performed at L2-L3, L3-L4 or L4-L5 interspace, in
      the sitting position, with 18G Touhy's needle using the loss of resistance to air technique
      to identify the epidural space. The catheter is inserted 4 cm into the epidural space and
      after aspiration for blood or cerebrospinal fluid is tested with 5 ml of drug containing
      ropivacaine 0,15% and fentanyl 2μg/ml. After 6 minutes and granted that verbal analogue score
      (VAS score) is ≥ 4, the PCEA pump is programmed.

      The participants are randomized in two groups, both receiving the same drug (ropivacaine
      0,15% and fentanyl 2μg/ml). Group 0 receives demand dose of 5 ml with lockout of 10 minutes.
      Group 1 receives background infusion of 5 ml/h and demand dose of 5 ml with lockout 10
      minutes.

      All parturients have to be instructed to self administration of epidural bolus dose when they
      experience mild to moderate pain (before the pain intensity becomes severe). Both parturient
      and anesthetist who conducts the study and treat breakthrough pain, are blind to group
      assignment. Breakthrough pain is defined as the manifestation of severe pain even with
      correct PCEA use, necessitating adjustment of analgesic regimen by the anesthesiologist
      during labor. In this case, the anesthetist controls the function of the epidural catheter
      and administrate a rescue dose of 5 ml of the drug and assess pain after 15 minutes. In case
      of VAS score more than 3 after 30 minutes and administration of two rescue doses, the
      parturient is withdrawn from the study and replaced by another parturient via randomization.

      After the test dose and every 5 minutes for the first hour of labor the following
      parturients' parameters are collected; blood pressure, heart rate, SpO2, VAS score, level of
      sensory block and level of motor block (using the modified Bromage Scale), uterus
      contractions, oxytocin and possible side effects (nausea, vomiting, sedation, itch). Also,
      fetal heart rate is being recorded every five minutes. After the first hour and until the
      beginning of the second stage of labor the above parameters are monitored every 15 minutes,
      and from the second stage to the last suture every 5 minutes. Cervical dilatation is being
      recorded after every cervical examination performed by the obstetric team.

      Maternal hypotension (defined as a systolic blood pressure (SPB) < 100 mmHg or a decrease of
      SBP of more than 20% from the baseline) is treated with left lateral position, administration
      of fluids and intravenous ephedrine (doses of 2,5 mg).

      After the last suture, total volume of epidural infusions of PCEA, total infused drug of PCEA
      pump, number of delivered PCEA boluses and manual rescue doses are being calculated. Time of
      delivery, mode of delivery, Apgar scores, neonate pH and Hct of the patient (ABGS), as well
      as possible need of newborn cardiopulmonary resuscitation are also recorded. The epidural
      catheter is removed when the modified Bromage score is 6/6 and sensation is back to normal.
      At that point the overall maternal satisfaction is assessed.

      The patient is under neurological exam for 24h (every 12 hours according to the protocol of
      our clinic).
    

Intervention name(s): PCEA with basal infusion and demand dose using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor; PCEA without basal infusion (demand only) using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor
Intervention type(s): Other; Other
Intervention MeSH terms: Fentanyl; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PCEA, labor analgesia, background infusion, ropivacaine