Analgesic Efficacy of Two Concentrations of Bupivacaine in Women in Labor

NCT02244086 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2016-05-27

No results posted yet for this study

Summary

Abstract.

Epidural analgesia is the most safe and effective for the treatment of pain of childbirth method. Epidural Bupivacaine provided excellent analgesia for labor and remains the most widely used local anesthetic in obstetric anesthesia.

Objective: To evaluate the analgesic efficacy of two concentrations of bupivacaine in women in labor.

Methods: 114 patients were included in labor with term pregnancy. Were grouped randomly into two groups: patients who received bupivacaine 0.125 % (Group A) and 0.25% bupivacaine (group B). Patients in group A received 10 ml of 0.125% bupivacaine bolus. The patients in group B received 10 ml. Bupivacaine 0.25% bolus. Pain intensity according to VAS, blood pressure, heart rate, respiratory rate, degree of motor block was assessed using the Bromage scale at different periods of time.

Results: Demographic characteristics and parity were compared, no statistically significant differences. By comparing the values of the VAS measure 0, 15, 30, 60 and 90 minutes into statistically significant differences in favor of the group with 0.25% Bupivacaine with decreased pain perception after 30 minutes, p-value found 0.02. No differences in arterial pressure, heart rate and respiratory rate were found between the two groups.

Conclusion: The concentration of 0.25% Bupivacaine has greater analgesic efficacy compared with 0.125% bupivacaine.

Conditions

  • Obstetric Pain

Interventions

DRUG

bupivacaine

At the beginning of the work of effective labor maneuver randomly be allocated ( using sealed envelopes) and an outsider to the study prepared the dosage to bupivacaine 0.125% or 0.25% to be administered by epidural catheter for an anesthesiologist to disown the concentration employed. It is measured vital signs, and visual analogue scale dilatation in minutes 0,15,30,60 and 90 after being applied analgesia.

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV
  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Principal Investigators

  • Maria V Jiménez Báez, PhD · Instituto Mexicano del Seguro Social

  • Ricardo Rodríguez Ramon, Dr. · Instituto Mexicano del Seguro Social

  • Ilse C Iparrea Ramos, Dr. · Instituto Mexicano del Seguro Social

  • Horacio Márquez González, MSc · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Mexico

Study Locations

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Read the full study record

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View NCT02244086 on ClinicalTrials.gov