Analgesic Efficacy of Two Concentrations of Bupivacaine in Women in Labor

NCT02244086 | Completed Phase 4 DMC

• 1 other identifier: R-2013-2301-21
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

obstetric pain, bupivacaine, analgesic efficacy

Outcome Measures

Primary Outcomes (1)

• Decrease in Pain with Visual Analogue Scale (VAS)

  The visual analogue scale will be measured at the following times: at the time of analgesia, 15 minutes, 30 minutes, 60 minutes and 90 minutes. It will ask the mother after spending the uterine contraction and will show cards that visually validated measure the pain reported by the patient.

  0, 15,30, 60 and 90 minutes

Secondary Outcomes (3)

• cardiac frequency

  during labor

• Respiratory rate

  during labor

• Blood pref Blood pressure

  during labor

Study Arms (2)

bupivacaine 0.125%

NO INTERVENTION

administrate bupivacaine at 0.125% during initiation of effective labor work

bupivacaine 0.25%

EXPERIMENTAL

Administrate bupivacaine at 0.25% during initiation of effective labor work One of the researchers selected from a randomized list containing pages in both groups with numbers ranging from 0001 to 0110 with 55 pages for each group and these selected folios prepared in sterile form and start the day in the morning, the amount of 10 10 ml syringes with foil for each mixture. The remaining samples were discarded if 10 analgesics are not achieved during the day, and the day new preparations were made.

Drug: bupivacaine

Interventions

bupivacaine DRUG

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.

Also known as: Bupivacaine 0.125%, Bupivacaine 0.25%

bupivacaine 0.25%

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women with normal pregnancy at term, with active labor, the American Society of Anesthesiologists physical (ASA) st atus I or II.

You may not qualify if:

• Patients with problems of language barriers, allergic to local anesthetics, which have been submitted in the last quarter of any of the following situations: pregnancy induced, placenta previa, abnormal fetal variety of presentation, cephalopelvic disproportion, uterine hypertonic hypertensive disease ; Obstetric emergencies such as severe preeclampsia, abruptio placenta detachment, acute fetal distress. Alterations in the anatomy of the spine or previous surgeries that prevent or restrict the conduct of epidural analgesia.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

Hospital General Regional número 17, Instituto Mexicano del Seguro Social.

Cancún, Quintana Roo, Mexico

Location

Related Publications (1)

• Rodríguez-Ramón R, Márquez-González H, Jiménez-Báez MV, Iparrea-Ramos IC. Analgesic efficacy of two concentrations of bupivacaine in women in labor: Randomized, controlled, triple blind clinical trial. Colombian Journal of Anesthesiology, Volume 43, Issue 3, July-September 2015, Pages 179-185

  RESULT

MeSH Terms

Conditions

Labor Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Maria V Jiménez Báez, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

• Ricardo Rodríguez Ramon, Dr.

  Instituto Mexicano del Seguro Social

  STUDY DIRECTOR

• Ilse C Iparrea Ramos, Dr.

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

• Horacio Márquez González, MSc

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador Responsable. Coordinador Auxiliar Médico de Investigación en Salud

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 18, 2014
• Study Start: June 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

ME (1)