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Comparison of different doses of bupivacaine in labor spinal analgesia

Comparison of the analgesic effects of one and two miligram bupivacaine added to intrathecal sufentanil on labor analgesia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201701168768N5
Enrollment
40
Registered
2017-02-07
Start date
2017-01-29
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

labor analgesia. Complication of anaesthesia during labour and delivery, unspecified

Interventions

Intervention 1: Intervention 1: ?Spinal injection consisted 5 microgram sufentanil with 1 mg of bupivacaine from the L4-L5 or L3-L4 interspace with the patient in the sitting position. Intervention
Treatment - Drugs
Intervention 1: ?Spinal injection consisted 5 microgram sufentanil with 1 mg of bupivacaine from the L4-L5 or L3-L4 interspace with the patient in the sitting position.
Intervention 2: Spinal injection consisted 5 microgram sufentanil with 2 mg of bupivacaine from the L4-L5 or L3-L4 interspace with the patient in the sitting position.

Sponsors

Vice chancellor for Research and Technology, Hamadan University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Inclusion criteria: ASA 1 primigravid singletone parturients with gestational age (36-40 wk) in active phase of labor (cervix dilation 4-6 cm) Exclusion criteria: Use of analgesic or opioids in recent 12 hours; chronic hypertension; preeclampsia; gestational diabetes; allergy to drugs; cardiovascular disease; coagulopathy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Onset of analgesia. Timepoint: every 5 minutes after spinal injection. Method of measurement: Time from spinal injection until the relief of labor pain in the first 15 min such that the subject did not request rescue medication.(pain VAS<4).;Duration of analgesia. Timepoint: every 15 minutes after spinal injection. Method of measurement: Time from spinal injection until the end of spinal analgesia.(minute).

Secondary

MeasureTime frame
Pruritus. Timepoint: every 15 minutes after spinal injection until the end of spinal analgesia. Method of measurement: VAS for pruritus (0-10).;Nausea and vomiting. Timepoint: every 15 minutes after spinal injection until the end of spinal analgesia. Method of measurement: yes/no question from patient.;Motor bockade. Timepoint: every 15 minutes after spinal injection. Method of measurement: Bromage Scale (1=no motor block--ability to raise extended leg against gravity; 2 = inability to raise extended leg, able to bend knee; 3 = inability to bend knee, able to flex ankle; and 4 = complete motor block) were assessed at the 3 levels.;Neonatal Apgar score. Timepoint: 1 and 5 minutes after birth. Method of measurement: Apgar scale.;Sensory level to cold and pinprick. Timepoint: 15 minutes after spinal injection. Method of measurement: question from patient in response to cold and pinprick (dermatomal level).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahshid Nikooseresht M.D

Hamadan University of Medical Sciences

nikooseresht@umsha.ac.ir+98 81 3264 0050

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026