Intrathecal Analgesia for Normal Labour

NCT04221568 | Unknown Phase 1

• 1 other identifier: Analgesia in normal labour
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary outcome: Compare the duration of analgesia. Secondary outcome: analgesic potency of bupivacaine and fentanyl versus levobupivacaine and fentanyl.

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• Compare the duration of analgesia of bupivacaine and fentanyl versus levobupivacaine and fentanyl.

  Defined as the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed.

  From2 to 8 hours. It is the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed by Visual Analog Scale for Pain (VAS Pain)

Secondary Outcomes (1)

• Analgesic potency of bupivacaine and fentanyl versus levobupivacaine and fentanyl.

  From2-8 hours. It is the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed by Visual Analog Scale for Pain (VAS Pain)

Interventions

Bupivacaine-fentanyl DRUG

local anathetic\&analgesic drugs

levobupivacaine-fentanyl DRUG

local anathetic\&analgesic drugs

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• singleton pregnancies
• vertex presentation who will be in the active phase of labour with a cervical dilatation \>4cm
• normal fetal heart rate.

You may not qualify if:

• Parturients with systemic diseases 2-Suspected cesarian section which include, in order of frequency, labor dystocia, abnormal or indeterminate (formerly, nonreassuring) fetal heart rate tracing, fetal malpresentation, multiple gestation, and suspected fetal macrosomia.
• Fetus with known or suspected congenital abnormalities, and 4-Administration of parentral or oral analgesics before initiation of neuraxial analgesia will be excluded from the study.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Brose D. [Pathology of the orofacial systems]. Zahntechnik (Berl). 1975 May;16(5):224-7. No abstract available. German.

  PMID: 1077683 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• hamdy abbas

  Assiut University

  STUDY DIRECTOR

• wesam nashat

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

peter elesha

CONTACT

+201207674699; peter_hero14@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: multiparous parturients at term pregnancy (American society of anathesiologist physical status grade II)

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: January 9, 2020
• Study Start: March 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: January 9, 2020

Record last verified: 2020-01