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Is There a Relation Between Unilateral Epidural Block and Repeated Epidural Anesthesia?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03806673
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
RAMY AHMED, Ain Shams University

Brief Summary:

epidural block is today the most common method of pain relief during labor. With increased use of epidural analgesia, many women are found in the second or third pregnancy and require repeated epidural analgesia. But there was a higher incidence of unilateral blockade among women receiving their repeated epidural which causes patient unsatisfaction.

Objectives: Examination of the performance and outcome of women receiving their first versus repeated epidural block.

Patients and methods: The study included 140 American Society of Anesthesiologists (ASA) Physical Status II patients (age range 20 to 40 years) and scheduled for normal vaginal delivery. The patients were divided randomly into two equal groups. Group (A) in which 70 women primipara subjected to their first epidural block while group (B) in which 70 women multipara subjected to their repeated epidural block. For each patient, the following data were collected: demographic data, details of labor (gestation, cervical dilatation), visual analogue scale (VAS) before the epidural and 30 minutes after injection of local anesthetic and incidence of unilateral block.


Condition or disease Intervention/treatment Phase
Incidence Unilateral Epidural Block Drug: marcaine Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double blinded randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Is There a Relation Between Unilateral Epidural Block and Repeated Epidural Anesthesia?
Actual Study Start Date : February 5, 2018
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 11, 2018

Arm Intervention/treatment
Active Comparator: primipara
primipara subjected to their first epidural block
Drug: marcaine
epidural block

Active Comparator: multipara
multipara subjected to their repeated epidural block.
Drug: marcaine
epidural block




Primary Outcome Measures :
  1. sensation [ Time Frame: 30 minutes after injection of local anesthetic ]
    by cold skin test



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy ASA II female patients,

    • 20-40 years of age,
    • scheduled for normal vaginal delivery.
    • Exclusion Criteria:
  • - Any physical reason for difficult epidural performance e.g.: morbid obesity, or scoliosis,
  • Severe hypertension,
  • Congestive heart failure,
  • Coagulopathy,
  • Significant hepatic or renal disease,
  • Or withdrawal of consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806673


Locations
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Egypt
Ramymahrose
Cairo, Egypt, 02
Sponsors and Collaborators
Ain Shams University

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Responsible Party: RAMY AHMED, lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT03806673    
Other Study ID Numbers: Ain Shams Un
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RAMY AHMED, Ain Shams University:
unilateral, ,
epidural block
repeated epidural
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents