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

NCT03806673 | Completed Phase 4

• 1 other identifier: Ain Shams Un
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Incidence; Unilateral; Epidural Block

Keywords

unilateral, ,; epidural block; repeated epidural

Outcome Measures

Primary Outcomes (1)

• sensation

  by cold skin test

  30 minutes after injection of local anesthetic

Study Arms (2)

primipara

ACTIVE COMPARATOR

primipara subjected to their first epidural block

Drug: marcaine

multipara

ACTIVE COMPARATOR

multipara subjected to their repeated epidural block.

Drug: marcaine

Interventions

marcaine DRUG

epidural block

multipara; primipara

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy ASA II female patients,
• years of age,
• scheduled for normal vaginal delivery.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ramymahrose

Cairo, 02, Egypt

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: double blinded randomized

Study Record Dates

• First Submitted: January 12, 2019
• First Posted: January 16, 2019
• Study Start: February 5, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 11, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)