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

January 12, 2019 updated by: RAMY AHMED, Ain Shams University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was performed after obtaining approval from the ethical committee of the Ain Shams University. Sample of 140 healthy ASA II female patients, 20-40 years of age, scheduled for normal vaginal delivery. Patients were randomly allocated by computer-generated random number list into two study groups of 70 patients each.

Group (A) in which 70 primipara women subjected to their first epidural block while group (B) in which 70 multipara women subjected to their repeated epidural block. The study was carried out between January 2018 and March 2018.

Patients were excluded for:

  • 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. All patients in this study were subjected to a detailed pre-anesthetic evaluation. All basic investigations according to the hospital protocol (e.g. serum hemoglobin, platelet count, coagulation profile) were checked.

The patient's demographic data, details of labor (gestation, cervical dilatation), details of epidural insertion were recorded by the anesthetist performing the epidural.

The patient was asked to mark a visual analogue scale (VAS) (figure 1) before the epidural and 30 minutes after injection of local anesthetic. Also incidence of unilateral epidural block is reported 30 minutes after injection of local anesthetic.

Figure (1): Visual analog scale 2.2 Anesthetic technique On arrival to operation room; 18 g cannula was inserted then 500 ml of Ringer solution was infused while performing the epidural.

Basic monitors including automatic blood pressure measurements, five lead ECG monitor, and finger pulse oximetry were applied to all patients.

A standard procedure was followed for epidural insertion and establishment of block. With the patient in the sitting position the midline approach was used using 16-g Tuohy needle and the epidural space was identified by loss of resistance to air, as is our routine practice.

Once the epidural space was reached, Bupivacaine 0.25% plain, was given in three 5 ml increments at five-minute intervals, the first administered through the needle while the patient is in sitting position, and then through the catheter with the patient in supine position.

Multi-orifice catheters were inserted and fixed to a standard 4 cm extra to the distance between the skin and epidural space. At the time of insertion of the catheter the patient was asked to report any pain or tingling experienced.

The operator recorded the ease of insertion of the catheter (difficult or easy) and the occurrence of blood in needle or catheter. Epidurals were performed by the same anesthetists.

At 30 min after injection of bupivacaine, the second VAS was completed and the level of blockade checked by cold sensation test. If an inadequate level was noted (less than T10), the pain score remained high or increased, or the patient complained of poor pain relief she was asked to describe the site and type of pain experienced.

A unilateral block was defined as the description by the patient of worse pain on one side than the other, or pain on one side only, combined with either a 30-min pain score minimally changed or increased from time zero or a low level of blockade on the painful side, or both. If unilateral or inadequate block occurred the catheter was withdrawn 0.5-1 cm and a further 5 ml bupivacaine 0.25% was administered with the patient lying on the unblocked side. If the block was still inadequate, epidural fentanyl 50 microgram was given and if still inadequate the catheter was removed and a second epidural catheter inserted in another interspace.

The number of repeat injections of bupivacaine and length of time between epidural insertion and delivery were noted, as well details of previous epidurals in the multiparous women.

Sample size estimation:

To show a difference in the incidence of unilateral block between the two groups with p-value < 0.05 and power 80%, we needed at least 60 patients per group.

Statistical analysis:

Analysis of data was done by IBM computer using SPSS (statistical program for social science, version 16) as follows:

  • Description of quantitative variables as mean ± SD.
  • Description of quantitative variables as number and percentage. Statistical analysis was performed using statistical tests included Student's t-test, Chi square test and table analysis. P value <0.05 is considered significant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Ramymahrose

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
sensation
Time Frame: 30 minutes after injection of local anesthetic
by cold skin test
30 minutes after injection of local anesthetic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ain Shams Un

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epidural Block

Clinical Trials on marcaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings