Regional Blocks of Gynecological Surgeries

August 27, 2021 updated by: Reham Ali Abdelhaleem Abdelrahman, Cairo University

Comparison of Dural Puncture Epidural Technique Versus Conventional Epidural Technique for Adequate Anesthesia During Vaginal Surgeries

This study will be conducted on 273 patients of ASA grade I and II aged from 25 to 55 years and presented for elective vaginal surgeries such as vaginal hysterectomy, repair of prolapse Patients will be divided into three equal groups; group A control group for conventional epidural technique(n=91), group B for dural puncture epidural with 27G pencil point Whitacre spinal needle (n=91) and group C for dural puncture epidural with 25G pencil point Whitacre spinal needle(n=91). Randomization will be done using computer generated number and concealed using sequentially numbered sealed opaque envelope.

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.

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.
273

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.
  • Not Applicable

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, 11562
        • Department of Anesthesia, Surgical ICU, and Pain Management
      • Cairo, Egypt, 11562
        • Reham Ali Abdelrahman

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

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA I and II
  • Height(150-170 cm)

Exclusion Criteria:

  • patient refusal
  • hypersensitivity to local anesthetic drugs
  • bleeding disorders and coagulopathy(platelets count less than 80000,INR less than 1.5 or therapeutic dose of anticoagulant).

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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.
Experimental: Conventional Epidural Technique
Procedure: Standard Lumbar Epidural Block using Touhy Epidural Needle (18G) at L4-5 inter-space and Epidural Catheter (20G) was inserted then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
Procedure: 25G Dural Puncture Epidural Technique
25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
Procedure: 27G Dural Puncture Epidural Technique
27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
Active Comparator: Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle
Procedure: 25G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
Procedure: 27G Dural Puncture Epidural Technique
27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
Procedure: Standard Lumbar Epidural Technique
Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
Active Comparator: Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle
Procedure: 27G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
Procedure: 25G Dural Puncture Epidural Technique
25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
Procedure: Standard Lumbar Epidural Technique
Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.

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
incidence of bilateral sacral blockade
Time Frame: Up to 30 minutes after local anesthetic injection
Sensory blockade was evaluated using a non-traumatic pinprick stimulus starting at the S2 dermatome and moving in a caudad direction (measured every 2 minutes)
Up to 30 minutes after local anesthetic injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Onset of sensory blockade
Time Frame: Up to 30 minutes after local anesthetic injection
Up to 30 minutes after local anesthetic injection
Maximum achieved sensory level
Time Frame: Up to 30 minutes after local anesthetic injection
Up to 30 minutes after local anesthetic injection
Time to achieve the maximum sensory level
Time Frame: Up to 30 minutes after local anesthetic injection
Up to 30 minutes after local anesthetic injection
Onset of motor blockade
Time Frame: Up to 30 minutes after local anesthetic injection
Up to 30 minutes after local anesthetic injection
Time to complete motor block
Time Frame: Up to 30 minutes after local anesthetic injection
Up to 30 minutes after local anesthetic injection
Duration of sensory block
Time Frame: Assessed every 20 minutes after achieving highest dermatome level of sensory analgesia
Time to two segmental dermatomes regression
Assessed every 20 minutes after achieving highest dermatome level of sensory analgesia
Duration of motor block
Time Frame: Assessed every 20 minutes after achieving Bromage 3 motor block
Time interval from achievement of Bromage 1 to regression of motor blockade to Bromage 1
Assessed every 20 minutes after achieving Bromage 3 motor block
Duration of analgesia
Time Frame: Time for requirement for rescue analgesia or VAS pain score >3 as postoperatively
Time from onset of sensory block to first complain of pain postoperatively as the epidural catheter will be removed after the surgery finished
Time for requirement for rescue analgesia or VAS pain score >3 as postoperatively
Number of epidural top-ups
Time Frame: Number of extra doses of local anesthetic given after injection of local anesthetic loading dose till end of the surgery
Number of extra doses of local anesthetic given after injection of local anesthetic loading dose till end of the surgery
Sedation score
Time Frame: Assessed every 20 minutes during the surgical procedure and postoperatively
Assessed every 20 minutes during the surgical procedure and postoperatively
Hemodynamic parameters
Time Frame: Assessed every 5 minutes from the start of anesthetic procedures till transfer the patients to the rooms
Assessed every 5 minutes from the start of anesthetic procedures till transfer the patients to the rooms
Perioperative side effects
Time Frame: During surgical period up to 7 days post-operatively
During surgical period up to 7 days post-operatively

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.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Reham Ali Abdelrahman, M.D., Cairo 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 1, 2019

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.
June 28, 2021

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.
July 31, 2021

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).
December 23, 2018

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.
December 31, 2018

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 2, 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.
September 1, 2021

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.
August 27, 2021

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.
August 1, 2021

More Information

Terms related to this study

Keywords

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.
  • IUD2900

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.

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