Effect of Different Volumes of Erector Spinae Plane Block on Postoperative Opioid Consumption After Total Abdominal Hysterectomy

April 17, 2026 updated by: Şule Arıcan

Comparison of the Effectiveness of Erector Spinae Plane Block Administered at Different Volumes on Postoperative Opioid Consumption and Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized, Prospective, Double-Blind Study

his study aims to investigate the effects of different volumes of ultrasound-guided erector spinae plane block (ESPB) on postoperative pain and opioid consumption in patients undergoing total abdominal hysterectomy. The researchers aim to determine whether varying the volume of local anesthetic in the ESPB can reduce the amount of morphine required by patients and improve pain scores during the first 24 hours after surgery.

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.
80

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

  • Turkey (Türkiye)
      • Konya, Turkey (Türkiye), 42040
        • Necmettin Erbakan University Faculty of Medicine

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged between 18 and 65 years.
  • Patients with American Society of Anesthesiologists (ASA) physical status I-III.
  • Patients scheduled to undergo elective total abdominal hysterectomy surgery.

Exclusion Criteria:

  • Obese patients (Body Mass Index > 30 kg/m²).
  • Patients with local skin infection at the site of needle insertion.
  • Patients with a known allergy to any of the medications used in the study.
  • Patients with coagulopathy.
  • Patients with chronic opioid consumption.
  • Patients with an inability to use the Patient-Controlled Analgesia (PCA) device.
  • Patients with advanced hepatic or renal failure.
  • Patients who refuse to participate in the study.

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: Treatment
  • 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: Group I
Patients in Group I received a preoperative bilateral ultrasound-guided erector spinae plane block (ESPB) with 20 ml of 0.25% bupivacaine hydrochloride (prepared by combining 10 ml of 0.5% bupivacaine hydrochloride with 10 ml of saline) for each side.
Procedure: Erector Spinae Plane Block

The ESPB will be performed at the T8-T9 vertebral levels. Patients will be placed in the prone position, and skin preparation will be performed with 10% povidone-iodine. Local anesthesia of the skin and subcutaneous tissue will be provided with 3 ml of 2% lidocaine at the target injection site.

Under ultrasound guidance, a sterile-covered linear probe (8 MHz) will be used to visualize the T8 spinous process in the horizontal plane at the midline. The probe will then be rotated to the longitudinal plane, approximately 3 cm lateral to the midline, to visualize the transverse process and the overlying erector spinae muscle. A 22-gauge, 80-mm block needle will be advanced in-plane in a cranio-caudal direction until it contacts the transverse process. The needle was then withdrawn slightly, and its placement between the erector spinae muscle and the transverse process was confirmed through hydrodissection. The patients in Group I received 20 ml of 0.25% (2.5 mg/ml) bupivacaine hydrochloride

Procedure: Erector Spinae Plane Block
The ESPB will be performed at the T8-T9 vertebral levels. Patients will be placed in the prone position, and skin preparation will be performed with 10% povidone-iodine. Local anesthesia of the skin and subcutaneous tissue will be provided with 3 ml of 2% lidocaine at the target injection site.Under ultrasound guidance, a sterile-covered linear probe (8 MHz) will be used to visualize the T8 spinous process in the horizontal plane at the midline. The probe will then be rotated to the longitudinal plane, approximately 3 cm lateral to the midline, to visualize the transverse process and the overlying erector spinae muscle. A 22-gauge, 80-mm block needle will be advanced in-plane in a cranio-caudal direction until it contacts the transverse process. The needle was then withdrawn slightly, and its placement between the erector spinae muscle and the transverse process was confirmed through hydrodissection. The patients in Group II received 30 ml of 0.25% (2.5 mg/ml) bupivacaine hydrochloride
Active Comparator: Group II
Patients in Group II received a preoperative bilateral ultrasound-guided erector spinae plane block (ESPB) with 30 ml of 0.25% bupivacaine hydrochloride (prepared by combining 15 ml of 0.5% bupivacaine hydrochloride with 15 ml of saline) for each side.
Procedure: Erector Spinae Plane Block

The ESPB will be performed at the T8-T9 vertebral levels. Patients will be placed in the prone position, and skin preparation will be performed with 10% povidone-iodine. Local anesthesia of the skin and subcutaneous tissue will be provided with 3 ml of 2% lidocaine at the target injection site.

Under ultrasound guidance, a sterile-covered linear probe (8 MHz) will be used to visualize the T8 spinous process in the horizontal plane at the midline. The probe will then be rotated to the longitudinal plane, approximately 3 cm lateral to the midline, to visualize the transverse process and the overlying erector spinae muscle. A 22-gauge, 80-mm block needle will be advanced in-plane in a cranio-caudal direction until it contacts the transverse process. The needle was then withdrawn slightly, and its placement between the erector spinae muscle and the transverse process was confirmed through hydrodissection. The patients in Group I received 20 ml of 0.25% (2.5 mg/ml) bupivacaine hydrochloride

Procedure: Erector Spinae Plane Block
The ESPB will be performed at the T8-T9 vertebral levels. Patients will be placed in the prone position, and skin preparation will be performed with 10% povidone-iodine. Local anesthesia of the skin and subcutaneous tissue will be provided with 3 ml of 2% lidocaine at the target injection site.Under ultrasound guidance, a sterile-covered linear probe (8 MHz) will be used to visualize the T8 spinous process in the horizontal plane at the midline. The probe will then be rotated to the longitudinal plane, approximately 3 cm lateral to the midline, to visualize the transverse process and the overlying erector spinae muscle. A 22-gauge, 80-mm block needle will be advanced in-plane in a cranio-caudal direction until it contacts the transverse process. The needle was then withdrawn slightly, and its placement between the erector spinae muscle and the transverse process was confirmed through hydrodissection. The patients in Group II received 30 ml of 0.25% (2.5 mg/ml) bupivacaine hydrochloride

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
Total Morphine Consumption
Time Frame: First 24 hours postoperatively
The total amount of morphine (in milligrams) consumed by the patient via the Patient-Controlled Analgesia (PCA) device.
First 24 hours postoperatively

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
Numerical Rating Scale (NRS) Scores for Pain
Time Frame: At postoperative 30 minutes, 2nd, 6th, 12th, and 24th hours
Pain intensity measured at rest and during movement (dynamic) using a scale from 0 (no pain) to 10 (worst possible pain).
At postoperative 30 minutes, 2nd, 6th, 12th, and 24th hours
Number of Blocked Dermatomes
Time Frame: 20 minutes after the block procedure
The number of dermatomes with loss of hot-cold sensation above and below the surgical incision.
20 minutes after the block procedure

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.
Şule Arıcan

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: Şule Arıcan, Assoc. Prof., Necmettin Erbakan University Faculty of Medicine, Department of Anesthesiology and Reanimation
  • Principal Investigator: Hasan Çekdemir, specialist, Hadim State Hospital, Department of Anesthesiology and Reanimation

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.
January 1, 2022

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 1, 2022

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.
June 1, 2022

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).
April 10, 2026

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.
April 10, 2026

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.
April 16, 2026

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.
April 22, 2026

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.
April 17, 2026

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.
April 1, 2026

More Information

Terms related to this study

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.
  • 2021/629
  • E-66175679-514.05.01-609037 (Other Identifier: Turkish Medicines and Medical Devices Agency (TITCK))

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.

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