NCT07533760

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 10, 2026

Last Update Submit

April 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total Morphine Consumption

    The total amount of morphine (in milligrams) consumed by the patient via the Patient-Controlled Analgesia (PCA) device.

    First 24 hours postoperatively

Secondary Outcomes (2)

  • Numerical Rating Scale (NRS) Scores for Pain

    At postoperative 30 minutes, 2nd, 6th, 12th, and 24th hours

  • Number of Blocked Dermatomes

    20 minutes after the block procedure

Study Arms (2)

Group I

ACTIVE COMPARATOR

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

Group II

ACTIVE COMPARATOR

Patients in Group I 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

Interventions

The ESPB will be performed at the T8-T9 vertebral levels. The T7 vertebra, aligned with the inferior angles of the scapulae, will be identified, and the T8 vertebra will be located one level below via palpation. 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. After confirming the position between the erector spinae muscle and the transverse proces

Group IGroup II

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University Faculty of Medicine

Konya, 42040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 16, 2026

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations