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Clinical Trials/NCT07533760
NCT07533760
Completed
Not Applicable

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

Şule Arıcan1 site in 1 country80 target enrollmentStarted: January 1, 2022Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Şule Arıcan
Enrollment
80
Locations
1
Primary Endpoint
Total Morphine Consumption

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: Erector Spinae Plane Block (Procedure)

Group II

Active Comparator

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.

Intervention: Erector Spinae Plane Block (Procedure)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor
Şule Arıcan
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Şule Arıcan

Associate Professor

Konya Necmettin Erbakan Üniversitesi

Study Sites (1)

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