- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07533760
Effect of Different Volumes of Erector Spinae Plane Block on Postoperative Opioid Consumption After Total Abdominal Hysterectomy
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Konya, Turkey (Türkiye), 42040
- Necmettin Erbakan University Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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
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.
|
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
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
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
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
Sponsor
Investigators
- 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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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