Postoperative PainNCT07533760
Effect of Different Volumes of Erector Spinae Plane Block on Postoperative Opioid Consumption After Total Abdominal Hysterectomy
A study testing Erector Spinae Plane Block in people with Postoperative Pain and Abdominal Hysterectomy, run by Şule Arıcan at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain, Abdominal Hysterectomy, Pain
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Faculty of Medicine
Konya, 42040
About this study
Official title: 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.
- Conditions
- Postoperative Pain, Abdominal Hysterectomy, Pain
- Being tested
- Erector Spinae Plane Block
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
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
Erector Spinae Plane BlockProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Erector Spinae Plane Block |
| 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. Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Morphine Consumption
The total amount of morphine (in milligrams) consumed by the patient via the Patient-Controlled Analgesia (PCA) device.
Measured: First 24 hours postoperatively
Secondary outcomes (2)
Numerical Rating Scale (NRS) Scores for Pain
Pain intensity measured at rest and during movement (dynamic) using a scale from 0 (no pain) to 10 (worst possible pain).
Measured: At postoperative 30 minutes, 2nd, 6th, 12th, and 24th hours
Number of Blocked Dermatomes
The number of dermatomes with loss of hot-cold sensation above and below the surgical incision.
Measured: 20 minutes after the block procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Şule Arıcan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Şule Arıcan, Konya Necmettin Erbakan Üniversitesi
- Investigators
- Şule Arıcan, Assoc. Prof., Principal investigator, Necmettin Erbakan University Faculty of Medicine, Department of Anesthesiology and ReanimationHasan Çekdemir, specialist, Principal investigator, Hadim State Hospital, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533760
- Sponsor's protocol ID
- 2021/629
- Other IDs
- E-66175679-514.05.01-609037
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07533760
- Acronym / sponsor ID
- 2021/629
- Conditions
- Postoperative Pain, Abdominal Hysterectomy, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Şule ArıcanUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: Erector Spinae Plane BlockPatients 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. |
| Group II | Active comparator | Procedure: Erector Spinae Plane BlockPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockThe 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 or surgery | Group I |
| Erector Spinae Plane BlockThe 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 | Procedure or surgery | Group II |
Primary outcome
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.
2 secondary outcomes
Numerical Rating Scale (NRS) Scores for Pain
Time frame: At postoperative 30 minutes, 2nd, 6th, 12th, and 24th hours
Number of Blocked Dermatomes
Time frame: 20 minutes after the block procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şule Arıcan, Assoc. Prof. principal investigator
Necmettin Erbakan University Faculty of Medicine, Department of Anesthesiology and Reanimation
Hasan Çekdemir, specialist principal investigator
Hadim State Hospital, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block in people with Postoperative Pain and Abdominal Hysterectomy, run by Şule Arıcan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Morphine Consumption (time frame: First 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.