Postoperative PainNCT07830706
Effect of Erector Spinae Plane Block on Neuropathic Pain After Abdominal Hysterectomy
A study testing Bupivacaine and Standard Perioperative Analgesia in people with Postoperative Pain and Chronic Postsurgical Pain, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated whether bilateral erector spinae plane block (ESPB) performed before abdominal hysterectomy could reduce postoperative pain and the development of chronic and neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain, Chronic Postsurgical Pain
- What is being tested?
- Bupivacaine and Standard Perioperative Analgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 31 Dec 2025
- 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
- Adults aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Body mass index (BMI) <35 kg/m²
- Scheduled for elective total abdominal hysterectomy under general anesthesia
- Provided informed consent to participate in the study
Who cannot join
- Decompensated heart failure
- Severe respiratory distress
- Renal failure
- Hepatic failure
- History of opioid addiction
- Current anticoagulant use or bleeding diathesis
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Medical Faculty Hospital Konya, Türkiye
Konya
About this study
Official title: The Effect Of Erector Spinae Plane Block Performed In Abdominal Hysterectomy On Acute, Chronıc Postoperative and Neuropathic Pain: A Randomized Controlled Prospective Study
This study evaluated whether bilateral erector spinae plane block (ESPB) performed before abdominal hysterectomy could reduce postoperative pain and the development of chronic and neuropathic pain. Adult patients undergoing abdominal hysterectomy under general anesthesia were assigned to receive either bilateral ESPB with bupivacaine or standard perioperative analgesic management without ESPB. Postoperative pain was assessed during the early postoperative period and at 1 and 6 months after surgery. Chronic and neuropathic pain were evaluated at 1 and 6 months using validated pain assessment tools.
- Conditions
- Postoperative Pain, Chronic Postsurgical Pain
- Being tested
- Bupivacaine, Standard Perioperative Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
0.25% bupivacaine, 20 mL administered bilaterally as part of ultrasound-guided erector spinae plane block at T8-T9.
Standard Perioperative AnalgesiaOther
Participants received standard perioperative analgesic management according to the routine institutional protocol, without erector spinae plane block.
| Study group | Role | What they receive |
|---|---|---|
| ESPB Group | Experimental | Participants assigned to the ESPB group received bilateral ultrasound-guided erector spinae plane block at the T8-T9 level before surgery, with 20 mL of 0.25% bupivacaine administered on each side, in addition to standard perioperative analgesic management. Receives: Drug: Bupivacaine |
| Control Group | Active comparator | Participants assigned to the control group received standard perioperative analgesic management without erector spinae plane block. Receives: Other: Standard Perioperative Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic postoperative pain severity at 6 months
Chronic postoperative pain severity was assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
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.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Model description
- Model Description
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Yusifov, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830706
- Sponsor's protocol ID
- 2021/2976
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Erector Spinae Plane Block Performed In Abdominal Hysterectomy On Acute, Chronıc Postoperative and Neuropathic Pain: A Randomized Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT07830706
- Acronym / sponsor ID
- 2021/2976
- Conditions
- Postoperative Pain, Chronic Postsurgical Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 21 Sep 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.
This study evaluated whether bilateral erector spinae plane block (ESPB) performed before abdominal hysterectomy could reduce postoperative pain and the development of chronic and neuropathic pain. Adult patients undergoing abdominal hysterectomy under general anesthesia were assigned to receive either bilateral ESPB with bupivacaine or standard perioperative analgesic management without ESPB. Postoperative pain was assessed during the early postoperative period and at 1 and 6 months after surgery. Chronic and neuropathic pain were evaluated at 1 and 6 months using validated pain assessment tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| ESPB Group | Experimental | Drug: BupivacaineParticipants assigned to the ESPB group received bilateral ultrasound-guided erector spinae plane block at the T8-T9 level before surgery, with 20 mL of 0.25% bupivacaine administered on each side, in addition to standard perioperative analgesic management. |
| Control Group | Active comparator | Other: Standard Perioperative AnalgesiaParticipants assigned to the control group received standard perioperative analgesic management without erector spinae plane block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Body mass index (BMI) <35 kg/m²
- Scheduled for elective total abdominal hysterectomy under general anesthesia
- Provided informed consent to participate in the study
Key exclusion criteria (7 listed)
- Decompensated heart failure
- Severe respiratory distress
- Renal failure
- Hepatic failure
- History of opioid addiction
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 |
|---|---|---|
| Bupivacaine0.25% bupivacaine, 20 mL administered bilaterally as part of ultrasound-guided erector spinae plane block at T8-T9. | Drug | ESPB Group |
| Standard Perioperative AnalgesiaParticipants received standard perioperative analgesic management according to the routine institutional protocol, without erector spinae plane block. | Other | Control Group |
Primary outcome
Chronic postoperative pain severity at 6 months
Time frame: 6 months after surgery
Chronic postoperative pain severity was assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain imaginable).
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 23 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Standard Perioperative Analgesia in people with Postoperative Pain and Chronic Postsurgical Pain, run by Necmettin Erbakan University 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 5 inclusion and 7 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 23 Sep 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?
Chronic postoperative pain severity at 6 months (time frame: 6 months after surgery). 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 23 Sep 2026.