Abdominal HysterectomyNCT06766994
The Effect of Two Different Analgesic Techniques on Postoperative Recovery Quality
A study testing intrathecal morphine and Erector Spinae Plane Block in people with Abdominal Hysterectomy, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Hysterectomy is one of the most frequently performed surgical procedures after Caesarean section in many countries of the world and involves the removal of the uterine corpus with or without the cervix (total hysterectomy) or without the cervix (subtotal or supracervical hysterectomy) to treat a range of gynecological… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Abdominal Hysterectomy
- What is being tested?
- intrathecal morphine and Erector Spinae Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 scheduled to undergo abdominal hysterectomy surgery under general anesthesia
- Ages between 18-65
- American Society of Anesthesiologists classification I-II
Who cannot join
- Patients with a BMI ≥ 35,
- Patients with allergies to the drugs to be used in the study,
- Patients with severe liver or kidney failure,
- Patients with a history of long-term use of nonsteroidal anti-inflammatory and opioid analgesics,
- Patients with a history of gastrointestinal bleeding, peptic ulcers or inflammatory bowel disease,
- Patients with a history of diabetes or other neuropathic diseases,
Show all 12Show fewer
- Patients who developed atrioventricular block and bradycardia before surgery,
- Patients with a history of serious underlying respiratory disease and psychiatric diseases,
- Patients with ASA stage 3 or higher,
- Patients who cannot use a patient-controlled analgesia (PCA) device,
- Patients who need to stop the drug used in the study during surgery for any reason,
- Patients who do not consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University
Erzurum, Yakutiye, 25050
Berivan Bozan, MD, +905076131276, bbozan_93@hotmail.com
About this study
Official title: The Effect of Two Different Analgesic Techniques on Postoperative Recovery Quality in Patients Undergoing Elective Abdominal Hysterectomy
Hysterectomy is one of the most frequently performed surgical procedures after Caesarean section in many countries of the world and involves the removal of the uterine corpus with or without the cervix (total hysterectomy) or without the cervix (subtotal or supracervical hysterectomy) to treat a range of gynecological problems. Hysterectomy is performed abdominally, vaginally with laparotomy, or using minimally invasive techniques (laparoscopy, robotic surgery). The abdominal route for hysterectomy is the preferred route in 60-80% of these surgeries.
Postoperative recovery is a complex condition affected by various factors such as patient characteristics, surgical procedure, and anesthesia. There are many tools available to measure recovery quality. In recent years, the concept of recovery quality perceived by the patient has attracted attention. The Quality of Recovery-40 questionnaire (QoR-40) is an assessment test used to assess recovery quality and health status in the early postoperative stages. QoR-40 consists of 40 questions that evaluate patients' pain, physical comfort, physical independence, psychological support, and emotional state. Quality of Recovery-15 (QoR-15) is a short postoperative recovery scale developed and validated by Stark et al. in 2013. It is an abbreviated version of the QoR-40 scale. It is easy to use because it is shorter and can be completed in a short time. As in QoR-40, it contains 15 questions that evaluate pain, physical comfort, physical independence, psychological support, and emotional state by the patient.
Facilitating the recovery process and optimizing postoperative pain management is an important part of perioperative care. Multimodal analgesia, which combines local anesthesia, peripheral and non-opioid analgesics to minimize systemic opioid requirements and opioid-related side effects, has become increasingly popular. Epidural analgesia, which provides both intraoperative and postoperative analgesia as a complement to general anesthesia for elective abdominal hysterectomy, is an approach applied to achieve balanced and multimodal analgesia. Thus, while the adverse effects of high doses, especially opioid analgesics, applied with a single method are reduced, more effective treatment can be provided for postoperative pain where drugs and other methods alone are insufficient to provide complete analgesia.
- Conditions
- Abdominal Hysterectomy
- Being tested
- intrathecal morphine, Erector Spinae Plane Block
- Keywords
- abdominal hysterectomy, intrathecal morphine, erector spinal plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrathecal morphineOther
Preoperatively, patients will be injected with 200 μg morphine intrathecally with a 27G pencil point spinal needle at the L4-L5 or L3-L4 intervertebral space in a sitting position.
Erector Spinae Plane BlockOther
Preoperatively, patients will be placed in the prone position before the operation and an ESPB block will be applied bilaterally at the T9 vertebra level with the help of USG. 0.25% bupivacaine 20 ml will be used bilaterally as the blocking fluid.
| Study group | Role | What they receive |
|---|---|---|
| Group Intrathecal morphine | Active comparator | Not described Receives: Other: intrathecal morphine |
| Group Erector Spinae Plane Block | Active comparator | Not described Receives: Other: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery 24 hours after surgery assessed using the QoR-15 questionnaire
The primary objective of this study was to evaluate the quality of recovery 24 hours after surgery using the QoR-15 questionnaire after preoperative erector spinae plane block and intrathecal morphine injection in patients undergoing elective abdominal hysterectomy.
Measured: postoperative 24 hours
Secondary outcomes (4)
Total amount of opioids consumed
The secondary objective was to measure the total amount of opioid consumed in the first 24 hours postoperatively.
Measured: postoperative 24 hours
pain scores with movement and at rest
Evaluation of pain scores during movement and rest within 24 hours postoperatively using the Visual Analog Scale
Measured: postoperative 24 hours
irst analgesic requirement
Time to first analgesic requirement in the postoperative period
Measured: postoperative 24 hours
Advers events
incidence of side effects (nausea, vomiting, pruritus, urinary retention) for 24 hours
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start25 May 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal HysterectomyStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berivan Bozan, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766994
- Sponsor's protocol ID
- B.30.2.YYU.0.01.00.00/105
- Status last verified
- May 2025
- First submitted
- 4 Jan 2025
- Last updated
- 30 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
PubMed 10740540Hein A, Rosblad P, Gillis-Haegerstrand C, Schedvins K, Jakobsson J, Dahlgren G. Low dose intrathecal morphine effects on post-hysterectomy pain: a randomized placebo-controlled study. Acta Anaesthesiol Scand. 2012 Jan;56(1):102-9. doi: 10.1111/j.1399-6576.2011.02574.x.
PubMed 22150410
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Analgesic Techniques on Postoperative Recovery Quality in Patients Undergoing Elective Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT06766994
- Acronym / sponsor ID
- B.30.2.YYU.0.01.00.00/105
- Conditions
- Abdominal Hysterectomy
- Keywords
- abdominal hysterectomy, intrathecal morphine, erector spinal plane block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 9 Jan 2025 (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.
Hysterectomy is one of the most frequently performed surgical procedures after Caesarean section in many countries of the world and involves the removal of the uterine corpus with or without the cervix (total hysterectomy) or without the cervix (subtotal or supracervical hysterectomy) to treat a range of gynecological problems. Hysterectomy is performed abdominally, vaginally with laparotomy, or using minimally invasive techniques (laparoscopy, robotic surgery). The abdominal route for hysterectomy is the preferred route in 60-80% of these surgeries.
Postoperative recovery is a complex condition affected by various factors such as patient characteristics, surgical procedure, and anesthesia. There are many tools available to measure recovery quality. In recent years, the concept of recovery quality perceived by the patient has attracted attention. The Quality of Recovery-40 questionnaire (QoR-40) is an assessment test used to assess recovery quality and health status in the early postoperative stages. QoR-40 consists of 40 questions that evaluate patients' pain, physical comfort, physical independence, psychological support, and emotional state. Quality of Recovery-15 (QoR-15) is a short postoperative recovery scale developed and validated by Stark et al. in 2013. It is an abbreviated version of the QoR-40 scale. It is easy to use because it is shorter and can be completed in a short time. As in QoR-40, it contains 15 questions that evaluate pain, physical comfort, physical independence, psychological support, and emotional state by the patient.
Facilitating the recovery process and optimizing postoperative pain management is an important part of perioperative care. Multimodal analgesia, which combines local anesthesia, peripheral and non-opioid analgesics to minimize systemic opioid requirements and opioid-related side effects, has become increasingly popular. Epidural analgesia, which provides both intraoperative and postoperative analgesia as a complement to general anesthesia for elective abdominal hysterectomy, is an approach applied to achieve balanced and multimodal analgesia. Thus, while the adverse effects of high doses, especially opioid analgesics, applied with a single method are reduced, more effective treatment can be provided for postoperative pain where drugs and other methods alone are insufficient to provide complete analgesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Intrathecal morphine | Active comparator | Other: intrathecal morphine |
| Group Erector Spinae Plane Block | Active comparator | Other: 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 (3 listed)
- Patients scheduled to undergo abdominal hysterectomy surgery under general anesthesia
- Ages between 18-65
- American Society of Anesthesiologists classification I-II
Key exclusion criteria (12 listed)
- Patients with a BMI ≥ 35,
- Patients with allergies to the drugs to be used in the study,
- Patients with severe liver or kidney failure,
- Patients with a history of long-term use of nonsteroidal anti-inflammatory and opioid analgesics,
- Patients with a history of gastrointestinal bleeding, peptic ulcers or inflammatory bowel disease,
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 |
|---|---|---|
| intrathecal morphinePreoperatively, patients will be injected with 200 μg morphine intrathecally with a 27G pencil point spinal needle at the L4-L5 or L3-L4 intervertebral space in a sitting position. | Other | Group Intrathecal morphine |
| Erector Spinae Plane BlockPreoperatively, patients will be placed in the prone position before the operation and an ESPB block will be applied bilaterally at the T9 vertebra level with the help of USG. 0.25% bupivacaine 20 ml will be used bilaterally as the blocking fluid. | Other | Group Erector Spinae Plane Block |
Primary outcome
Quality of recovery 24 hours after surgery assessed using the QoR-15 questionnaire
Time frame: postoperative 24 hours
The primary objective of this study was to evaluate the quality of recovery 24 hours after surgery using the QoR-15 questionnaire after preoperative erector spinae plane block and intrathecal morphine injection in patients undergoing elective abdominal hysterectomy.
4 secondary outcomes
Total amount of opioids consumed
Time frame: postoperative 24 hours
pain scores with movement and at rest
Time frame: postoperative 24 hours
irst analgesic requirement
Time frame: postoperative 24 hours
Advers events
Time frame: postoperative 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Results publication: PubMed 10740540Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
- Results publication: PubMed 22150410Hein A, Rosblad P, Gillis-Haegerstrand C, Schedvins K, Jakobsson J, Dahlgren G. Low dose intrathecal morphine effects on post-hysterectomy pain: a randomized placebo-controlled study. Acta Anaesthesiol Scand. 2012 Jan;56(1):102-9. doi: 10.1111/j.1399-6576.2011.02574.x.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrathecal morphine and Erector Spinae Plane Block in people with Abdominal Hysterectomy, run by Ataturk 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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 30 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berivan Bozan (+90 (507) 613 12 76, bbozan_93@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery 24 hours after surgery assessed using the QoR-15 questionnaire (time frame: postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06766994, which also lists 2 linked publications.
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 30 May 2025.