AnesthesiaNCT05541588
Erector Spinae Plane Block Versus Quadratus Lumborum Block For Postoperative Analgesia After Abdominal Hysterectomy
A study testing peripheral nerve block in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the analgesic efficacy of erector spinae plane block and quadratus lumborum block after abdominal hysterectomy surgery and postoperative opioid consumption. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- peripheral nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jul 2022to 10 Feb 2023
- 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 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with American Society of Anesthesiologists (ASA) physical status 1-3.
- scheduled for abdominal hysterectomy surgery.
Who cannot join
- History of allergy to the medications used in the study.
- Contraindication to regional anesthesia as coagulopathy, local infection.
- Severe hepatic impairment (child C).
- Sever Renal dysfunction (creatinine clearance < 30).
- Psychiatric or mental disorder affecting patient ability to interpret VAS score.
- Body mass index (BMI) ≥ 40 or ≤ 18 kg/m2.
- ASA IV.
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block Versus Quadratus Lumborum Block For Postoperative Analgesia After Abdominal Hysterectomy; A Randomized Comparative Study
The aim of this study is to compare the analgesic efficacy of erector spinae plane block and quadratus lumborum block after abdominal hysterectomy surgery and postoperative opioid consumption.
- Conditions
- Anesthesia
- Being tested
- peripheral nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral nerve blockProcedure or surgery
ultrasound guided nerve block
| Study group | Role | What they receive |
|---|---|---|
| ESPB | Active comparator | Erector Spinae Plane Block group Receives: Procedure: peripheral nerve block |
| QLB | Active comparator | Quadratus Lumborum Block group Receives: Procedure: peripheral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Post-operative pain severity assessed by visual analog scale (VAS) (range from 0-10., 0 no pain, 10 worst pain ).
Measured: 24 hours
Secondary outcomes (2)
Cumulative post-operative opioid consumption
opioid consumption
Measured: 24 hours
The onset of 1st analgesic request
time needed for 1st request of rescue analgesia
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start7 Jul 2022
- Primary completion20 Jan 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdou, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541588
- Sponsor's protocol ID
- ASUKH1
- Status last verified
- Jul 2024
- First submitted
- 13 Sep 2022
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Quadratus Lumborum Block For Postoperative Analgesia After Abdominal Hysterectomy; A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT05541588
- Acronym / sponsor ID
- ASUKH1
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 15 Sep 2022 (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.
The aim of this study is to compare the analgesic efficacy of erector spinae plane block and quadratus lumborum block after abdominal hysterectomy surgery and postoperative opioid consumption.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB | Active comparator | Procedure: peripheral nerve blockErector Spinae Plane Block group |
| QLB | Active comparator | Procedure: peripheral nerve blockQuadratus Lumborum Block group |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with American Society of Anesthesiologists (ASA) physical status 1-3.
- scheduled for abdominal hysterectomy surgery.
Key exclusion criteria (8 listed)
- History of allergy to the medications used in the study.
- Contraindication to regional anesthesia as coagulopathy, local infection.
- Severe hepatic impairment (child C).
- Sever Renal dysfunction (creatinine clearance < 30).
- Psychiatric or mental disorder affecting patient ability to interpret VAS score.
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 |
|---|---|---|
| peripheral nerve blockultrasound guided nerve block | Procedure or surgery | ESPB, QLB |
Primary outcome
Post-operative pain
Time frame: 24 hours
Post-operative pain severity assessed by visual analog scale (VAS) (range from 0-10., 0 no pain, 10 worst pain ).
2 secondary outcomes
Cumulative post-operative opioid consumption
Time frame: 24 hours
The onset of 1st analgesic request
Time frame: 24 hours
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 29 Jul 2024.
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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 peripheral nerve block in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
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 2 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 29 Jul 2024. 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 Egypt. 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?
Post-operative pain (time frame: 24 hours). 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 29 Jul 2024.