Uterine DiseasesNCT05533710
Comparison Between Erector Spinae Plane Block and Transversus Abdominis Plane Block on Postoperative Analgesia After Total Abdominal Hysterectomy
A study testing erector spinae plane block and transversus abdominis plane block in people with Uterine Diseases, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to compare the ultrasound-guided bilateral erector spinae block versus the ultrasound-guided bilateral transversus abdominis plane block on postoperative analgesia after total abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Uterine Diseases
- What is being tested?
- erector spinae plane block and transversus abdominis plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Aug 2021to Aug 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients American Society of Anesthesiologists physical status (ASA) I and II.
- Female sex.
- Age between 40 to 60 years old.
- Scheduled for elective total abdominal hysterectomy surgeries.
Who cannot join
- Patient's refusal.
- Patients who received long-acting opioids preoperatively.
- Patients with bleeding disorders and coagulopathy.
- Infection at the injection site.
- Allergy to local anesthetics.
- Patients with significant cognitive dysfunction.
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- Patients with diabetic neuropathy.
- Patients with uncontrolled hypertension or diabetes.
- Patients with advanced cardiac, respiratory, hepatic or renal disease.
- Patients with viral hepatitis or HIV.
- Surgeries which have been complicated or prolonged (more than 150 mins).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11591
israa ihab, MSc, 01005461696 ext. +2, israa_ihab@med.asu.edu.eg
About this study
Official title: Comparative Study Between Bilateral Ultrasound-Guided Erector Spinae Plane Block Versus Bilateral Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Analgesia After Total Abdominal Hysterectomy
This study aims to compare the ultrasound-guided bilateral erector spinae block versus the ultrasound-guided bilateral transversus abdominis plane block on postoperative analgesia after total abdominal hysterectomy.
- Conditions
- Uterine Diseases
- Being tested
- erector spinae plane block, transversus abdominis plane block
- Keywords
- ESPB, TAP
- Medical subject headings
- Uterine Diseases
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
Patients will receive ESB. In the lateral decubitus, after skin sterilization, ESP block will be performed at the level of T9
transversus abdominis plane blockProcedure or surgery
patients will receive TAP block in supine position after skin sterilization, TAP block will be performed between internal oblique and transversus abdominis muscles
| Study group | Role | What they receive |
|---|---|---|
| Group A : erector spinae block. | Experimental | patients will receive bilateral ultrasound guided erector spinae block. Receives: Procedure: erector spinae plane block |
| Group B : transversus abdominis plane block. | Experimental | patients will receive bilateral ultrasound guided transversus abdominis plane block. Receives: Procedure: transversus abdominis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Compare postoperative pain intensity using the total amount of morphine consumption in the first 24 hours after the operation, and the time for first call rescue analgesia
Measured: 24 hours postoperative
Visual Analog Scale Score
Compare postoperative pain intensity using VAS score in the first 24 hours after the operation.The VAS score is a 10-cm line labeled with "worst pain imaginable" on the right border, and "no pain" on the left border (ranging from 0 by indicating no pain to 10 indicating extreme pain).
Measured: 24 hours postoperative
The time for first call rescue analgesia
the time for first call rescue analgesia
Measured: 24 hours postoperative
Secondary outcomes (2)
Patient satisfaction
Measure patient satisfaction by asking the patient if he is satisfied or not "yes or no"
Measured: 24 hours postoperative
Recognize the adverse effects
Recognize the adverse effects
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start28 Aug 2021
- Primary completionJun 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Israa Ihab Abdel Aziz, Ain Shams University
- Investigators
- ossama mansour, professor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533710
- Sponsor's protocol ID
- ainshamsU FAMSU
- Status last verified
- Sep 2022
- First submitted
- 3 Sep 2022
- Last updated
- 9 Sep 2022
- 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 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Bilateral Ultrasound-Guided Erector Spinae Plane Block Versus Bilateral Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Analgesia After Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT05533710
- Acronym / sponsor ID
- ainshamsU FAMSU
- Conditions
- Uterine Diseases
- Keywords
- ESPB, TAP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 Aug 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 9 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.
This study aims to compare the ultrasound-guided bilateral erector spinae block versus the ultrasound-guided bilateral transversus abdominis plane block on postoperative analgesia after total abdominal hysterectomy.
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 A : erector spinae block. | Experimental | Procedure: erector spinae plane blockpatients will receive bilateral ultrasound guided erector spinae block. |
| Group B : transversus abdominis plane block. | Experimental | Procedure: transversus abdominis plane blockpatients will receive bilateral ultrasound guided transversus abdominis plane block. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients American Society of Anesthesiologists physical status (ASA) I and II.
- Female sex.
- Age between 40 to 60 years old.
- Scheduled for elective total abdominal hysterectomy surgeries.
Key exclusion criteria (11 listed)
- Patient's refusal.
- Patients who received long-acting opioids preoperatively.
- Patients with bleeding disorders and coagulopathy.
- Infection at the injection site.
- Allergy to local anesthetics.
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 blockPatients will receive ESB. In the lateral decubitus, after skin sterilization, ESP block will be performed at the level of T9 | Procedure or surgery | Group A : erector spinae block. |
| transversus abdominis plane blockpatients will receive TAP block in supine position after skin sterilization, TAP block will be performed between internal oblique and transversus abdominis muscles | Procedure or surgery | Group B : transversus abdominis plane block. |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperative
Compare postoperative pain intensity using the total amount of morphine consumption in the first 24 hours after the operation, and the time for first call rescue analgesia
Visual Analog Scale Score
Time frame: 24 hours postoperative
Compare postoperative pain intensity using VAS score in the first 24 hours after the operation.The VAS score is a 10-cm line labeled with "worst pain imaginable" on the right border, and "no pain" on the left border (ranging from 0 by indicating no pain to 10 indicating extreme pain).
The time for first call rescue analgesia
Time frame: 24 hours postoperative
the time for first call rescue analgesia
2 secondary outcomes
Patient satisfaction
Time frame: 24 hours postoperative
Recognize the adverse effects
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- 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.
ossama mansour, professor study chair
Ain Shams University
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 and transversus abdominis plane block in people with Uterine Diseases, 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 9 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact israa ihab, MSc (01005461696 ext. +2, israa_ihab@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 24 hours postoperative). The study lists 3 primary outcomes in all. 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 9 Sep 2022.