Postoperative PainNCT05286125
Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block
A study testing erector spinae plane (ESP) block and oblique subcostal transverse abdominis plane (TAP) block in people with Postoperative Pain, run by Zagazig University at 1 site in Egypt.
Trial summary
Comparing the impact of bilateral erector spinae plane block and transverse abdominis plane block on improving quality of pain management after umbilical hernia repair. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- erector spinae plane (ESP) block and oblique subcostal transverse abdominis plane (TAP) block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2021to 15 Dec 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients scheduled for elective umbilical hernia repair.
- Patient acceptance.
- Both sex
- Patient's age 21 - 60 years.
- Patients with American Society of Anesthesiologists (ASA) physical status I, II.
- BMI 25 - 30 kg m-2.
Who cannot join
- Uncooperative patients and patients with psychological problems.
- Patients with liver or renal impairment.
- Patients with contraindication to regional anesthesia.
- Patients with history of allergy to drug used in the study.
- Patients with chronic pain.
Trial locations and contacts
1 site in 1 country.
salwa s ElSherbeny, lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University hospital
Zagazig, Sharqia Province, 44511
Hala A ALsadek, professor, 01224897773 ext. 002
About this study
Official title: Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block for Controlling Postoperative Pain After Umbilical Hernia Repair
Comparing the impact of bilateral erector spinae plane block and transverse abdominis plane block on improving quality of pain management after umbilical hernia repair.
Read the detailed description
Postoperative pain is an important problem after umbilical hernia repair which has negative effects on patient's hemodynamics and cause delayed ambulation resulting in prolonged duration of hospital stay and poor patient satisfaction.
Multiple analgesic strategies have been proposed including Non steroidal anti-inflammatory drugs (NSAIDs), opioids, epidural analgesia. Each of them has its limitations.
Ultra¬sound guided regional anesthesia techniques for abdominal wall can be effective components of multimodal postoperative analgesia with limited side-effects Erector spinae plane (ESP) block is a promising para-spinal bock that can achieve both visceral and somatic abdominal analgesia if the injection was performed at a lower thoracic level. Transverse abdominis plane (TAP) block which is considered a peripheral nerve block that is aimed at anesthetizing nerves supplying the anterior abdominal wall.
We will compare between erector spinae plane block and transverse abdominis plane block for controlling postoperative pain after umbilical hernia repair.
Patients will be allocated randomly into two equal groups by a computer-generated randomization table Group (E) (n=26): Patients will receive erector spinae plane (ESP) block after completion of surgery.
Group (T) (n= 26): Patients will receive oblique subcostal transverse abdominis plane (TAP) block after completion of surgery
- Conditions
- Postoperative Pain
- Being tested
- erector spinae plane (ESP) block, oblique subcostal transverse abdominis plane (TAP) block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane (ESP) blockProcedure or surgery
Using the in plane technique, the needle will be advanced between the transverse process and erector spinae muscle. The correct location will be confirmed using 1ml of Local Anesthetic (LA) to view hydrodissection(12). 19ml of LA will be injected between the muscle and transverse process.
oblique subcostal transverse abdominis plane (TAP) blockProcedure or surgery
An echogenic needle will be inserted in-plane until the needle tip reaches the fascia between the rectus abdominis and the transverse abdominis muscles. Once the needle enters the TAP plane, a dynamic injection can be performed by advancing the needle under ultrasound guidance laterally in the pocket created by the initial injection of 5 - 10 mL of local anesthetic; as the needle is advanced, the remaining local anesthetic will be injected. This allows for a more lateral spread of the local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| erector spinae plane (ESP) block group ( (E) group) | Active comparator | Under aseptic conditions, a high frequency linear transducer will be placed on the spinous process at T8 level on the parasagittal plane and then slid 2.5-3 cm laterally to visualize the transverse process and erector spinae muscle. Receives: Procedure: erector spinae plane (ESP) block |
| oblique subcostal transverse abdominis plane (TAP) block ( (T) group) ) | Active comparator | Under aseptic conditions, the probe will be initially placed below the xyphoid process to view the linea alba, then directed obliquely down the costal margin while keeping the rectus abdominis muscle in view. The transverse abdominis muscle come into view below the rectus abdominis muscle. The probe will be advanced further until the semilunaris is viewed. Receives: Procedure: oblique subcostal transverse abdominis plane (TAP) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesic requirements
measuring the total doses of analgesic required to relieve the pain
Measured: 24 hours postoperative
Secondary outcomes (7)
Postoperative pain severity using Visual Analogue scale
assessing pain severity using Visual Analogue scale (VAS) (0-100mm)
Measured: 24 hours postoperative
Postoperative pain severity using Verbal Rating Scale
assessing pain severity using Verbal Rating Scale (mild, moderate and severe)
Measured: 24 hours postoperative
Postoperative pain severity using Numeric Rating Scale
assessing pain severity using Numeric Rating Scale (NRS) (0-10; 0, no pain; 10, worst pain)
Measured: 24 hours postoperative
Postoperative heart rate changes
monitoring postoperative changes in the heart rate (HR) measured by beat per minute (BPM) and comparing it with the preoperative measures
Measured: 24 hours postoperative
Postoperative blood pressure changes
monitoring postoperative changes in the blood pressure (BP) measured by mm Hg and comparing it with the preoperative measures.
Measured: 24 hours postoperative
Incidence of postoperative side effects
recording any postoperative complications as nausea and vomiting
Measured: 24 hours postoperative
Duration of postoperative hospital stay
measuring the delay in discharging the patients postoperative because of the pain
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 posted18 Mar 2022
- Study start15 Jan 2021
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
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 Zagazig 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michael Adel Shaker, Zagazig University
- Investigators
- Michael A shaker, lecturer, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286125
- Sponsor's protocol ID
- 8034-7-11-2021
- Status last verified
- Jul 2023
- First submitted
- 22 Dec 2021
- Last updated
- 12 Jul 2023
- 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 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block for Controlling Postoperative Pain After Umbilical Hernia Repair
- ClinicalTrials.gov ID
- NCT05286125
- Acronym / sponsor ID
- 8034-7-11-2021
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 18 Mar 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.
Comparing the impact of bilateral erector spinae plane block and transverse abdominis plane block on improving quality of pain management after umbilical hernia repair.
Detailed description
Postoperative pain is an important problem after umbilical hernia repair which has negative effects on patient's hemodynamics and cause delayed ambulation resulting in prolonged duration of hospital stay and poor patient satisfaction.
Multiple analgesic strategies have been proposed including Non steroidal anti-inflammatory drugs (NSAIDs), opioids, epidural analgesia. Each of them has its limitations.
Ultra¬sound guided regional anesthesia techniques for abdominal wall can be effective components of multimodal postoperative analgesia with limited side-effects Erector spinae plane (ESP) block is a promising para-spinal bock that can achieve both visceral and somatic abdominal analgesia if the injection was performed at a lower thoracic level. Transverse abdominis plane (TAP) block which is considered a peripheral nerve block that is aimed at anesthetizing nerves supplying the anterior abdominal wall.
We will compare between erector spinae plane block and transverse abdominis plane block for controlling postoperative pain after umbilical hernia repair.
Patients will be allocated randomly into two equal groups by a computer-generated randomization table Group (E) (n=26): Patients will receive erector spinae plane (ESP) block after completion of surgery.
Group (T) (n= 26): Patients will receive oblique subcostal transverse abdominis plane (TAP) block after completion of surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erector spinae plane (ESP) block group ( (E) group) | Active comparator | Procedure: erector spinae plane (ESP) blockUnder aseptic conditions, a high frequency linear transducer will be placed on the spinous process at T8 level on the parasagittal plane and then slid 2.5-3 cm laterally to visualize the transverse process and erector spinae muscle. |
| oblique subcostal transverse abdominis plane (TAP) block ( (T) group) ) | Active comparator | Procedure: oblique subcostal transverse abdominis plane (TAP) blockUnder aseptic conditions, the probe will be initially placed below the xyphoid process to view the linea alba, then directed obliquely down the costal margin while keeping the rectus abdominis muscle in view. The transverse abdominis muscle come into view below the rectus abdominis muscle. The probe will be advanced further until the semilunaris is viewed. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients scheduled for elective umbilical hernia repair.
- Patient acceptance.
- Both sex
- Patient's age 21 - 60 years.
- Patients with American Society of Anesthesiologists (ASA) physical status I, II.
Key exclusion criteria (5 listed)
- Uncooperative patients and patients with psychological problems.
- Patients with liver or renal impairment.
- Patients with contraindication to regional anesthesia.
- Patients with history of allergy to drug used in the study.
- Patients with chronic pain.
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 (ESP) blockUsing the in plane technique, the needle will be advanced between the transverse process and erector spinae muscle. The correct location will be confirmed using 1ml of Local Anesthetic (LA) to view hydrodissection(12). 19ml of LA will be injected between the muscle and transverse process. | Procedure or surgery | erector spinae plane (ESP) block group ( (E) group) |
| oblique subcostal transverse abdominis plane (TAP) blockAn echogenic needle will be inserted in-plane until the needle tip reaches the fascia between the rectus abdominis and the transverse abdominis muscles. Once the needle enters the TAP plane, a dynamic injection can be performed by advancing the needle under ultrasound guidance laterally in the pocket created by the initial injection of 5 - 10 mL of local anesthetic; as the needle is advanced, the remaining local anesthetic will be injected. This allows for a more lateral spread of the local anesthetic | Procedure or surgery | oblique subcostal transverse abdominis plane (TAP) block ( (T) group) ) |
Primary outcome
Postoperative analgesic requirements
Time frame: 24 hours postoperative
measuring the total doses of analgesic required to relieve the pain
7 secondary outcomes
Postoperative pain severity using Visual Analogue scale
Time frame: 24 hours postoperative
Postoperative pain severity using Verbal Rating Scale
Time frame: 24 hours postoperative
Postoperative pain severity using Numeric Rating Scale
Time frame: 24 hours postoperative
Postoperative heart rate changes
Time frame: 24 hours postoperative
Postoperative blood pressure changes
Time frame: 24 hours postoperative
Incidence of postoperative side effects
Time frame: 24 hours postoperative
Duration of postoperative hospital stay
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 12 Jul 2023.
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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.
salwa s ElSherbeny, lecturer contact
Michael A shaker, lecturer principal investigator
Zagazig 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 (ESP) block and oblique subcostal transverse abdominis plane (TAP) block in people with Postoperative Pain, run by Zagazig 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 6 inclusion and 5 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 12 Jul 2023. 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 michael A shaker, lecturer (01096457282 ext. 002, michaeladelshaker@gamil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesic requirements (time frame: 24 hours postoperative). 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 12 Jul 2023.