BlockNCT06097286
A Comparative Study Between Ultrasound Guided External Oblique Intercostal Plane (EOIP) Block and Erector Spinae Plane (ESP) Block for Postoperative Analgesia in Upper Abdominal Surgeries
A study testing external oblique intercostal plane block and erector spinae plane block in people with Block, run by Ain Shams University.
Trial summary
Upper abdominal incisions, such as the oblique subcostal laparotomy, can cause severe pain and can lead to significant respiratory impairment. Erector spinae plane (ESP) block is the deposition of local anaesthetic (LA) in the interfascial plane at the paraspinal region. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Block
- What is being tested?
- external oblique intercostal plane block and erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Jun 2024
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with American Society of Anesthesiologists physical status (ASA) I and II.
- Both sex.
- 20 to 60 years old patients.
- upper abdominal surgeries.
Who cannot join
- Refusal of the patient to consent.
- Patients with ASA status III or IV
- Patients with bleeding disorders and coagulopathy (INR≥1.6 \& PTT≥50 sec).
- Infection at the injection site.
- Allergy to local anesthetics.
- Patients with ages less than 20 or more than 60
Show all 9Show fewer
- Patients with pre-existing myopathy or neuropathy.
- Patients with chronic pain syndromes.
- Patients with history of long acting opioids or steroids preoperatively.
About this study
Upper abdominal incisions, such as the oblique subcostal laparotomy, can cause severe pain and can lead to significant respiratory impairment.
Erector spinae plane (ESP) block is the deposition of local anaesthetic (LA) in the interfascial plane at the paraspinal region. It provides effective visceral and somatic analgesia.
Read more
External oblique intercostal plane (EOIP) block is a newly described block at which local anaesthetic (LA) is deposited in the interfascial plane deep to external oblique muscle at the sixth intercostal space. It provides blockade of the thoracoabdominal nerves at the level of T6 to T10.
In this study, the investigators compare between ultrasound (US) guided external oblique intercostal plane block and erector spinae plane block, in providing postoperative analgesia for upper abdominal surgeries
- Conditions
- Block
- Being tested
- external oblique intercostal plane block, erector spinae plane block
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external oblique intercostal plane blockProcedure or surgery
- EOIP Group (ŋ=25): Patients will receive ultrasound guided External oblique intercostal plane block with 20 ml of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a total volume of 20 ml.) at the end of procedure, unilaterally or bilaterally according to the surgery.
erector spinae plane blockProcedure or surgery
- ESP Group (ŋ=25): Patients will receive ultrasound guided Erector spinae plane block with 20 ml of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a total volume of 20 ml.) at the end of procedure, unilaterally or bilaterally according to the surgery.
| Study group | Role | What they receive |
|---|---|---|
| external oblique intercostal plane block | Active comparator | Not described Receives: Procedure: external oblique intercostal plane block |
| erector spinae plane block | Active comparator | Not described Receives: Procedure: erector spinae plane block |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of total 24 hour pethidine consumption (mg) .
to measure total 24 hour pethidine consumption postoperatively.
Measured: 24 hours postoperatively
Secondary outcomes (5)
visual analogue scale (VAS) at rest and movement.
recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours. The Visual Analogue Scale (VAS) measures pain intensity. The visual analogue scale (VAS) consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (pain as bad as it could possibly be).
Measured: 24 hours postoperatively
mean arterial blood pressure (MAP)
recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours
Measured: 24 hours postoperatively
heart rate (HR)
recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours
Measured: 24 hours postoperatively
incidence of postoperative complications (nausea and vomiting)
recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours
Measured: 24 hours postoperatively
time to start mobilization
recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlockStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097286
- Sponsor's protocol ID
- MD80/2023
- Status last verified
- Mar 2023
- First submitted
- 21 Sep 2023
- Last updated
- 24 Oct 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 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Ultrasound Guided External Oblique Intercostal Plane (EOIP) Block and Erector Spinae Plane (ESP) Block for Postoperative Analgesia in Upper Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT06097286
- Acronym / sponsor ID
- MD80/2023
- Conditions
- Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 24 Oct 2023 (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.
Upper abdominal incisions, such as the oblique subcostal laparotomy, can cause severe pain and can lead to significant respiratory impairment.
Erector spinae plane (ESP) block is the deposition of local anaesthetic (LA) in the interfascial plane at the paraspinal region. It provides effective visceral and somatic analgesia.
External oblique intercostal plane (EOIP) block is a newly described block at which local anaesthetic (LA) is deposited in the interfascial plane deep to external oblique muscle at the sixth intercostal space. It provides blockade of the thoracoabdominal nerves at the level of T6 to T10.
In this study, the investigators compare between ultrasound (US) guided external oblique intercostal plane block and erector spinae plane block, in providing postoperative analgesia for upper abdominal surgeries
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| external oblique intercostal plane block | Active comparator | Procedure: external oblique intercostal plane block |
| erector spinae plane block | Active comparator | Procedure: erector spinae plane block |
| control group | No intervention | – |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with American Society of Anesthesiologists physical status (ASA) I and II.
- Both sex.
- 20 to 60 years old patients.
- upper abdominal surgeries.
Key exclusion criteria (9 listed)
- Refusal of the patient to consent.
- Patients with ASA status III or IV
- Patients with bleeding disorders and coagulopathy (INR≥1.6 \& PTT≥50 sec).
- 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 |
|---|---|---|
| external oblique intercostal plane blocko EOIP Group (ŋ=25): Patients will receive ultrasound guided External oblique intercostal plane block with 20 ml of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a total volume of 20 ml.) at the end of procedure, unilaterally or bilaterally according to the surgery. | Procedure or surgery | external oblique intercostal plane block |
| erector spinae plane blocko ESP Group (ŋ=25): Patients will receive ultrasound guided Erector spinae plane block with 20 ml of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a total volume of 20 ml.) at the end of procedure, unilaterally or bilaterally according to the surgery. | Procedure or surgery | erector spinae plane block |
Primary outcome
amount of total 24 hour pethidine consumption (mg) .
Time frame: 24 hours postoperatively
to measure total 24 hour pethidine consumption postoperatively.
5 secondary outcomes
visual analogue scale (VAS) at rest and movement.
Time frame: 24 hours postoperatively
mean arterial blood pressure (MAP)
Time frame: 24 hours postoperatively
heart rate (HR)
Time frame: 24 hours postoperatively
incidence of postoperative complications (nausea and vomiting)
Time frame: 24 hours postoperatively
time to start mobilization
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing external oblique intercostal plane block and erector spinae plane block in people with Block, run by Ain Shams University.
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 9 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 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
amount of total 24 hour pethidine consumption (mg) . (time frame: 24 hours postoperatively). 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 24 Oct 2023.