AzTrials
AzTrials

AnesthesiaNCT06168903

EOI Block Versus ESP Block in Laparoscopic Bariatric Surgery

A study testing Ultrasound guided EOI block in people with Anesthesia and Bariatric Surgery Candidate, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study aims to compare a single shot of bilateral ultrasound-guided EOI block and ESPB in terms of intraoperative opioid consumption, postoperative pain control in the first 24 hours, and the need for rescue analgesics. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Ultrasound guided EOI block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
5 Dec 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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Obese patients of any gender with a body mass index (BMI) of ≥ 35 kg/m2 with comorbidities or > 40 kg/m2 and American Society of Anesthesiologists (ASA) physical status I-III and aged between 18 and 70 years scheduled for laparoscopic bariatric surgery, that is, sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgery.

Who cannot join

  • Coagulopathy, infection at the injection site, allergy to local anesthetics, severe hepatic or renal disease, severe cardiopulmonary disease (≥ ASA IV), diabetic or other neuropathies, patients receiving opioids for chronic analgesic therapy, and inability to comprehend visual analogue scale (VAS).

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Cairo university Hospitals. kasralainy

    Cairo, Governorate, 002

    Nagy malak, 01552480258, nagymalak12345@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: External Oblique Intercostal Block Versus Erector Spinae Plane Block in Laparoscopic Bariatric Surgery: A Randomized Controlled Trial

This study aims to compare a single shot of bilateral ultrasound-guided EOI block and ESPB in terms of intraoperative opioid consumption, postoperative pain control in the first 24 hours, and the need for rescue analgesics.

Read the detailed description

The study is randomized, controlled, double blinded trial and conducted in Cairo university hospital after approval of departmental and institutional research ethics committee. Written informed consent will be obtained from all participants. Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes.

On arrival of the patients to operating room, patients will be secured with 20 gauge intravenous cannula. Monitoring will include ECG, non-invasive arterial blood pressure (NIBP), and pulse oximetry (SpO2). Before receiving general anesthesia, patients will be randomly assigned into one of the two study groups; EOI block Group and ESPB Group.

Induction of general anesthesia will be induced with patients in ramped position and after adequate preoxygenation using 1 µg/kg fentanyl (based on lean body weight), 2 mg/kg propofol (based on total body weight), and 0.5 mg/kg atracurium (based on the ideal body weight), in addition to 8mg IV dexamethasone for prevention of postoperative nausea \& vomiting. Endotracheal intubation will be established. Anesthesia will be maintained by 1.2% MAC of isoflurane with oxygen (50%) in air and 0.1 mg/kg of atracurium will be administered every 20 minutes as maintenance anesthetic drugs. Volume-controlled ventilation will be maintained with a tidal volume of 6 mL/kg of ideal body weight and the respiratory rate will be adapted to maintain ET CO2 between 30 and 40 mmHg, and a 10 cmH2O positive end-expiratory pressure (PEEP) will be applied in all patients. Monitoring through ECG, NIBP, pulse oximetry and capnography (ETCO2) continued throughout the surgeries.

US (Siemens ACUSON X300 Ultrasound System) guided blocks will be administered immediately after the induction of anesthesia and prior to surgical incision by consultant anesthesiologists who had experience in regional anesthesia and were familiar with the EOI and ESPB blocks.

EOI block Group (n=25): this group will receive bilateral ultrasound-guided external oblique intercostal block.

The technique of ultrasound-guided EOI block will be performed with the patient in supine position. A linear ultrasound probe (4-12MHz) will be placed paramedian sagittal orientation between the midclavicular and anterior axillary lines at the level of sixth rib, visualizing the external oblique and intercostal muscles. Local anesthetics inject the under the external oblique muscle.

A 22-gauge needle will be advanced in-plane superomedial-to-inferolateral direction, into the fascial plane between the external oblique and intercostal muscles at the caudal end of the sixth rib and between the sixth and seventh ribs. The location of the needle tip will be confirmed by hydrodissection of inter-fascial planes by 3 ml of normal saline. After negative aspiration, a total of 20 mL bupivacaine 0.25% will be injected in the fascial plane incrementally, aspirating every 5 ml and the block will be repeated on the other side.

ESPB Group (n=25): this group will receive bilateral ultrasound-guided erector spinae plane block The technique of ultrasound-guided ESPB will be performed with the patient in lateral position. A curvilinear ultrasound probe (5-7 MHz) will be placed transversely to identify tip of T9 transverse process 2.5-3 cm from midline then it will be rotated longitudinally to get a parasagittal view visualizing the transverse process as a hyperechoic curvilinear structure with prominent finger-like acoustic shadowing beneath (the trident sign), with lamina (sawtooth pattern), spinous process, and costochondral junction medially and laterally. The erector spinae muscles are identified superficial to the tip of the T9 transverse process. A 22-gauge needle will be advanced in-plane craniocaudally into the fascial plane deep to erector spinae muscle. The location of the needle tip will be confirmed by hydrodissection of erector spinae muscle from tip of transverse process by 3 ml of normal saline. After negative aspiration, a total of 20 mL bupivacaine 0.25% will be injected under the fascial plane incrementally, aspirating every 5 ml and the block will be repeated on the other side.

To achieve double blinding, patients will receive the block with 40 mL bupivacaine (0.25%) by the anesthetist. Another doctor not involved in the block procedure will evaluate the patients intraoperative and postoperative.

Intraoperative inadequate analgesia, indicated by increase of HR or MAP more than 20% above preinduction baseline values, will be managed using incremental 50 microgram doses of fentanyl. Intraoperative fentanyl consumption will be calculated. All patients will receive 10 minutes before the end of surgery 1 mg granisetron or 4 mg ondansetron IV for antiemetic prophylaxis and ketorolac 30mg IV and paracetamol 1g for postoperative analgesia. At the end of surgery, muscle relaxant will be reversed using neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Awake extubation will be established after adequate reversal of neuromuscular block.

Patients will be transported to PACU and placed in the semi-sitting position, and oxygen will be given via a nonrebreathing facemask with a reservoir bag. Postoperative pain will be assessed using VAS (where 0 corresponds to no pain and 100 mm to the worst pain) at 2, 4, 6, 12, 18, and 24 hours postoperatively.

Postoperatively, all patients will receive 1 g paracetamol every 6 h, 30 mg ketorolac every 12 h.

IV morphine titration will be carried out at patient wake-up to achieve pain control (VAS ≤ 30mm) by an attending anesthesiologist blinded to group allocation. Patients with a VAS score of ≥ 40mm and patients who will request rescue analgesia will be treated with IV morphine in 2 mg increments every 5 minutes with no upper limit for the total administered dose and total morphine consumption will be recorded. If the patient appeared sedated (Ramsay sedation scale > 2), and/or severe morphine-related side effects are encountered including respiratory depression (Spo2 < 95% and/or respiratory rate < 12 breaths/min), allergic reaction, hypotension, or severe pruritus, morphine titration will be stopped and the patient will be excluded from the study.

Being tested
Ultrasound guided EOI block
Keywords
External oblique intercostal, Erector spinae Block, Bariatric, laparoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided EOI blockProcedure or surgery

    Also called Ultrasound-guided ESPB block

    Before receiving general anesthesia, patients will be randomly assigned to one of the two study groups: the EOI block group or the ESPB group.

    Using Ultrasound (Siemens ACUSON X300 Ultrasound System), guided blocks will be administered immediately after the induction of anesthesia and prior to surgical incision by consultant anesthesiologists who have experience in regional anesthesia and are familiar with the EOI and ESPB blocks

Study groups in NCT06168903
Study groupRoleWhat they receive
EOI block Group (n=25):bilateral US-guided external oblique intercostal block.ExperimentalPatient in a supine position. A linear ultrasound probe will be placed in paramedian sagittal orientation between the midclavicular and anterior axillary lines at the level of the sixth rib, visualizing the external oblique and intercostal muscles. Local anesthetics are injected under the external oblique muscle. A 22-gauge needle will be advanced in the superomedial-to-inferolateral direction into the fascial plane between the external oblique and intercostal muscles at the caudal end of the sixth rib and between the sixth and seventh ribs.The location of the needle tip will be confirmed by hydrodissection of inter-fascial planes with 3 ml of normal saline. After negative aspiration, a total of 20 mL of bupivacaine 0.25% will be injected in the fascial plane incrementally, aspirating every 5 ml, and the block will be repeated on the other side.
Receives: Procedure: Ultrasound guided EOI block
ESPB Group (n=25): bilateral US-guided erector spinae plane blockActive comparatorPatient in a lateral position. A curvilinear ultrasound probe (5-7 MHz) will be placed transversely to identify tip of T9 transverse process 2.5-3 cm from the midline, then it will be rotated longitudinally to get a parasagittal view, visualizing the transverse process as a hyperechoic curvilinear structure with prominent finger-like acoustic shadowing beneath , lamina , spinous process, and costochondral junction medially and laterally. The erector spinae muscles are identified superficially to the tip of the T9 transverse process.The location of the needle tip will be confirmed by hydrodissection of the erector spinae muscle from the tip of the transverse process. After negative aspiration, a total of 20 mL bupivacaine 0.25% will be injected under the fascial plane incrementally, aspirating every 5 ml and the block will be repeated on the other side
Receives: Procedure: Ultrasound guided EOI block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual analogue pain score

    VAS Score at rest (static) and on movement (dynamic) at 2, 4, 6, 12, 18, and 24 hours postoperatively

    Measured: 24 hours

Secondary outcomes (6)
  1. Time needed to perform the block

    Time needed to perform the block, starting from scanning to finishing on both sides.

    Measured: 30-60 Minutes

  2. Fentanyl consumption

    Intraoperative fentanyl consumption

    Measured: Up to 4 hours

  3. Total morphine requirements

    Total morphine requirements: 24 hours postoperatively.

    Measured: 24 hours

  4. First postoperative analgesic request

    Time for the first postoperative analgesic request

    Measured: 24 hours

  5. Postoperative nausea and vomiting

    Incidence of PONV

    Measured: 24 hours

  6. Complications related to the blocks

    Incidence of complications related to the blocks

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2023
  2. Study start5 Dec 2023
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Resources

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
Model description
Obese patients with a body mass index (BMI) of ≥ 35 kg/m2 with comorbidities or \> 40 kg/m2 and American Society of Anesthesiologists (ASA) physical status I-III and aged between 18 and 70 years scheduled for laparoscopic bariatric surgery
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06168903
Sponsor's protocol ID
N-402-2023
Status last verified
May 2024
First submitted
5 Dec 2023
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound guided EOI block in people with Anesthesia and Bariatric Surgery Candidate, run by Cairo 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 1 inclusion and 1 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 16 May 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nagy malak (01552480258, nagymalak12345@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analogue pain score (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 16 May 2024.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in