Bariatric Surgery CandidateNCT05592522
Efficacy of External Oblique Intercostal Block in Laparoscopic Bariatric Surgery
A study testing External oblique intercostal block, Oblique subcostal TAP block and Posterior Rectus sheath block in people with Bariatric Surgery Candidate and Pain, Postoperative, run by Al Mashfa Medical Center at 1 site in Saudi Arabia.
Trial summary
Laparoscopic bariatric procedures nowadays are employed under ERAS protocol as an ambulatory surgery. Pain after laparoscopic procedures arises significantly from port site incisions in the anterior abdominal wall, and shoulder pain (referred from visceral pain). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate, Pain, Postoperative, Narcotic Use
- What is being tested?
- External oblique intercostal block, Oblique subcostal TAP block and Posterior Rectus sheath block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 26 Oct 2022to 20 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age of 18 and 65;
- American Society of Anesthesia (ASA) class II or III
- elective laparoscopic bariatric procedure through trocars positioned at or above the um-bilicus (T10 dermatome).
Who cannot join
- preoperative chronic use or contraindication to opioid or NSAID
- allergy to bupivacaine
- local skin infection at the injection site of EOI or OSTAP blocks
- liver or renal insufficiency
- psychiatric, or neurological disease
- prior open abdominal surgery above T10 dermatome
- patients converted to open surgery; and patients expected to be subjected to more tissue trauma.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Al Mashfa medical center
Khobar, Eastern Provence, 34225/7564
About this study
Official title: Is External Oblique Intercostal Block Under Enhanced Recovery After Bariatric Surgery (ERABS) Superior to Oblique Subcostal Transversus Abdominus Block? A Randomized Control Trial
Laparoscopic bariatric procedures nowadays are employed under ERAS protocol as an ambulatory surgery. Pain after laparoscopic procedures arises significantly from port site incisions in the anterior abdominal wall, and shoulder pain (referred from visceral pain). Narcotic medications are utilized to manage postoperative pain, but its disadvantages include, increased post-operative nausea and vomiting (PONV), ileus, sedation and delayed hospital discharge.
Oblique subcostal transversus abdominis plane block (OSTAP) had been studied before and found to be effective in reducing post-operative morphine usage and produce good analgesia for about 24hours postoperatively.
Read more
The ultrasound-guided external oblique intercostal (EOI) block is a new technique which proved to produce unilateral analgesia at thoracic dermatomes supplying the anterior and lateral aspects of the upper abdomen.
The aim of this study was to test the hypothesis that US-guided EOI blocks can produce more reduction in opioid usage during the first 24 h after of laparoscopic bariatric surgeries when compared to oblique subcostal TAP (OSTAP) block.
- Being tested
- External oblique intercostal block, Oblique subcostal TAP block, Posterior Rectus sheath block
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External oblique intercostal blockOther
Also called EOI
EOI block:Under guidance of the linear high frequency transducer, sagittal plane between anterior axillary line and midclavicular line at the level of the 6th rib, In-plane approach between external oblique and intercostal muscles Hydrodissection with 30 ml of 0.25% bupivacaine hydrochloride .
Oblique subcostal TAP blockOther
Also called OSTAP
OSTAP block: The needle was inserted in plane through the rectus adjacent to costal margin Once the tip of the needle was visualized in between the rectus muscle and transversus abdominus muscle and negative pressure aspiration was demonstrated, 30 ml bupivacaine 0.25% was deposited within the plane and hydrodissection was noted.
Posterior Rectus sheath blockOther
Also called PRSB
Posterior rectus sheath block: Under linear ultrasound probe, the needle was advanced gradually through the rectus muscle posteriorly toward its medial edge, approaching the rectus sheath. After negative aspiration,12.5 mL bupivacaine 0.25% was injected until the rectus muscle was separated from the posterior rectus sheath by hydrodissection.
| Study group | Role | What they receive |
|---|---|---|
| EOI group | Experimental | Ultrasound-guided bilateral external oblique intercostal (EOI) using 30 ml of 0.25% bupivacaine hydrochloride and oblique subcostal transverse abdominis plane (OSTAP) block using Placebo (NSS 0.9%) 30 ml combined with bilateral posterior rectus sheath block with 15 ml bupivacaine 0.25%. Receives: Other: External oblique intercostal block; Other: Posterior Rectus sheath block |
| OSTAP group | Experimental | Ultrasound-guided bilateral oblique subcostal transverse abdominis plane (OSTAP) block using 30 ml of 0.25% bupivacaine hydrochloride and external oblique intercostal (EOI) using Placebo (NSS 0.9%) 30 ml combined with bilateral posterior rectus sheath block with 15 ml bupivacaine 0.25%. Receives: Other: Oblique subcostal TAP block; Other: Posterior Rectus sheath block |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h equivalent oral morphine consumption
Total pethidine consumption, calculated as an equivalent oral morphine dose, during the 24 hours,
Measured: 24 hour
Numerical rating scale (NRS)
Numerical rating scale (NRS) in the PACU, and on arrival to the ward at 0 hours then at 2, 4, 6, 12, and 24 hours postoperatively(NRS) with 0 = no pain, to 100mm = the worst imaginable pain at the specified time.
Measured: 24 hours
Secondary outcomes (3)
Quality of recovery 40 score(QoR-40)
Quality of recovery 40 score at 24 hours.Twelve questions measured the comfort state; 9 questions measured the emotional state; 7 questions measured the psychological state; 5 questions measured the physical independence and 7 questions measured the level of pain. Each question received a score of 1 to 5 with a worst possible score of 40 and a best possible score of 200
Measured: 24 hours
AMBULATION TIME
Time to first independent ambulation
Measured: 24 hours
Readiness for discharge
time to readiness for discharge were measured according to the modified postoperative discharge scoring system (PADSS). Patients were considered eligible for discharge if they achieved a total score ≥ 9 on the condition that the vital signs parameter score was not less than 2, and none of the other five parameters scored a zero
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 posted24 Oct 2022
- Study start26 Oct 2022
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al Mashfa Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mohamed Ibrahim Elsayed, Al Mashfa Medical Center
- Investigators
- Mohamed I ElSayed, Principal investigator, Al Mashfa Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592522
- Sponsor's protocol ID
- 1/10-2022
- Status last verified
- Feb 2023
- First submitted
- 19 Oct 2022
- Last updated
- 28 Feb 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 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is External Oblique Intercostal Block Under Enhanced Recovery After Bariatric Surgery (ERABS) Superior to Oblique Subcostal Transversus Abdominus Block? A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05592522
- Acronym / sponsor ID
- 1/10-2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Al Mashfa Medical CenterUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 24 Oct 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.
Laparoscopic bariatric procedures nowadays are employed under ERAS protocol as an ambulatory surgery. Pain after laparoscopic procedures arises significantly from port site incisions in the anterior abdominal wall, and shoulder pain (referred from visceral pain). Narcotic medications are utilized to manage postoperative pain, but its disadvantages include, increased post-operative nausea and vomiting (PONV), ileus, sedation and delayed hospital discharge.
Oblique subcostal transversus abdominis plane block (OSTAP) had been studied before and found to be effective in reducing post-operative morphine usage and produce good analgesia for about 24hours postoperatively.
The ultrasound-guided external oblique intercostal (EOI) block is a new technique which proved to produce unilateral analgesia at thoracic dermatomes supplying the anterior and lateral aspects of the upper abdomen.
The aim of this study was to test the hypothesis that US-guided EOI blocks can produce more reduction in opioid usage during the first 24 h after of laparoscopic bariatric surgeries when compared to oblique subcostal TAP (OSTAP) block.
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 |
|---|---|---|
| EOI group | Experimental | Other: External oblique intercostal block, Other: Posterior Rectus sheath blockUltrasound-guided bilateral external oblique intercostal (EOI) using 30 ml of 0.25% bupivacaine hydrochloride and oblique subcostal transverse abdominis plane (OSTAP) block using Placebo (NSS 0.9%) 30 ml combined with bilateral posterior rectus sheath block with 15 ml bupivacaine 0.25%. |
| OSTAP group | Experimental | Other: Oblique subcostal TAP block, Other: Posterior Rectus sheath blockUltrasound-guided bilateral oblique subcostal transverse abdominis plane (OSTAP) block using 30 ml of 0.25% bupivacaine hydrochloride and external oblique intercostal (EOI) using Placebo (NSS 0.9%) 30 ml combined with bilateral posterior rectus sheath block with 15 ml bupivacaine 0.25%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age of 18 and 65;
- American Society of Anesthesia (ASA) class II or III
- elective laparoscopic bariatric procedure through trocars positioned at or above the um-bilicus (T10 dermatome).
Key exclusion criteria (7 listed)
- preoperative chronic use or contraindication to opioid or NSAID
- allergy to bupivacaine
- local skin infection at the injection site of EOI or OSTAP blocks
- liver or renal insufficiency
- psychiatric, or neurological disease
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 blockAlso: EOIEOI block:Under guidance of the linear high frequency transducer, sagittal plane between anterior axillary line and midclavicular line at the level of the 6th rib, In-plane approach between external oblique and intercostal muscles Hydrodissection with 30 ml of 0.25% bupivacaine hydrochloride . | Other | EOI group |
| Oblique subcostal TAP blockAlso: OSTAPOSTAP block: The needle was inserted in plane through the rectus adjacent to costal margin Once the tip of the needle was visualized in between the rectus muscle and transversus abdominus muscle and negative pressure aspiration was demonstrated, 30 ml bupivacaine 0.25% was deposited within the plane and hydrodissection was noted. | Other | OSTAP group |
| Posterior Rectus sheath blockAlso: PRSBPosterior rectus sheath block: Under linear ultrasound probe, the needle was advanced gradually through the rectus muscle posteriorly toward its medial edge, approaching the rectus sheath. After negative aspiration,12.5 mL bupivacaine 0.25% was injected until the rectus muscle was separated from the posterior rectus sheath by hydrodissection. | Other | EOI group, OSTAP group |
Primary outcome
24h equivalent oral morphine consumption
Time frame: 24 hour
Total pethidine consumption, calculated as an equivalent oral morphine dose, during the 24 hours,
Numerical rating scale (NRS)
Time frame: 24 hours
Numerical rating scale (NRS) in the PACU, and on arrival to the ward at 0 hours then at 2, 4, 6, 12, and 24 hours postoperatively(NRS) with 0 = no pain, to 100mm = the worst imaginable pain at the specified time.
3 secondary outcomes
Quality of recovery 40 score(QoR-40)
Time frame: 24 hours
AMBULATION TIME
Time frame: 24 hours
Readiness for discharge
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 28 Feb 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.
Mohamed I ElSayed principal investigator
Al Mashfa Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External oblique intercostal block, Oblique subcostal TAP block and Posterior Rectus sheath block in people with Bariatric Surgery Candidate and Pain, Postoperative, run by Al Mashfa Medical Center at 1 site in Saudi Arabia.
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 3 inclusion and 7 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 28 Feb 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 Saudi Arabia. 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?
24h equivalent oral morphine consumption (time frame: 24 hour). The study lists 2 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 28 Feb 2023; AzTrials last refreshed its copy on 26 Oct 2026.