Bariatric Surgery CandidateNCT03747406
Erector Spinae Block and Transverse Abdominis Plane Block for Sleeve Gasterectomy
A study testing Erector spinae plane block and TAP block in people with Bariatric Surgery Candidate, run by Dalia Ismail at 1 site in Egypt.
Trial summary
assess the efficacy of ultrasound guided erector spinae block to decrease the requirement for analgesics after laparoscopic sleeve gastrectomy and to decrease postoperative pain scores and opioid consumption compared to subcostal transverses abdominis block. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Erector spinae plane block and 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
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 10 Jul 2019
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patients from 18 to 59 years.
- BMI > 40 kg/m2
- Genders eligible for study: both.
- ASA I-III.
- No contraindications for application of regional anesthesia as Patient refusal, local anesthetic allergy, local sepsis or infection at puncture site, INR > 1.5 or < 12 hours post LMWH.
Who cannot join
- • Patient refusal.
- Extremes of age.
- ASA IV.
- Increased intracranial pressure.
- Coagulopathy or thrombocytopenia less than 100000/ml.
- Sepsis (increased risk of meningitis).
Show all 9Show fewer
- Infection at the puncture site.
- Pre-existing neurologic disease.
- History of allergy to local anesthetic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Ultrasound-guided Erector Spinae Block and Transverse Abdominis Plane Block in Obese Patients Undergoing Sleeve Gasterectomy.
assess the efficacy of ultrasound guided erector spinae block to decrease the requirement for analgesics after laparoscopic sleeve gastrectomy and to decrease postoperative pain scores and opioid consumption compared to subcostal transverses abdominis block.
Read the detailed description
Primary outcomes
- Cumulative opioid consumption during the first 24 h postoperatively. For the purpose of comparison, all opioids administered postoperatively will be converted to IV morphine equivalent doses using standard opioid dosage conversion tables.
Secondary outcome parameters
- Pain assessment by the aid of Visual analogue scale (VAS), which is consisted of a "10 cm" line with one end labeled no pain and other end labeled worst intolerable pain. The patients marked the line at the point that best describing the pain intensity. The preoperative assessment included training of the patients about (VAS) for postoperative pain. The length of the line to the patient's mark will be measured and recorded postoperative after 30 min., 4, 6, 8, and 24 hours.
- Failure rate of the block will be calculated, where the block will be considered a failed block if the patient requires more than two doses of rescue analgesia in the first hour postoperatively.
- Duration of surgery (from skin incision till skin closure) and general anesthesia (from induction of GA till extubation).
- Incidence of complications, such as: Nerve injury, Hematoma formation, LA toxicity, and intravascular injection.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Erector spinae plane block, TAP block
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
the level between T9 and T10 will be identified using ultrasound as well as transverse processes depth. An array probe will be applied longitudinal orientation 3 cm lateral midline. The erector spinae and the psoas muscle will be identified. A skin wheal will be made using lidocaine 1% at each level and then a 22-gauge Tuohy needle will be advanced inplane until it made contact with the transverse process. The needle will be withdrawn slightly and 30cc of bupivacaine 0.25 % (15ml for each side) will be injected slowly after negative aspiration was confirmed. The same procedure will be repeated in the contralateral side.
TAP blockProcedure or surgery
a linear array transducer 5-12 MHz will be positioned inferior and parallel to the costal margin in a medio-lateral orientation. The external oblique, internal oblique and transverse abdominis muscles will be identified immediately lateral to the linea semilunaris. A a 22-gauge needle will be advanced medially and in-plane to the US beam until the tip lies between the fascia of the internal oblique muscle and the transverse abdominis muscle layers. 30 ml of 0.25 % bupivacaine will be injected in each side and the spread will be observed between the two muscles layers.
| Study group | Role | What they receive |
|---|---|---|
| ESP group | Experimental | The patient rolled to his side, the level between T9 and T10 identified using ultrasound. An 8-14 MHz curved array probe (Siemens ACUSON X300 Ultrasound System) will be applied longitudinal orientation 3 cm lateral midline. The erector spinae and the psoas muscle will be identified. A skin wheal will be made using lidocaine 1% at each level and then a 22-gauge, 8 cm Tuohy needle (Perifix Epidural Needle) will be advanced inplane until contact with the transverse process. The needle will be withdrawn slightly and 30cc of bupivacaine 0.25 % (15ml for each side) will be injected slowly after negative aspiration confirmed. The same procedure will be repeated in the contralateral side. Receives: Procedure: Erector spinae plane block |
| TAP group | Experimental | The patient in supine position. Under complete aseptic conditions, a linear array transducer 5-12 MHz (Siemens ACUSON X300 Ultrasound System) will be positioned inferior and parallel to the costal margin in a medio-lateral orientation. The external oblique, internal oblique and transverse abdominis muscles will be identified immediately lateral to the linea semilunaris. A a 22-gauge, 8 cm Tuohy needle (Perifix Epidural Needle) will be advanced medially and in-plane to the US beam until the tip lies between the fascia of the internal oblique muscle and the transverse abdominis muscle layers. 30 ml of 0.25 % bupivacaine will be injected in each side and the spread will be observed between the two muscles layers. Receives: Procedure: TAP block |
| opioid group | No intervention | will receive intravenous morphine with general anesthesia and total opioid consumption will be calculated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption during the first 24 h postoperatively
measure total opioid dose in 24 hours after surgery
Measured: 24 hours after surgery
Secondary outcomes (1)
pain assessment by Visual Analog Scale
it is a "10 cm" line with one end labeled no pain and other end labeled worst intolerable pain. The patients marked the line at the point that best describing the pain intensity. The preoperative assessment included training of the patients about (VAS) for postoperative pain. The length of the line to the patient's mark will be measured and recorded postoperative after 30 min., 4, 6, 8, and 24 hours.If the VAS level is 5 or more this means failure of analgesio and a dose of rescue analgesia is given
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Dec 2018
- Primary completion1 Jun 2019
- Study completion10 Jul 2019
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalia Ismail
- Sponsor type
- University, hospital or other
- Collaborators
- Abdelhamid, Bassant Mohamed, M.D.
- Responsible party
- Sponsor-investigator, Dalia Ismail, Cairo University
- Investigators
- Bassant M Abdelhamid, MD, Principal investigator, Cairo UniversityDalia Khaled, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747406
- Sponsor's protocol ID
- N-125-2018
- Status last verified
- Dec 2019
- First submitted
- 14 Nov 2018
- Last updated
- 26 Dec 2019
- 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 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound-guided Erector Spinae Block and Transverse Abdominis Plane Block in Obese Patients Undergoing Sleeve Gasterectomy.
- ClinicalTrials.gov ID
- NCT03747406
- Acronym / sponsor ID
- N-125-2018
- Conditions
- Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Dalia IsmailUniversity, hospital or other
- Collaborators
- Abdelhamid, Bassant Mohamed, M.D.
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 20 Nov 2018 (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.
assess the efficacy of ultrasound guided erector spinae block to decrease the requirement for analgesics after laparoscopic sleeve gastrectomy and to decrease postoperative pain scores and opioid consumption compared to subcostal transverses abdominis block.
Detailed description
Primary outcomes
- Cumulative opioid consumption during the first 24 h postoperatively. For the purpose of comparison, all opioids administered postoperatively will be converted to IV morphine equivalent doses using standard opioid dosage conversion tables.
Secondary outcome parameters
- Pain assessment by the aid of Visual analogue scale (VAS), which is consisted of a "10 cm" line with one end labeled no pain and other end labeled worst intolerable pain. The patients marked the line at the point that best describing the pain intensity. The preoperative assessment included training of the patients about (VAS) for postoperative pain. The length of the line to the patient's mark will be measured and recorded postoperative after 30 min., 4, 6, 8, and 24 hours.
- Failure rate of the block will be calculated, where the block will be considered a failed block if the patient requires more than two doses of rescue analgesia in the first hour postoperatively.
- Duration of surgery (from skin incision till skin closure) and general anesthesia (from induction of GA till extubation).
- Incidence of complications, such as: Nerve injury, Hematoma formation, LA toxicity, and intravascular injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESP group | Experimental | Procedure: Erector spinae plane blockThe patient rolled to his side, the level between T9 and T10 identified using ultrasound. An 8-14 MHz curved array probe (Siemens ACUSON X300 Ultrasound System) will be applied longitudinal orientation 3 cm lateral midline. The erector spinae and the psoas muscle will be identified. A skin wheal will be made using lidocaine 1% at each level and then a 22-gauge, 8 cm Tuohy needle (Perifix Epidural Needle) will be advanced inplane until contact with the transverse process. The needle will be withdrawn slightly and 30cc of bupivacaine 0.25 % (15ml for each side) will be injected slowly after negative aspiration confirmed. The same procedure will be repeated in the contralateral side. |
| TAP group | Experimental | Procedure: TAP blockThe patient in supine position. Under complete aseptic conditions, a linear array transducer 5-12 MHz (Siemens ACUSON X300 Ultrasound System) will be positioned inferior and parallel to the costal margin in a medio-lateral orientation. The external oblique, internal oblique and transverse abdominis muscles will be identified immediately lateral to the linea semilunaris. A a 22-gauge, 8 cm Tuohy needle (Perifix Epidural Needle) will be advanced medially and in-plane to the US beam until the tip lies between the fascia of the internal oblique muscle and the transverse abdominis muscle layers. 30 ml of 0.25 % bupivacaine will be injected in each side and the spread will be observed between the two muscles layers. |
| opioid group | No intervention | –will receive intravenous morphine with general anesthesia and total opioid consumption will be calculated |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Patients from 18 to 59 years.
Key exclusion criteria (9 listed)
- • Patient refusal.
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 blockthe level between T9 and T10 will be identified using ultrasound as well as transverse processes depth. An array probe will be applied longitudinal orientation 3 cm lateral midline. The erector spinae and the psoas muscle will be identified. A skin wheal will be made using lidocaine 1% at each level and then a 22-gauge Tuohy needle will be advanced inplane until it made contact with the transverse process. The needle will be withdrawn slightly and 30cc of bupivacaine 0.25 % (15ml for each side) will be injected slowly after negative aspiration was confirmed. The same procedure will be repeated in the contralateral side. | Procedure or surgery | ESP group |
| TAP blocka linear array transducer 5-12 MHz will be positioned inferior and parallel to the costal margin in a medio-lateral orientation. The external oblique, internal oblique and transverse abdominis muscles will be identified immediately lateral to the linea semilunaris. A a 22-gauge needle will be advanced medially and in-plane to the US beam until the tip lies between the fascia of the internal oblique muscle and the transverse abdominis muscle layers. 30 ml of 0.25 % bupivacaine will be injected in each side and the spread will be observed between the two muscles layers. | Procedure or surgery | TAP group |
Primary outcome
Cumulative opioid consumption during the first 24 h postoperatively
Time frame: 24 hours after surgery
measure total opioid dose in 24 hours after surgery
1 secondary outcome
pain assessment by Visual Analog Scale
Time frame: 24 hours after surgery
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 26 Dec 2019.
- 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.
Bassant M Abdelhamid, MD principal investigator
Cairo University
Dalia Khaled, MD study director
Cairo 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 TAP block in people with Bariatric Surgery Candidate, run by Dalia Ismail 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 5 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: finished, as of the sponsor's last update on 26 Dec 2019. 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?
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?
Cumulative opioid consumption during the first 24 h postoperatively (time frame: 24 hours after surgery). 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 26 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.