Postoperative Pain ReliefESPBbariatricsNCT06812364
Bilateral Thorathic Erector Spinae Plane Block in Laparoscopic Bariatic Surgeries
An observational study of Postoperative Pain Relief, run by Cairo University at 1 site in Egypt.
Trial summary
The study is to evaluate effectiveness of one-level versus two-level thoracic ESP block on intraoperative and postoperative analgesia in bariatric surgeries and to compare total opioid consumption of both groups. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain Relief
- What is being tested?
- one level ESPB and two level ESPB
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 20 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: included Patient age will range 18 to 60 years, Body mass index(BMI) ≥ 35 - 50 kg/m2, American Society of Anesthesiologists physical status classes II to III, scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgeries, with normal coagulation profile, npt allergic to amide
Who may be able to join
- Patient age ranges 18 to 60 years old
- Obese patients ; Body mass index(BMI) ≥ 35 - 50 kg/m2
- American Society of Anesthesiologists (13) physical status classes II to III
- Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgeries
Who cannot join
- • Refusal of regional block
- Patients with neurological, psychological disorders or those lacking cooperation.
- Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical hernia repair or those with history of previous bariatric surgery or obstructive sleep apnea.
- Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
- Patients with bleeding disorders defined as (INR >1.4) and/ or (platelet count <100,000/µL)
- Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
- Patients who are allergic to amide local anesthetics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
belal galal mostafa mohammed khater, dr contact
Egypt1 site
Faculty of Medecine Cairo Uneversity
Cairo
kasr alainy, faculty of medecine
About this study
Official title: COMPARISON OF THE EFFICACY OF ONE LEVEL AND TWO LEVEL OF BILATERAL THORACIC ERECTOR SPINAE PLANE BLOCK COMBINED WITH GENERAL ANESTHESIA IN LAPAROSCOPIC BARIATRIC SURGERY FOR OBESE PATIENTS: RANDOMIZED CONTROLLED TRIAL
The study is to evaluate effectiveness of one-level versus two-level thoracic ESP block on intraoperative and postoperative analgesia in bariatric surgeries and to compare total opioid consumption of both groups.
Read the detailed description
The prevalence of overweight and obesity is steadily increasing. The epidemic of overweight and obesity presents a major challenge to chronic disease prevention and health across the life course around the world.
Bariatric surgery has proved to be an efficient intervention in the management of obesity. As a result, the number of post-bariatric surgery patients in the population is growing .
Postoperative pain is categorized into acute pain which occur immediately after surgery (up to 7 days) and chronic pain which lasts more than 3 months after the injury . Laparoscopic bariatric surgery often presents significant pain, ranging from moderate to severe, particularly in the immediate time following the operation, it is estimated that 75% of patients experience moderate pain post laparoscopic bariatric surgeries .
Postoperative pain is divided into four types according to cause, Nociceptive Pain is the signal of tissue irritation, impending injury, or actual injury. Neuropathic Pain is the result of the nervous system injury or malfunction, either in the peripheral or in the central nervous system, Psychogenic Pain due to the psychological factors leading to an exaggerated or histrionic presentation of the pain problem, Mixed Category Pain is caused by a complex mixture of nociceptive and neuropathic factors .
Due to the higher risk of respiratory depression, administering opioids to morbidly obese individuals might provide significant challenges when it comes to delivering pain relief .
Acetaminophen is widely considered the cornerstone of perioperative analgesia in the general surgical population.it has been supported by studies and experience in bariatric centers .
Non-steroidal anti-inflammatory drugs (NSAIDs) are components of foundational analgesia for nociceptive pain, which contribute to additional excellent opioid-sparing analgesia. The well-known perioperative concerns with NSAIDs (nephrotoxicity, gastrointestinal (GI) ulceration, and increased bleeding risk) are less likely with cyclooxygenase-2 (COX-2) inhibitors .
Perioperative tramadol side effects in the bariatric surgical population include increased postoperative nausea and vomiting (PONV), serotonin syndrome-inducing interactions (with anti-depressants), and more non-specific intolerance. Despite these, tramadol has been found useful in postoperative pain management after bariatric surgery.
The erector spinae plane block (ESPB) is a kind of paraspinal fascial plane block, which was initially described by Forero et al., (2016). The administration of local anesthetic (LA) occurs in the space between the thoracic transverse processes and the erector spinae muscle. This technique blocks the dorsal and ventral rami of the thoracic and abdominal spinal nerves, resulting in both somatic and visceral sensory blockade. This can potentially provide effective pain relief after abdominal surgery.
ESPB is effective, easy to perform, and can be performed in short time.(13) BUT there is no clear consensus in the studies conducted to determine the optimal level that can be achieved with volume expansion.
Previous reports have mentioned the analgesic effectiveness of one level ESPB in bariatric surgery, but this is the first randomized clinical trial to evaluate the feasibility, efficacy, and safety of two-level bilateral Erector Spinae Plane Block compared to one level in bariatric surgeries.
- Conditions
- Postoperative Pain Relief
- Being tested
- one level ESPB, two level ESPB
- Keywords
- one level ESPB, two level ESPB, bariatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one level ESPBProcedure or surgery
Ultrasound will be sagittal placed against the target vertebral level T7 vertebrae in the lateral or sitting position and moved in approximately 3-cm lateral to the spinous process. The Erector Spinae muscle and transverse process will be then identified, and a blunted tip ,100mm, 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be advanced, using the in-plane approach, in caudal -to- cephalad direction, through the inter fascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane, and on injection of 3 ml normal saline to confirm the correct needle tip position. The block will be performed bilaterally by injecting 60 mL of 0.25% bupivacaine (30mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the T7 vertebrae
two level ESPBProcedure or surgery
The target vertebral levels are T5 transverse process (at the level of Sternal Angle, above T7 by tow vertebra)(19) and T10 transverse process (at the level of Xiphisternal Junction, below T7 by 3 vertebrae).
The block will be performed bilaterally by injecting 60mL of 0.25% bupivacaine (15mL into each of four site) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the thoracic vertebrae 5 and 10 (at the most lateral part of the transverse process) in the same technique.
| Study group | Role | What they receive |
|---|---|---|
| One level ESPB | Ultrasound will be sagittal placed against the target vertebral level T7 vertebrae in the lateral or sitting position and moved in approximately 3-cm lateral to the spinous process. The Erector Spinae muscle and transverse process will be then identified, and a blunted tip ,100mm, 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be advanced, using the in-plane approach, in caudal -to- cephalad direction, through the inter fascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane, and on injection of 3 ml normal saline to confirm the correct needle tip position. The block will be performed bilaterally by injecting 60 mL of 0.25% bupivacaine (30mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the T7 vertebrae Receives: Procedure: one level ESPB | |
| two level ESPB | The target vertebral levels are T5 transverse process (at the level of Sternal Angle, above T7 by tow vertebra) and T10 transverse process (at the level of Xiphisternal Junction, below T7 by 3 vertebrae).
The block will be performed bilaterally by injecting 60mL of 0.25% bupivacaine (15mL into each of four site) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the thoracic vertebrae 5 and 10 (at the most lateral part of the transverse process) in the same technique Receives: Procedure: two level ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Comparison of mean visual analog scale scores at 24 hours postoperative between study groups
Measured: 24 hours
Secondary outcomes (3)
Time for first rescue analgesia in both groups
Measured: 24 hours
b) Total opioid consumption in both groups in 24hr postoperative
Measured: 24 hours
Failure rate in performing the block
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 posted6 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ReliefStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belal Galal Mostafa Mohammed Khater, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812364
- Sponsor's protocol ID
- MD-407-2024
- Acronym
- ESPBbariatrics
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE EFFICACY OF ONE LEVEL AND TWO LEVEL OF BILATERAL THORACIC ERECTOR SPINAE PLANE BLOCK COMBINED WITH GENERAL ANESTHESIA IN LAPAROSCOPIC BARIATRIC SURGERY FOR OBESE PATIENTS: RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT06812364
- Acronym / sponsor ID
- ESPBbariatrics / MD-407-2024
- Conditions
- Postoperative Pain Relief
- Keywords
- one level ESPB, two level ESPB, bariatric surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 6 Feb 2025 (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.
The study is to evaluate effectiveness of one-level versus two-level thoracic ESP block on intraoperative and postoperative analgesia in bariatric surgeries and to compare total opioid consumption of both groups.
Detailed description
The prevalence of overweight and obesity is steadily increasing. The epidemic of overweight and obesity presents a major challenge to chronic disease prevention and health across the life course around the world.
Bariatric surgery has proved to be an efficient intervention in the management of obesity. As a result, the number of post-bariatric surgery patients in the population is growing .
Postoperative pain is categorized into acute pain which occur immediately after surgery (up to 7 days) and chronic pain which lasts more than 3 months after the injury . Laparoscopic bariatric surgery often presents significant pain, ranging from moderate to severe, particularly in the immediate time following the operation, it is estimated that 75% of patients experience moderate pain post laparoscopic bariatric surgeries .
Postoperative pain is divided into four types according to cause, Nociceptive Pain is the signal of tissue irritation, impending injury, or actual injury. Neuropathic Pain is the result of the nervous system injury or malfunction, either in the peripheral or in the central nervous system, Psychogenic Pain due to the psychological factors leading to an exaggerated or histrionic presentation of the pain problem, Mixed Category Pain is caused by a complex mixture of nociceptive and neuropathic factors .
Due to the higher risk of respiratory depression, administering opioids to morbidly obese individuals might provide significant challenges when it comes to delivering pain relief .
Acetaminophen is widely considered the cornerstone of perioperative analgesia in the general surgical population.it has been supported by studies and experience in bariatric centers .
Non-steroidal anti-inflammatory drugs (NSAIDs) are components of foundational analgesia for nociceptive pain, which contribute to additional excellent opioid-sparing analgesia. The well-known perioperative concerns with NSAIDs (nephrotoxicity, gastrointestinal (GI) ulceration, and increased bleeding risk) are less likely with cyclooxygenase-2 (COX-2) inhibitors .
Perioperative tramadol side effects in the bariatric surgical population include increased postoperative nausea and vomiting (PONV), serotonin syndrome-inducing interactions (with anti-depressants), and more non-specific intolerance. Despite these, tramadol has been found useful in postoperative pain management after bariatric surgery.
The erector spinae plane block (ESPB) is a kind of paraspinal fascial plane block, which was initially described by Forero et al., (2016). The administration of local anesthetic (LA) occurs in the space between the thoracic transverse processes and the erector spinae muscle. This technique blocks the dorsal and ventral rami of the thoracic and abdominal spinal nerves, resulting in both somatic and visceral sensory blockade. This can potentially provide effective pain relief after abdominal surgery.
ESPB is effective, easy to perform, and can be performed in short time.(13) BUT there is no clear consensus in the studies conducted to determine the optimal level that can be achieved with volume expansion.
Previous reports have mentioned the analgesic effectiveness of one level ESPB in bariatric surgery, but this is the first randomized clinical trial to evaluate the feasibility, efficacy, and safety of two-level bilateral Erector Spinae Plane Block compared to one level in bariatric surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One level ESPB | – | Procedure: one level ESPBUltrasound will be sagittal placed against the target vertebral level T7 vertebrae in the lateral or sitting position and moved in approximately 3-cm lateral to the spinous process. The Erector Spinae muscle and transverse process will be then identified, and a blunted tip ,100mm, 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be advanced, using the in-plane approach, in caudal -to- cephalad direction, through the inter fascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane, and on injection of 3 ml normal saline to confirm the correct needle tip position. The block will be performed bilaterally by injecting 60 mL of 0.25% bupivacaine (30mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the T7 vertebrae |
| two level ESPB | – | Procedure: two level ESPBThe target vertebral levels are T5 transverse process (at the level of Sternal Angle, above T7 by tow vertebra) and T10 transverse process (at the level of Xiphisternal Junction, below T7 by 3 vertebrae). The block will be performed bilaterally by injecting 60mL of 0.25% bupivacaine (15mL into each of four site) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the thoracic vertebrae 5 and 10 (at the most lateral part of the transverse process) in the same technique |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- included Patient age will range 18 to 60 years, Body mass index(BMI) ≥ 35 - 50 kg/m2, American Society of Anesthesiologists physical status classes II to III, scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgeries, with normal coagulation profile, npt allergic to amide
Key inclusion criteria (4 listed)
- Patient age ranges 18 to 60 years old
- Obese patients ; Body mass index(BMI) ≥ 35 - 50 kg/m2
- American Society of Anesthesiologists (13) physical status classes II to III
- Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgeries
Key exclusion criteria (7 listed)
- • Refusal of regional block
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 |
|---|---|---|
| one level ESPBUltrasound will be sagittal placed against the target vertebral level T7 vertebrae in the lateral or sitting position and moved in approximately 3-cm lateral to the spinous process. The Erector Spinae muscle and transverse process will be then identified, and a blunted tip ,100mm, 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be advanced, using the in-plane approach, in caudal -to- cephalad direction, through the inter fascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane, and on injection of 3 ml normal saline to confirm the correct needle tip position. The block will be performed bilaterally by injecting 60 mL of 0.25% bupivacaine (30mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the T7 vertebrae | Procedure or surgery | One level ESPB |
| two level ESPBThe target vertebral levels are T5 transverse process (at the level of Sternal Angle, above T7 by tow vertebra)(19) and T10 transverse process (at the level of Xiphisternal Junction, below T7 by 3 vertebrae). The block will be performed bilaterally by injecting 60mL of 0.25% bupivacaine (15mL into each of four site) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the thoracic vertebrae 5 and 10 (at the most lateral part of the transverse process) in the same technique. | Procedure or surgery | two level ESPB |
Primary outcome
• Comparison of mean visual analog scale scores at 24 hours postoperative between study groups
Time frame: 24 hours
3 secondary outcomes
Time for first rescue analgesia in both groups
Time frame: 24 hours
b) Total opioid consumption in both groups in 24hr postoperative
Time frame: 24 hours
Failure rate in performing the block
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- 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.
belal galal mostafa mohammed khater, dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain Relief, 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 4 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: opening soon, as of the sponsor's last update on 6 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact belal galal mostafa mohammed khater, dr (00201006540407, bilal.j.khater@students.kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Comparison of mean visual analog scale scores at 24 hours postoperative between study groups (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 6 Feb 2025.