Pulmonary AtelectasisPhase 3NCT06695858
The Incidence of Post-Operative Lung Atelectasis With Erector Spinae Plane Block in Bariatric Surgery:
A Phase 3 study testing ESPB in people with Pulmonary Atelectasis and Bariatric Surgery, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
We aim to compare the incidence of post-operative lung atelectasis with erector spinae plane block versus systemic analgesia in patients undergoing bariatric surgery Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary Atelectasis, Bariatric Surgery
- What is being tested?
- ESPB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2024to 18 Oct 2025
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with body mass index ≥35 kg/m2
- scheduled to undergo laparoscopic bariatric surgery.
Who cannot join
- American Society of Anesthesiologists (ASA) physical class> III.
- Subjects with contraindications to peripheral regional anesthesia blocks
- neurological or psychological disorders
- inability to cooperate
- pre-existing chronic pain or cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incidence of Post-Operative Lung Atelectasis With Erector Spinae Plane Block in Bariatric Surgery: A Prospective Randomized Controlled Trial
We aim to compare the incidence of post-operative lung atelectasis with erector spinae plane block versus systemic analgesia in patients undergoing bariatric surgery
Read the detailed description
Patients will be randomly allocated at a 1:1 ratio into two groups, using a computer-generated random sequence and concealed envelopes that contained group assignments and drug preparation instructions.
Group I (control group): Patients received bilateral sham ultrasound-guided ESPB using 20 mL normal saline on each side.
Group II (ESPB group): Patients received bilateral ultrasound-guided ESPB using 20 mL bupivacaine 0.25% on each side.
An experienced anesthetist will open the envelopes, prepare the local anesthetics, and perform the assigned technique with no further involvement in the study.
A blinded investigator (an anesthesia and pain therapy specialist) will be responsible for perioperative data collection, pain assessment during the first 24 postoperative hours, and providing analgesia. All patients were blinded to the assigned technique.
Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 8 mg dexamethasone drugs. The study protocol, the numeric rating scale (NRS) of pain, and the use of patient-controlled analgesia (PCA) device will be explained to each participant during the preoperative anesthesia counseling.
Then patients will receive either ultrasound-guided bilateral ESPB or sham block according to their group allocation.
The severity of atelectasis will be evaluated by calculating the modified lung ultrasound score from Monastesse et al. [15], with scores between 0 and 3 (0=≤2 B lines; 1=≥3 B lines or multiple areas of subpleural consolidation separated by a normal pleural line; 2=multiple coalescent B lines, or multiple areas of subpleural consolidation separated by a thickened pleura; 3=consolidation or small areas of subpleural consolidation >1×2 cm in diameter (Supplementary Table 1). Lung ultrasound score 0 to 36 was estimated by summing the 12 individual quadrant scores. pulmonary atelectasis will be defined to be significant when the lung ultrasound score ≥2 in any region. We assumed that the lung ultrasound score on T4 can reflect the primary outcomes.
Anesthesia Dexamethasone (4mg to 8mg) will be given one hour before operation as a prophylaxis from nusea and vomiting.
Anesthesia will be induced with 2 mg/kg propofol, 2 mcg/kg fentanyl (lean body weight), and tracheal intubation will be facilitated by 0.6 mg/kg ideal body weight rocuronium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg rocuronium every 30 minutes. Arterial catheter will be inserted for blood sampling and invasive blood pressure monitoring.
Fluid management Intraoperative fluid management included a baseline infusion of crystalloids at the rate of 4 mL/kg/h and further fluid administration will be according to the attending anesthetist discretion aided by the pulse pressure variation in accordance with the local protocols of our hospital [16].
Ventilation All patients will receive volume control ventilation with tidal volume of 6-8 mL/kg of predicted body weight, positive end expiratory pressure (PEEP) of 5 cm H2O, fraction of inspired oxygen (FiO2) of 40%, and respiratory rate will be adjusted to maintain end-tidal CO2 of 30-40 mmHg. Surgery will be performed in reverse Trendelenburg position 30-40 degrees and the pneumoperitoneum will be standardized with an abdominal pressure at 12 cm H2O.
Intraoperative inadequate analgesia, indicated by increase of the heart rate (HR) or the mean arterial blood pressure (MAP) more than 20% above the baseline, will be managed using fentanyl 1 μg/kg. Intraoperative fentanyl consumption will be calculated.
Prevention of postoperative nausea and vomiting will be attempted using 4 mg ondansetron at the end of surgery. IV paracetamol 1g and ketorolac 30 mg will be administered to all patients 10 minutes before the end of surgery. 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 the post-anesthesia care unit (PACU). In the PACU, patients will be placed in the semi-sitting position, Postoperative pain will be assessed using NRS (where 0 corresponds to no pain and 10 to the worst pain) at PACU admission and 30 minutes, 1, 2, 4, 6, 8, 12, 18, and 24 hours postoperatively.
Criteria for intensive care unit (ICU) admission will be either respiratory-related, such as shortness of breath or desaturation (SpO2 < 90%), or non-respiratory-related, such as anastomotic leak or bleeding.
In PACU, bolus dose of morphine; 50mcg/kg will be given by the physician if pain score of the patient is more than 4. All patients with NRS ≤ 4 will receive morphine via an infusion pump (Zhejiang Fert disposable infusion pump 275ml with constant flow 5ml/hour. Zhejiang Fert Medical Device Co.,Ltd). Patients will receive a morphine continuous infusion of 10mcg/kg/hour (maximum 1 mg/hour). The patients will be instructed to report any pain to a pain nurse, and if the NRS increase to more than 4, the pain nurse will inform the anaesthesiologist. Inadequate analgesia (NRS more than 4) will be treated with a clinician bolus of 50mcg/kg with a time interval of 30 minutes at least between the additional doses till NRS decreases to less than 4 [17]. If the patient appeared sedated (Ramsay sedation scale > 2) [18].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, will be treated by stopping the pump until appropriate recovery and by a decrease in the demand dose of 20%.
Any intraoperative or postoperative complications were recorded. In case of vomiting, metoclopramide 10 mg will be given. Ondansetron 8mg will be given in persistent vomiting. In case of respiratory depression, Naloxone 1mcg/kg will be administered and oxygen will be supplied by oxygen mask. In case of decrease in MABP>20% from base line, the patient will receive a 500 ml ringer infusion with 5 mg ephedrine. If HR decrease to 45 beats/minute, atropine 0.5 mg will be given.
- Conditions
- Pulmonary Atelectasis, Bariatric Surgery
- Being tested
- ESPB
- Keywords
- Ultrasound, Erector spinae, Bariatric surgery, Atelectasis
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPBDrug
Patients received bilateral ultrasound-guided ESPB using 20 mL bupivacaine 0.25% on each side.
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | Patients received bilateral sham ultrasound-guided ESPB using 20 mL normal saline on each side. Receives: Drug: ESPB |
| ESPB group | Experimental | Patients received bilateral ultrasound-guided ESPB using 20 mL bupivacaine 0.25% on each side. Receives: Drug: ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung atelectasis
Lung atelectasis (defined as lung ultrasound score ≥2 in any lung region)
Measured: 6 hours
Secondary outcomes (1)
NRS
pain will be assessed using numerical rating score
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 posted19 Nov 2024
- Study start15 Nov 2024
- Primary completion18 Oct 2025
- Study completion18 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AtelectasisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695858
- Sponsor's protocol ID
- MD-271-2023
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Post-Operative Lung Atelectasis With Erector Spinae Plane Block in Bariatric Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06695858
- Acronym / sponsor ID
- MD-271-2023
- Conditions
- Pulmonary Atelectasis, Bariatric Surgery
- Keywords
- Ultrasound, Erector spinae, Bariatric surgery, Atelectasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 18 Oct 2025 (actual)
- Study completion
- 18 Oct 2025 (actual)
- First posted
- 19 Nov 2024 (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.
We aim to compare the incidence of post-operative lung atelectasis with erector spinae plane block versus systemic analgesia in patients undergoing bariatric surgery
Detailed description
Patients will be randomly allocated at a 1:1 ratio into two groups, using a computer-generated random sequence and concealed envelopes that contained group assignments and drug preparation instructions.
Group I (control group): Patients received bilateral sham ultrasound-guided ESPB using 20 mL normal saline on each side.
Group II (ESPB group): Patients received bilateral ultrasound-guided ESPB using 20 mL bupivacaine 0.25% on each side.
An experienced anesthetist will open the envelopes, prepare the local anesthetics, and perform the assigned technique with no further involvement in the study.
A blinded investigator (an anesthesia and pain therapy specialist) will be responsible for perioperative data collection, pain assessment during the first 24 postoperative hours, and providing analgesia. All patients were blinded to the assigned technique.
Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 8 mg dexamethasone drugs. The study protocol, the numeric rating scale (NRS) of pain, and the use of patient-controlled analgesia (PCA) device will be explained to each participant during the preoperative anesthesia counseling.
Then patients will receive either ultrasound-guided bilateral ESPB or sham block according to their group allocation.
The severity of atelectasis will be evaluated by calculating the modified lung ultrasound score from Monastesse et al. [15], with scores between 0 and 3 (0=≤2 B lines; 1=≥3 B lines or multiple areas of subpleural consolidation separated by a normal pleural line; 2=multiple coalescent B lines, or multiple areas of subpleural consolidation separated by a thickened pleura; 3=consolidation or small areas of subpleural consolidation >1×2 cm in diameter (Supplementary Table 1). Lung ultrasound score 0 to 36 was estimated by summing the 12 individual quadrant scores. pulmonary atelectasis will be defined to be significant when the lung ultrasound score ≥2 in any region. We assumed that the lung ultrasound score on T4 can reflect the primary outcomes.
Anesthesia Dexamethasone (4mg to 8mg) will be given one hour before operation as a prophylaxis from nusea and vomiting.
Anesthesia will be induced with 2 mg/kg propofol, 2 mcg/kg fentanyl (lean body weight), and tracheal intubation will be facilitated by 0.6 mg/kg ideal body weight rocuronium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg rocuronium every 30 minutes. Arterial catheter will be inserted for blood sampling and invasive blood pressure monitoring.
Fluid management Intraoperative fluid management included a baseline infusion of crystalloids at the rate of 4 mL/kg/h and further fluid administration will be according to the attending anesthetist discretion aided by the pulse pressure variation in accordance with the local protocols of our hospital [16].
Ventilation All patients will receive volume control ventilation with tidal volume of 6-8 mL/kg of predicted body weight, positive end expiratory pressure (PEEP) of 5 cm H2O, fraction of inspired oxygen (FiO2) of 40%, and respiratory rate will be adjusted to maintain end-tidal CO2 of 30-40 mmHg. Surgery will be performed in reverse Trendelenburg position 30-40 degrees and the pneumoperitoneum will be standardized with an abdominal pressure at 12 cm H2O.
Intraoperative inadequate analgesia, indicated by increase of the heart rate (HR) or the mean arterial blood pressure (MAP) more than 20% above the baseline, will be managed using fentanyl 1 μg/kg. Intraoperative fentanyl consumption will be calculated.
Prevention of postoperative nausea and vomiting will be attempted using 4 mg ondansetron at the end of surgery. IV paracetamol 1g and ketorolac 30 mg will be administered to all patients 10 minutes before the end of surgery. 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 the post-anesthesia care unit (PACU). In the PACU, patients will be placed in the semi-sitting position, Postoperative pain will be assessed using NRS (where 0 corresponds to no pain and 10 to the worst pain) at PACU admission and 30 minutes, 1, 2, 4, 6, 8, 12, 18, and 24 hours postoperatively.
Criteria for intensive care unit (ICU) admission will be either respiratory-related, such as shortness of breath or desaturation (SpO2 < 90%), or non-respiratory-related, such as anastomotic leak or bleeding.
In PACU, bolus dose of morphine; 50mcg/kg will be given by the physician if pain score of the patient is more than 4. All patients with NRS ≤ 4 will receive morphine via an infusion pump (Zhejiang Fert disposable infusion pump 275ml with constant flow 5ml/hour. Zhejiang Fert Medical Device Co.,Ltd). Patients will receive a morphine continuous infusion of 10mcg/kg/hour (maximum 1 mg/hour). The patients will be instructed to report any pain to a pain nurse, and if the NRS increase to more than 4, the pain nurse will inform the anaesthesiologist. Inadequate analgesia (NRS more than 4) will be treated with a clinician bolus of 50mcg/kg with a time interval of 30 minutes at least between the additional doses till NRS decreases to less than 4 [17]. If the patient appeared sedated (Ramsay sedation scale > 2) [18].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, will be treated by stopping the pump until appropriate recovery and by a decrease in the demand dose of 20%.
Any intraoperative or postoperative complications were recorded. In case of vomiting, metoclopramide 10 mg will be given. Ondansetron 8mg will be given in persistent vomiting. In case of respiratory depression, Naloxone 1mcg/kg will be administered and oxygen will be supplied by oxygen mask. In case of decrease in MABP>20% from base line, the patient will receive a 500 ml ringer infusion with 5 mg ephedrine. If HR decrease to 45 beats/minute, atropine 0.5 mg will be given.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Drug: ESPBPatients received bilateral sham ultrasound-guided ESPB using 20 mL normal saline on each side. |
| ESPB group | Experimental | Drug: ESPBPatients received bilateral ultrasound-guided ESPB using 20 mL bupivacaine 0.25% on each side. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients with body mass index ≥35 kg/m2
- scheduled to undergo laparoscopic bariatric surgery.
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists (ASA) physical class> III.
- Subjects with contraindications to peripheral regional anesthesia blocks
- neurological or psychological disorders
- inability to cooperate
- pre-existing chronic pain or cognitive dysfunction
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 |
|---|---|---|
| ESPBPatients received bilateral ultrasound-guided ESPB using 20 mL bupivacaine 0.25% on each side. | Drug | ESPB group, control group |
Primary outcome
Lung atelectasis
Time frame: 6 hours
Lung atelectasis (defined as lung ultrasound score ≥2 in any lung region)
1 secondary outcome
NRS
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 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ESPB in people with Pulmonary Atelectasis and Bariatric Surgery, run by Kasr El Aini Hospital 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 2 inclusion and 5 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 18 Nov 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lung atelectasis (time frame: 6 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 18 Nov 2025.