ObesityNCT04039321
Erector Spina Plane Block in Laparoscopic Sleeve Gastrectomy Surgery
A study testing ESPB group in people with Obesity, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the effect of erector spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- ESPB group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 4 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology (ASA) II-III
- 18-65 years
- body mass index (BMI) 40-60 kg/m2
- elective bariatric surgery
Who cannot join
- ASA ≥4
- under 18 years of age or over 65 years of age
- declining to give written informed consent
- have neurological and/or psychiatric disorders
- cooperation cannot be established
- accompanying laparoscopic cholecystectomy or paraumbilical hernia repair
Show all 12Show fewer
- history of bariatric surgery
- the block cannot be applied due to bleeding disorders or localized skin infection at the injection site
- with hepatic, neuromuscular, cardiac and/or renal failure
- history of allergy to the local anesthetics
- patients undergoing open surgery
- patients with severe obstructive or restrictive lung disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Antalya, 07100
About this study
Official title: The Effect of Erector Spina Plane Block on Pulmonary Functions and Analgesic Consumption in Laparoscopic Sleeve Gastrectomy Surgery
The aim of the study is to evaluate the effect of erector spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery.
Read the detailed description
Optimal pain management is very important in obese patients. In the postoperative period, narcotic analgesics are often used to pain management. However, the use of narcotic analgesics in the postoperative period causes many undesirable adverse effects, especially sedation, dizziness, constipation, nausea, vomiting, muscle rigidity, tolerance, and respiratory depression.
The morbidly obese patients treated with narcotic analgesics increased risk for adverse effects such as atelectasis, hypoxemia, and postoperative ileus. Consequently, these are caused postoperative pulmonary complications, hypoxemia and longer lenght of hospital stay. Multimodal analgesia including local and regional anesthesia is recommended for morbidly obese patients.
In recent years, the ultrasound (USG) guided ESP block has been frequently used to eliminate postoperative pain and reduce narcotic analgesic use. In the literature, it has been shown that bilateral USG guided ESP block provides effective analgesia and decrease the analgesia requirements after laparoscopic cholecystectomy. Some case series and case reports has also been reported that ESP block provides effective analgesia after abdominal and bariatric surgeries.
The aim of the study is to evaluate the effect of erector spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery. For this purpose, ASA II-III, patients over 18 years of age, BMI 40-60 kg/m2 and elective bariatric surgery planned patients will be included in the study.
- Conditions
- Obesity
- Being tested
- ESPB group, Control group
- Keywords
- Erector spina plane block, Laparoscopic sleeve gastrectomy, Obesity, Postoperative pain, Pulmonary functions
- Medical subject headings
- Obesity, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPB groupDrug
USG probe will be placed in a longitudinal parasagittal orientation 3 cm lateral to T7 spinous process. The erector spinae muscles will be identified hyperechoic transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 21-gauge 10-cm needle was inserted using an in-plane superior-to-inferior approach or an outplane approach. Following confirmation of the correct position of the needle with 5 ml normal saline, a dose of 20 ml %0.25 bupivacaine will be administered. The same procedure will be performed at the other site (totally 40 ml %0.25 bupivacaine). Standard pain follow up and monitorization will be performed.
Control groupDrug
The patients in this group will be performed no block. Standard pain follow up and monitorization will be performed.
| Study group | Role | What they receive |
|---|---|---|
| ESPB group | Active comparator | Before anaesthesia induction; bilateral ESP block will be performed under the guidance of USG. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. If patients' NRS score will ≥4/10, 100 mg IV tramadol will be performed. Receives: Drug: ESPB group |
| Control group | Sham comparator | Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. If patients' NRS score will ≥4/10, 100 mg IV tramadol will be performed. Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary function test
Pulmonary function test will be performed for all of them in the day before operation and 24 hours after the operation. Pulmonary function tests will assess via a portable spirometer with the patient in the sitting or semi-recumbent position.
Measured: perioperative
analgesia consumption
postoperative 24 hours
Measured: 24 hours
Secondary outcomes (2)
Postoperative Numeric Rating Scale (NRS) score
postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible). The NRS scores will be recorded at postoperative 0, 1, 3, 6, 9, 12, 18 and 24 hours
Measured: postoperative 0, 1, 3, 6, 9, 12, 18, 24 hours
arterial blood gases
intraoperative
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Aug 2019
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Arzu Karaveli, Antalya Training and Research Hospital
- Investigators
- Arzu Karaveli, Principal investigator, Antalya TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039321
- Sponsor's protocol ID
- 13/22
- Status last verified
- Dec 2019
- First submitted
- 27 Jul 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.
PubMed 28272292Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
PubMed 29913392
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Erector Spina Plane Block on Pulmonary Functions and Analgesic Consumption in Laparoscopic Sleeve Gastrectomy Surgery
- ClinicalTrials.gov ID
- NCT04039321
- Acronym / sponsor ID
- 13/22
- Conditions
- Obesity
- Keywords
- Erector spina plane block, Laparoscopic sleeve gastrectomy, Obesity, Postoperative pain, Pulmonary functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 31 Jul 2019 (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 aim of the study is to evaluate the effect of erector spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery.
Detailed description
Optimal pain management is very important in obese patients. In the postoperative period, narcotic analgesics are often used to pain management. However, the use of narcotic analgesics in the postoperative period causes many undesirable adverse effects, especially sedation, dizziness, constipation, nausea, vomiting, muscle rigidity, tolerance, and respiratory depression.
The morbidly obese patients treated with narcotic analgesics increased risk for adverse effects such as atelectasis, hypoxemia, and postoperative ileus. Consequently, these are caused postoperative pulmonary complications, hypoxemia and longer lenght of hospital stay. Multimodal analgesia including local and regional anesthesia is recommended for morbidly obese patients.
In recent years, the ultrasound (USG) guided ESP block has been frequently used to eliminate postoperative pain and reduce narcotic analgesic use. In the literature, it has been shown that bilateral USG guided ESP block provides effective analgesia and decrease the analgesia requirements after laparoscopic cholecystectomy. Some case series and case reports has also been reported that ESP block provides effective analgesia after abdominal and bariatric surgeries.
The aim of the study is to evaluate the effect of erector spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery. For this purpose, ASA II-III, patients over 18 years of age, BMI 40-60 kg/m2 and elective bariatric surgery planned patients will be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB group | Active comparator | Drug: ESPB groupBefore anaesthesia induction; bilateral ESP block will be performed under the guidance of USG. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. If patients' NRS score will ≥4/10, 100 mg IV tramadol will be performed. |
| Control group | Sham comparator | Drug: Control groupPatients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. If patients' NRS score will ≥4/10, 100 mg IV tramadol will be performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiology (ASA) II-III
- 18-65 years
- body mass index (BMI) 40-60 kg/m2
- elective bariatric surgery
Key exclusion criteria (12 listed)
- ASA ≥4
- under 18 years of age or over 65 years of age
- declining to give written informed consent
- have neurological and/or psychiatric disorders
- cooperation cannot be established
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 |
|---|---|---|
| ESPB groupUSG probe will be placed in a longitudinal parasagittal orientation 3 cm lateral to T7 spinous process. The erector spinae muscles will be identified hyperechoic transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 21-gauge 10-cm needle was inserted using an in-plane superior-to-inferior approach or an outplane approach. Following confirmation of the correct position of the needle with 5 ml normal saline, a dose of 20 ml %0.25 bupivacaine will be administered. The same procedure will be performed at the other site (totally 40 ml %0.25 bupivacaine). Standard pain follow up and monitorization will be performed. | Drug | ESPB group |
| Control groupThe patients in this group will be performed no block. Standard pain follow up and monitorization will be performed. | Drug | Control group |
Primary outcome
pulmonary function test
Time frame: perioperative
Pulmonary function test will be performed for all of them in the day before operation and 24 hours after the operation. Pulmonary function tests will assess via a portable spirometer with the patient in the sitting or semi-recumbent position.
analgesia consumption
Time frame: 24 hours
postoperative 24 hours
2 secondary outcomes
Postoperative Numeric Rating Scale (NRS) score
Time frame: postoperative 0, 1, 3, 6, 9, 12, 18, 24 hours
arterial blood gases
Time frame: during the 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 23 Dec 2019.
- Background: PubMed 28272292Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.
- Background: PubMed 29913392Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
- 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.
Arzu Karaveli principal investigator
Antalya TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESPB group in people with Obesity, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 12 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 23 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 Turkey (Türkiye). 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.
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?
pulmonary function test (time frame: perioperative). 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?
On the ClinicalTrials.gov record for NCT04039321, which also lists 2 linked publications.
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 23 Dec 2019.