ObesityNCT04189289
Laparoscopic Bariatric Surgery and Erector Spinae Plane Block
A study testing ESP block group in people with Obesity and Postoperative Pain, 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 spinae plane (ESP) block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Postoperative Pain, Bariatric Surgery
- What is being tested?
- ESP block group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2019to 6 Apr 2020
- 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
- elective bariatric surgery
- American Society of Anesthesiology (ASA) II-III
- 18 - 65 years
- body mass index (BMI) 40-60 kg/m2
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 11Show 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Antalya
About this study
Official title: Comparison of the Efficacy of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Bariatric Surgery
The aim of the study is to evaluate the effect of erector spinae plane (ESP) block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery
Read the detailed description
Laparoscopic sleeve gastrectomy is one of the most common surgical procedure that is chosen for bariatric surgery. Postoperative pain after bariatric surgery can de significant. Narcotic analgesics are often used to manage the postoperative pain in patients undergoing bariatric surgery. However, these drugs causes many undesirable adverse effects such as nausea, constipation, and respiratory depression.
The ultrasound (USG) guided ESP block was first defined in 2016. With the administration of local anesthesia between the transverse process of the vertebra and the erector spinae muscle, it is stated that the effect mechanism of ESP is that spread blocks the ventral and dorsal rami to the paravertebral area. In the literature, it has been shown that bilateral USG guided ESP block provides effective analgesia after bariatric surgery.
The aim of the study is to evaluate the effect of ESP block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery
- Conditions
- Obesity, Postoperative Pain, Bariatric Surgery
- Being tested
- ESP block group, Control group
- Keywords
- Erector spinae plane (ESP) block, Laparoscopic bariatric surgery, Obesity, Postoperative pain
- Medical subject headings
- Obesity, Pain, Postoperative, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP block groupProcedure or surgery
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 out-plane 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 groupProcedure or surgery
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 |
|---|---|---|
| ESP block 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. Standardized postoperative tramadol i.v. patient controlled analgesia (PCA) protocol will be performed (3 mg/ml, total volume 100 ml, 10 mg bolus dose, 20 min locked period, without continuous delivery, no basal infusion). Receives: Procedure: ESP block group |
| Control group | Sham comparator | Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. Standardized postoperative tramadol i.v. PCA analgesia protocol will be performed (3 mg/ml, total volume 100 ml, 10 mg bolus dose, 20 min locked period, without continuous delivery, no basal infusion). Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesia consumption
postoperative 24 hours
Measured: 24 hours
Secondary outcomes (1)
Postoperative Numeric Rating Scale (NRS) score
postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible).
Measured: postoperative 0, 1, 3, 6, 12, 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 Dec 2019
- Study start3 Dec 2019
- Primary completion3 Apr 2020
- Study completion6 Apr 2020
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Arzu Karaveli, Principal investigator, Antalya TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189289
- Sponsor's protocol ID
- 21/16
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 8 Apr 2020
- 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 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04189289
- Acronym / sponsor ID
- 21/16
- Conditions
- Obesity, Postoperative Pain, Bariatric Surgery
- Keywords
- Erector spinae plane (ESP) block, Laparoscopic bariatric surgery, Obesity, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 6 Dec 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 spinae plane (ESP) block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery
Detailed description
Laparoscopic sleeve gastrectomy is one of the most common surgical procedure that is chosen for bariatric surgery. Postoperative pain after bariatric surgery can de significant. Narcotic analgesics are often used to manage the postoperative pain in patients undergoing bariatric surgery. However, these drugs causes many undesirable adverse effects such as nausea, constipation, and respiratory depression.
The ultrasound (USG) guided ESP block was first defined in 2016. With the administration of local anesthesia between the transverse process of the vertebra and the erector spinae muscle, it is stated that the effect mechanism of ESP is that spread blocks the ventral and dorsal rami to the paravertebral area. In the literature, it has been shown that bilateral USG guided ESP block provides effective analgesia after bariatric surgery.
The aim of the study is to evaluate the effect of ESP block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised controlled
| Arm | Type | Receives |
|---|---|---|
| ESP block group | Active comparator | Procedure: ESP block 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. Standardized postoperative tramadol i.v. patient controlled analgesia (PCA) protocol will be performed (3 mg/ml, total volume 100 ml, 10 mg bolus dose, 20 min locked period, without continuous delivery, no basal infusion). |
| Control group | Sham comparator | Procedure: Control groupPatients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. Standardized postoperative tramadol i.v. PCA analgesia protocol will be performed (3 mg/ml, total volume 100 ml, 10 mg bolus dose, 20 min locked period, without continuous delivery, no basal infusion). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elective bariatric surgery
- American Society of Anesthesiology (ASA) II-III
- 18 - 65 years
- body mass index (BMI) 40-60 kg/m2
Key exclusion criteria (11 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 |
|---|---|---|
| ESP block 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 out-plane 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. | Procedure or surgery | ESP block group |
| Control groupThe patients in this group will be performed no block. Standard pain follow up and monitorization will be performed. | Procedure or surgery | Control group |
Primary outcome
analgesia consumption
Time frame: 24 hours
postoperative 24 hours
1 secondary outcome
Postoperative Numeric Rating Scale (NRS) score
Time frame: postoperative 0, 1, 3, 6, 12, 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 8 Apr 2020.
- 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 ESP block group in people with Obesity and Postoperative Pain, 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 11 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 8 Apr 2020. 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?
analgesia consumption (time frame: 24 hours). 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 NCT04189289, 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 8 Apr 2020.