Laparoscopic Bariatric SurgeryNCT05020379
The Effects of Erector Spinae Plane Block on Bariatric Surgery.
A study testing Perioperative and postoperative multimodal analgesia and ESP Block in people with Laparoscopic Bariatric Surgery, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The erector spinae plane block (ESPB) is a new technique that is increasingly used in the treatment of acute and chronic pain. Bariatric surgery is a surgical treatment method used in the treatment of morbid obesity and related comorbidities. Providing pain control in obese patients is a topic that remains up-to-date. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Bariatric Surgery
- What is being tested?
- Perioperative and postoperative multimodal analgesia and ESP Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2021to 27 Oct 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled for elective laparoscopic bariatric surgery
Who cannot join
- a history of allergy to local anesthetics
- known coagulation disorders
- infection near the puncture site
- Chronic opioid intake
- Patient with psychiatric disorders
- Can not communicate in Turkish
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman, 70200
About this study
Official title: Investigation of The Effects of The Erector Spinae Plane Block on The Quality Of Recovery After Laparoscopic Bariatric Surgery: A Prospective Randomized Trial
The erector spinae plane block (ESPB) is a new technique that is increasingly used in the treatment of acute and chronic pain. Bariatric surgery is a surgical treatment method used in the treatment of morbid obesity and related comorbidities. Providing pain control in obese patients is a topic that remains up-to-date. Poorly controlled early postoperative pain impairs quality of recovery, increases the risk of postoperative pulmonary complications, and is a risk factor for the subsequent development of chronic pain. Therefore, optimizing acute postoperative analgesia is a priority in patients undergoing bariatric surgery. The primary aim of this prospective, randomized study is to evaluate the effect of ESPB on quality of recovery with the QoR-40 questionnaire in patients undergoing elective Laparoscopic Bariatric Surgery.
Read the detailed description
In the operating room, all patients will receive standard monitoring, including electrocardiography, non-invasive blood pressure, and peripheral oxygen saturation. Patients in the ESPB group will be placed in a sitting position. A convex probe ultrasound transducer will be placed in a longitudinal parasagittal orientation approximately 3 cm lateral to the spinous process. The needle tip was advanced until it will be located in the inter-fascial plane deep to the erector spinae muscle group and superior to the transverse process. Once in position, bupivacaine 0.25%, 20 ml was injected under ultrasound, guidance. The same procedure will be repeated on the contralateral site. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be recorded on the 15th,30th minute, 1st, 2nd, 12th, 24th hour, 2nd day. Quality of recovery-40 (QoR-40) scores will be given on the ward, at postoperative 24th hour, 3rd and 7th day ( the 3rd and 7th-day scores will be calculated after telephone interview if the patient will be discharged from the hospital).
- Conditions
- Laparoscopic Bariatric Surgery
- Being tested
- Perioperative and postoperative multimodal analgesia, ESP Block
- Keywords
- Barıatrıc Surgery., Erector spinae block, Quality of recovery (QoR-40)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative and postoperative multimodal analgesiaProcedure or surgery
Also called Global Quality of Recovery-40 score, Standard Pain Follow up
Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol.
The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be evaluated at 15th and 30th minutes, 1st, 2nd, 6th, 12th, 24th hours, 2nd day.
ESP BlockProcedure or surgery
Also called Global Quality of Recovery-40 score, Standard Pain Follow up
Patients in the ESPB group will be placed in a sitting position. A convex probe ultrasound transducer will be placed in a longitudinal parasagittal orientation approximately 3 cm lateral to the spinous process. Local anesthetic (20 ml 0.25% bupivacaine) will be injected bilaterally into the fascial plane on the deep face of the erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be evaluated at 15th and 30th minutes, 1st, 2nd, 6th, 12th, 24th hours, 2nd day.
| Study group | Role | What they receive |
|---|---|---|
| Group N | Sham comparator | The patients in Group N will not receive any intervention. Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol. The pain intensity will be evaluated with the 0-10 Numeric Rating Scale (NRS). NRS are the simple and most commonly used scales.11 The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." Receives: Procedure: Perioperative and postoperative multimodal analgesia |
| Group ESPB | Experimental | The patients in the group ESPB will be placed in sitting pozition. A convex probe ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. Local anesthetic (20 ml 0.25% bupivacaine) will be injected bilaterally into the fascial plane on the deep aspect of erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical rating scale (NRS) Receives: Procedure: Perioperative and postoperative multimodal analgesia; Procedure: ESP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery (QoR-40) score
QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200. The increase in scores show high quality of recovery.
Measured: postoperative 24th hour
Secondary outcomes (7)
Postoperative pain: numeric rating scale (NRS)
NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain). Postoperative pain levels will be determined by Numeric Rating Scale (NRS) system
Measured: Postoperative 48 hour
Analgesic consumption
Total opioid consumption at the postoperative period
Measured: Postoperative 48 hour
Side effects
Rate of side-effect occurrences (such as rate of vomiting,nausea,dizziness)
Measured: 24 hours
Sedation score
Evaluation of the level of sedation in patients with a 4-point scale (0=wake, 1=sleepy, easy to verbally arouse, 2=drowsy, 3=does not open their eyes to verbal commands).
Measured: Postoperative 48 hour
mobilization time
The time after surgery to the mobilization of the patient
Measured: Postoperative 24 hour
Quality of Recovery (QoR-40) score
QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200. The increase in scores show high quality of recovery.
Measured: Postoperative 3rd and 7th days
Postoperative complications
Postoperative complications will be identified by visiting patients every day or alternate day during their in hospital course, suplemented by patients medical records using our hospital's electronic patient record database. We will use the Claviene Dindo Classification system from which CC is derived. We defined a postoperative complication as any deviation from the ideal postoperative course, not inherent in the procedure itself and does not constitute a failure to cure. CCI scores willbe calculated using the online CCI calculator.
Measured: Postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start10 Sep 2021
- Primary completion27 Sep 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Bariatric SurgeryStudies 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
- Model description
- Randomized Intervention Model: Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Betul Basaran, MD, DESA, Study director, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020379
- Sponsor's protocol ID
- 05-2021/05
- Status last verified
- Oct 2022
- First submitted
- 21 Aug 2021
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Toprak H, Basaran B, Toprak SS, Et T, Kumru N, Korkusuz M, Bilge A, Yarimoglu R. Efficacy of the Erector Spinae Plane Block for Quality of Recovery in Bariatric Surgery: a Randomized Controlled Trial. Obes Surg. 2023 Sep;33(9):2640-2651. doi: 10.1007/s11695-023-06748-3. Epub 2023 Jul 24.
PubMed 37488349
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Effects of The Erector Spinae Plane Block on The Quality Of Recovery After Laparoscopic Bariatric Surgery: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05020379
- Acronym / sponsor ID
- 05-2021/05
- Conditions
- Laparoscopic Bariatric Surgery
- Keywords
- Barıatrıc Surgery., Erector spinae block, Quality of recovery (QoR-40)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 25 Aug 2021 (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 erector spinae plane block (ESPB) is a new technique that is increasingly used in the treatment of acute and chronic pain. Bariatric surgery is a surgical treatment method used in the treatment of morbid obesity and related comorbidities. Providing pain control in obese patients is a topic that remains up-to-date. Poorly controlled early postoperative pain impairs quality of recovery, increases the risk of postoperative pulmonary complications, and is a risk factor for the subsequent development of chronic pain. Therefore, optimizing acute postoperative analgesia is a priority in patients undergoing bariatric surgery. The primary aim of this prospective, randomized study is to evaluate the effect of ESPB on quality of recovery with the QoR-40 questionnaire in patients undergoing elective Laparoscopic Bariatric Surgery.
Detailed description
In the operating room, all patients will receive standard monitoring, including electrocardiography, non-invasive blood pressure, and peripheral oxygen saturation. Patients in the ESPB group will be placed in a sitting position. A convex probe ultrasound transducer will be placed in a longitudinal parasagittal orientation approximately 3 cm lateral to the spinous process. The needle tip was advanced until it will be located in the inter-fascial plane deep to the erector spinae muscle group and superior to the transverse process. Once in position, bupivacaine 0.25%, 20 ml was injected under ultrasound, guidance. The same procedure will be repeated on the contralateral site. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be recorded on the 15th,30th minute, 1st, 2nd, 12th, 24th hour, 2nd day. Quality of recovery-40 (QoR-40) scores will be given on the ward, at postoperative 24th hour, 3rd and 7th day ( the 3rd and 7th-day scores will be calculated after telephone interview if the patient will be discharged from the hospital).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Intervention Model: Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Group N | Sham comparator | Procedure: Perioperative and postoperative multimodal analgesiaThe patients in Group N will not receive any intervention. Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol. The pain intensity will be evaluated with the 0-10 Numeric Rating Scale (NRS). NRS are the simple and most commonly used scales.11 The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." |
| Group ESPB | Experimental | Procedure: Perioperative and postoperative multimodal analgesia, Procedure: ESP BlockThe patients in the group ESPB will be placed in sitting pozition. A convex probe ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. Local anesthetic (20 ml 0.25% bupivacaine) will be injected bilaterally into the fascial plane on the deep aspect of erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical rating scale (NRS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for elective laparoscopic bariatric surgery
Key exclusion criteria (6 listed)
- a history of allergy to local anesthetics
- known coagulation disorders
- infection near the puncture site
- Chronic opioid intake
- Patient with psychiatric disorders
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 |
|---|---|---|
| Perioperative and postoperative multimodal analgesiaAlso: Global Quality of Recovery-40 score, Standard Pain Follow upPatients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol. The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be evaluated at 15th and 30th minutes, 1st, 2nd, 6th, 12th, 24th hours, 2nd day. | Procedure or surgery | Group ESPB, Group N |
| ESP BlockAlso: Global Quality of Recovery-40 score, Standard Pain Follow upPatients in the ESPB group will be placed in a sitting position. A convex probe ultrasound transducer will be placed in a longitudinal parasagittal orientation approximately 3 cm lateral to the spinous process. Local anesthetic (20 ml 0.25% bupivacaine) will be injected bilaterally into the fascial plane on the deep face of the erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be evaluated at 15th and 30th minutes, 1st, 2nd, 6th, 12th, 24th hours, 2nd day. | Procedure or surgery | Group ESPB |
Primary outcome
Quality of Recovery (QoR-40) score
Time frame: postoperative 24th hour
QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200. The increase in scores show high quality of recovery.
7 secondary outcomes
Postoperative pain: numeric rating scale (NRS)
Time frame: Postoperative 48 hour
Analgesic consumption
Time frame: Postoperative 48 hour
Side effects
Time frame: 24 hours
Sedation score
Time frame: Postoperative 48 hour
mobilization time
Time frame: Postoperative 24 hour
Quality of Recovery (QoR-40) score
Time frame: Postoperative 3rd and 7th days
Postoperative complications
Time frame: Postoperative 30 days
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 28 Oct 2022.
- Derived from this study: PubMed 37488349Toprak H, Basaran B, Toprak SS, Et T, Kumru N, Korkusuz M, Bilge A, Yarimoglu R. Efficacy of the Erector Spinae Plane Block for Quality of Recovery in Bariatric Surgery: a Randomized Controlled Trial. Obes Surg. 2023 Sep;33(9):2640-2651. doi: 10.1007/s11695-023-06748-3. Epub 2023 Jul 24.
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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.
Betul Basaran, MD, DESA study director
Karaman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative and postoperative multimodal analgesia and ESP Block in people with Laparoscopic Bariatric Surgery, run by Karaman 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 1 inclusion and 6 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 28 Oct 2022. 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?
Quality of Recovery (QoR-40) score (time frame: postoperative 24th hour). 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 NCT05020379, which also lists 1 linked publication.
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 28 Oct 2022.