Bariatric Surgical ProceduresNCT06201546
Comparison of Abdominal Plane Blocks in Postoperative Pain Control in Patients Undergoing LSG
A study testing TAP block group and m-TAPA block group in people with Bariatric Surgical Procedures and Anesthesia and Analgesia, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this prospective observational study is compare in terms of efficiency and complications transversus abdominis plane (TAP) and Modified thoracoabdominal plane block-perichondrial approach (M-TAPA) blocks in patients undergoing laparoscopic sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgical Procedures, Anesthesia and Analgesia, Anesthesia, Regional
- What is being tested?
- TAP block group and m-TAPA block group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2023to 30 May 2023
- 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
- Patients between the ages of 18-65, including the ASA I-III group, who underwent laparoscopic sleeve gastrectomy by the General Surgery clinic between January 26, 2023 and May 15, 2023
Who cannot join
- Patients with coronary artery disease
- Patients with cerebrovascular disease
- Patients with peripheral artery disease
- History of chronic analgesic use
- Patients with coagulopathy
- Patients not between the ages of 18-65
- Patients with hepatic and/or renal insufficiency
- Patients with missing information in the information form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Abdominal Plane Blocks in Terms of Efficiency and Complications in Postoperative Pain Control in Patients Undergoing Laparoscopic Sleeve Gastrectomy
The goal of this prospective observational study is compare in terms of efficiency and complications transversus abdominis plane (TAP) and Modified thoracoabdominal plane block-perichondrial approach (M-TAPA) blocks in patients undergoing laparoscopic sleeve gastrectomy. The investigators aims to examine whether M-TAPA block provides more effective analgesia than TAP block in upper abdomen surgeries, and whether there is any difference in terms of nausea- vomiting and need for additional analgesics. The participitans will be observed for postoperative 24 hours with numeric rating score (NRS), postoperative nausea-vomiting score (PNVS) and in terms of need for additional analgesic dose.
Read the detailed description
After laparoscopic sleeve gastrectomy, patients have pain due to surgery. Different analgesic methods are preferred for pain relief. One of the methods used for this purpose is regional anesthesia. Modified thoracoabdominal plane block-perichondrial approach (M-TAPA) and transversus abdominis plane (TAP) block are also plan blocks used for this purpose. TAP block is formed by injecting local anesthetic into the neurofacial space between the transversus abdominis muscle and the internal oblique muscle through the Petit triangle in the lumbar region. TAP block creates dermatomal sensory block in the lower, lower thoracic and upper lumbar abdominal afferents. It is thought that the modified thoracoabdominal plane block-perichondrial approach (M-TAPA), which is a block frequently used in upper abdomen surgeries in recent years, can provide effective analgesia in LSG surgeries. M-TAPA block is created by administering local anesthetic between the transverse abdominis muscle and the internal oblique muscle with a single injection under the costal cartilage under ultrasound guidance. With M-TAPA, analgesia can be provided in thoracic 4 and thoracic 11-12 dermatomes.
Blocking of T4-12 nerve endings may be required in LSG surgeries, since gastric innervation and thoracic inlets are located in the upper abdomen dermatomes. In studies, the use of M-TAPA block in upper abdominal surgeries may be effective in the management of analgesia in participants. In this study the investigators aimed that, compression in terms of efficiency and complications TAP and M-TAPA blocks, who is undergoing laparoscopic sleeve gastrectomy. The investigators aims to examine whether M-TAPA block provides more effective analjesia than TAP block in upper abdomen surgeries, and whether there is any difference in terms of nausea- vomiting and need for additional analgesics. After obtaining ethical committee approval (12.01.2023/1), between January 26, 2023, and May 15, 2024, 60 patients undergoing laparoscopic sleeve gastrectomy with American Society of Anesthesiologists (ASA) II-III status provide informed consent. Participants who are planing to receive M-TAPA block defines as Group M-TAPA, and those who receive TAP block defines as Group TAP, with 30 patients in each group.The participitans will be observed for postoperative 24 hours with numeric rating score (NRS), postoperative nausea-vomiting score (PNVS) and in terms of need for additional analgesic dose.
- Being tested
- TAP block group, m-TAPA block group
- Keywords
- LSG, TAP, m-TAPA, pain manangement, plane block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP block groupProcedure or surgery
TAP block will be administrated after LSG. In TAP block local anesthetic(%0,25 bupivacaine-20ml)will be administrated the between the transversus abdominis muscle and the internal abdominal muscle fascia.
m-TAPA block groupProcedure or surgery
m-TAPA block will be administrated after LSG. In m-TAPA block local anesthetic (0.25% bupivacaine-20ml) will be administrated between the transversus abdominis muscle and the internal abdominal muscle fascia under the costochondrial region
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Active comparator | Transversus Abdominal Plane Block aplied after LSG. In TAP block local anesthetic(%0,25 bupivacaine-20ml)will be administrated the between the transversus abdominis muscle and the internal abdominal muscle fascia. Receives: Procedure: TAP block group |
| m-TAPA block | Active comparator | Modified-Thoracoabdominal Plane Block-pericondrial approach aplied after LSG. In m-TAPA block local anesthetic (0.25% bupivacaine-20ml) will be administrated between the transversus abdominis muscle and the internal abdominal muscle fascia under the costochondrial region. Receives: Procedure: m-TAPA block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rate Score (NRS)
NRS is a 0 to 10 scale that describes pain from good to worst.
Measured: It will be evaluated with (which ), at PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours
Visual Analog Scale (VAS)
VAS is a 10-centimeter scale and is used to evaluate pain.
Measured: PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours
Pain Controlled Analgesia (PCA)
PCA is includes 300mg Tramadol/100 ml SF- no infusion, 5cc bolus, 15 minutes lock
Measured: PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours
Secondary outcomes (1)
postoperative nausea and vomiting scale (PNV)
PNV is a 0 to 4 scale that describes nausea and vomiting from good to worst.
Measured: It will be evaluated with nause and vomiting score at PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start25 Feb 2023
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgical ProceduresStudies 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
- Clinical trial in which two groups of participants who are applied two type plane blocks. Group A; TAP block and group B; m-TAPA block. Effectiveness of blocks will be followed by appliying Pain Controlled Analgesia(PCA) and with pain scales as Visual Analog Scale(VAS) and Numerating Rate Scale.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Nur Teke, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- arzu yıldırım ar, Study director, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201546
- Sponsor's protocol ID
- gamzenurteke-1
- Status last verified
- Dec 2023
- First submitted
- 25 Feb 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available.
PubMed 16418039McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.
PubMed 17179269McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.
PubMed 17961838
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Abdominal Plane Blocks in Terms of Efficiency and Complications in Postoperative Pain Control in Patients Undergoing Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT06201546
- Acronym / sponsor ID
- gamzenurteke-1
- Keywords
- LSG, TAP, m-TAPA, pain manangement, plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 11 Jan 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.
The goal of this prospective observational study is compare in terms of efficiency and complications transversus abdominis plane (TAP) and Modified thoracoabdominal plane block-perichondrial approach (M-TAPA) blocks in patients undergoing laparoscopic sleeve gastrectomy. The investigators aims to examine whether M-TAPA block provides more effective analgesia than TAP block in upper abdomen surgeries, and whether there is any difference in terms of nausea- vomiting and need for additional analgesics. The participitans will be observed for postoperative 24 hours with numeric rating score (NRS), postoperative nausea-vomiting score (PNVS) and in terms of need for additional analgesic dose.
Detailed description
After laparoscopic sleeve gastrectomy, patients have pain due to surgery. Different analgesic methods are preferred for pain relief. One of the methods used for this purpose is regional anesthesia. Modified thoracoabdominal plane block-perichondrial approach (M-TAPA) and transversus abdominis plane (TAP) block are also plan blocks used for this purpose. TAP block is formed by injecting local anesthetic into the neurofacial space between the transversus abdominis muscle and the internal oblique muscle through the Petit triangle in the lumbar region. TAP block creates dermatomal sensory block in the lower, lower thoracic and upper lumbar abdominal afferents. It is thought that the modified thoracoabdominal plane block-perichondrial approach (M-TAPA), which is a block frequently used in upper abdomen surgeries in recent years, can provide effective analgesia in LSG surgeries. M-TAPA block is created by administering local anesthetic between the transverse abdominis muscle and the internal oblique muscle with a single injection under the costal cartilage under ultrasound guidance. With M-TAPA, analgesia can be provided in thoracic 4 and thoracic 11-12 dermatomes.
Blocking of T4-12 nerve endings may be required in LSG surgeries, since gastric innervation and thoracic inlets are located in the upper abdomen dermatomes. In studies, the use of M-TAPA block in upper abdominal surgeries may be effective in the management of analgesia in participants. In this study the investigators aimed that, compression in terms of efficiency and complications TAP and M-TAPA blocks, who is undergoing laparoscopic sleeve gastrectomy. The investigators aims to examine whether M-TAPA block provides more effective analjesia than TAP block in upper abdomen surgeries, and whether there is any difference in terms of nausea- vomiting and need for additional analgesics. After obtaining ethical committee approval (12.01.2023/1), between January 26, 2023, and May 15, 2024, 60 patients undergoing laparoscopic sleeve gastrectomy with American Society of Anesthesiologists (ASA) II-III status provide informed consent. Participants who are planing to receive M-TAPA block defines as Group M-TAPA, and those who receive TAP block defines as Group TAP, with 30 patients in each group.The participitans will be observed for postoperative 24 hours with numeric rating score (NRS), postoperative nausea-vomiting score (PNVS) and in terms of need for additional analgesic dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical trial in which two groups of participants who are applied two type plane blocks. Group A; TAP block and group B; m-TAPA block. Effectiveness of blocks will be followed by appliying Pain Controlled Analgesia(PCA) and with pain scales as Visual Analog Scale(VAS) and Numerating Rate Scale.
| Arm | Type | Receives |
|---|---|---|
| TAP block | Active comparator | Procedure: TAP block groupTransversus Abdominal Plane Block aplied after LSG. In TAP block local anesthetic(%0,25 bupivacaine-20ml)will be administrated the between the transversus abdominis muscle and the internal abdominal muscle fascia. |
| m-TAPA block | Active comparator | Procedure: m-TAPA block groupModified-Thoracoabdominal Plane Block-pericondrial approach aplied after LSG. In m-TAPA block local anesthetic (0.25% bupivacaine-20ml) will be administrated between the transversus abdominis muscle and the internal abdominal muscle fascia under the costochondrial region. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between the ages of 18-65, including the ASA I-III group, who underwent laparoscopic sleeve gastrectomy by the General Surgery clinic between January 26, 2023 and May 15, 2023
Key exclusion criteria (8 listed)
- Patients with coronary artery disease
- Patients with cerebrovascular disease
- Patients with peripheral artery disease
- History of chronic analgesic use
- Patients with coagulopathy
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 |
|---|---|---|
| TAP block groupTAP block will be administrated after LSG. In TAP block local anesthetic(%0,25 bupivacaine-20ml)will be administrated the between the transversus abdominis muscle and the internal abdominal muscle fascia. | Procedure or surgery | TAP block |
| m-TAPA block groupm-TAPA block will be administrated after LSG. In m-TAPA block local anesthetic (0.25% bupivacaine-20ml) will be administrated between the transversus abdominis muscle and the internal abdominal muscle fascia under the costochondrial region | Procedure or surgery | m-TAPA block |
Primary outcome
Numeric Rate Score (NRS)
Time frame: It will be evaluated with (which ), at PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours
NRS is a 0 to 10 scale that describes pain from good to worst.
Visual Analog Scale (VAS)
Time frame: PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours
VAS is a 10-centimeter scale and is used to evaluate pain.
Pain Controlled Analgesia (PCA)
Time frame: PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours
PCA is includes 300mg Tramadol/100 ml SF- no infusion, 5cc bolus, 15 minutes lock
1 secondary outcome
postoperative nausea and vomiting scale (PNV)
Time frame: It will be evaluated with nause and vomiting score at PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th 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 4 Apr 2024.
- Background: PubMed 16418039O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available.
- Background: PubMed 17179269McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.
- Background: PubMed 17961838McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.
- 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 yıldırım ar study director
Fatih Sultan Mehmet 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 TAP block group and m-TAPA block group in people with Bariatric Surgical Procedures and Anesthesia and Analgesia, run by Fatih Sultan Mehmet 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 8 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 4 Apr 2024. 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. 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?
Numeric Rate Score (NRS) (time frame: It will be evaluated with (which ), at PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours). The study lists 3 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 NCT06201546, which also lists 3 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 4 Apr 2024.