Abdominal ObesityNCT06897345
Transversus Abdominis Plan Block Versus Rectus Sheath Block
A study testing transversus abdominis plane block and rectus sheat block in people with Abdominal Obesity and Postoperative Pain, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigator aims to compare the analgesic efficacy of Transversus Abdominis Plan Block and Rectus Sheath Block which are used to prevent intraoperative and postoperative pain and reduce the use of opioid in abdominoplasty operations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominal Obesity, Postoperative Pain, Postoperative Complications
- What is being tested?
- transversus abdominis plane block and rectus sheat block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients who will undergo elective abdominoplasty
- Patients between the ages of 18-65
- ASA (American Society of Anesthesiologists) I-II-III patients
- Patients with a body weight between 50-80 kg
Who cannot join
- - ASA IV patient group
- Patients under 18 years of age
- Patients without cooperation
- Patients with chronic alcohol use
- Patients in whom peripheral plane block application is contraindicated (infection at the application site, coagulopathy, local anesthetic allergy)
- Patients who do not want to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Training Hospital
Istanbul, 34371
MUSTAFA ALTINAY, 05333914422, m_altinay@yahoo.com
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Transversus Abdominis Plan Block and Rectus Sheath Block in Abdominoplasty Cases: A Randomized Prospective Clinical Trial
The investigator aims to compare the analgesic efficacy of Transversus Abdominis Plan Block and Rectus Sheath Block which are used to prevent intraoperative and postoperative pain and reduce the use of opioid in abdominoplasty operations.
Read the detailed description
Abdominoplasty is a frequently performed surgical procedure in aesthetic and plastic surgery. It is performed to solve the pain caused by the large abdomen, respiratory distress and aesthetic problems. Since large tissue excision is made and a large area is worked on, providing perioperative pain control is also important to prevent both postoperative respiratory distress and postoperative chronic pain formation.
In order to prevent both intraoperative and postoperative pain and to reduce opioid use, peripheral nerve blocks that provide analgesia on the abdominal wall can be applied to patients before the surgical incision. The most well-known of these blocks is the Transversus Abdominis Plane block. Another block that has been proven effective in abdominal surgery is the Rectus Sheath block. In the Transversus Abdominis Plane block (TAP), local anesthetic is injected into the fascia between the internal oblique and transversus abdominis muscles, aiming for analgesia. It provides multidermatomal sensory block by spreading the local anesthetic agent in the fascial area. The Rectus Sheath (RK) block is also a preferred plan block in abdominoplasty surgery. In this block, local anesthetic agent is injected between the rectus muscle and the posterior rectus sheath to achieve analgesia.
Although the effectiveness of both blocks has been shown mostly in abdominoplasty operations, there is no publication in the literature showing and comparing their effectiveness in abdominoplasty operations. With this study, The investigator aimed to compare the analgesic effectiveness of the two blocks in patients who will undergo abdominoplasty operations.
- Being tested
- transversus abdominis plane block, rectus sheat block
- Keywords
- post operative pain, transversus abdominis plane block, rectus sheat block
- Medical subject headings
- Obesity, Abdominal, Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transversus abdominis plane blockProcedure or surgery
Also called bupivakain
The transversus abdominis plane (TAP) block is a regional anesthesia technique used primarily to provide pain relief for patients undergoing surgery in the abdominal region. The TAP block targets the nerves that supply sensations to the skin and muscles of the abdominal wall.
rectus sheat blockProcedure or surgery
Also called bupivakain
The rectus sheath block is a type of regional anesthesia used primarily for pain management in the abdominal area. It involves injecting local anesthetic into the rectus sheath, which is the fibrous sheath that envelops the rectus abdominis muscle. This block targets the lower intercostal nerves as they traverse through the sheath, thereby providing analgesia to the anterior abdominal wall.
| Study group | Role | What they receive |
|---|---|---|
| transversus abdominis plane block | Active comparator | After administering 0.02 mg/kg midazolam for sedation to Group TAP patients, they will be placed in the supine position on both sides under sterile conditions using the high-frequency linear probe of the Esaote CA631 brand ultrasound, and the linear probe will be slid from the bilateral umblicus level to the midaxillary line, and when the internal and external oblique muscles are seen, the needle will be advanced from medial to lateral in an inplane manner, and the fascia between the internal oblique and transversus abdominis muscles will be reached, and after negative aspiration, 20 cc of 0.25% bubivacaine will be injected. Receives: Procedure: transversus abdominis plane block |
| rectus sheat block | Active comparator | After administering 0.02 mg/kg midazolam for sedation, in the supine position, under sterile conditions, using the high-frequency linear probe of the Esaote CA631 brand ultrasound, 1 cm laterally over the umblicus, and after negative aspiration between the rectus muscle and the posterior rectus sheath, 20 cc of 0.25% bubivacaine will be injected (bilateral). 15 minutes after the block is applied, general anesthesia will be applied to the patients in both groups with 1 mcg/kg fentanyl, 2 mg/kg propofol, 0.6 mg/kg rocuronium intravenously and they will be orotracheal intubated. Intraoperative remifentanil needs will be recorded. Within the scope of multimodal analgesia, 1 g paracetamol will be administered to all patients 30 minutes before the end of the operation and 3 mg/kg sugammadex will be administered at the end of the operation and they will be extubated. Receives: Procedure: rectus sheat block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The Visual Analog Scale (VAS) score is a subjective measurement tool used to assess the intensity of pain. It is commonly used in clinical settings to help patients communicate their pain levels to healthcare providers. The VAS typically consists of a straight line, often 10 centimeters long, with one end labeled "no pain" (0) and the other end labeled "worst pain imaginable" (10). Patients mark a point on the line that corresponds to their current level of pain.
Measured: VAS scores were measured at the beginning, st, 3rd, 6th, 12th and 24th hour in the postoperative recovery unit.
Secondary outcomes (2)
total analgesic consumption
Total analgesic consumption of patients in the first 24 hours postoperatively
Measured: 24 hour
first analgesic need
Time until first postoperative analgesic requirement
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysel Salkaya, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- LEYLA KILINC, Study chair, şişli etfal eğitim araştırma hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897345
- Sponsor's protocol ID
- salkaya-1
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Transversus Abdominis Plan Block and Rectus Sheath Block in Abdominoplasty Cases: A Randomized Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06897345
- Acronym / sponsor ID
- salkaya-1
- Keywords
- post operative pain, transversus abdominis plane block, rectus sheat block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 26 Mar 2025 (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 investigator aims to compare the analgesic efficacy of Transversus Abdominis Plan Block and Rectus Sheath Block which are used to prevent intraoperative and postoperative pain and reduce the use of opioid in abdominoplasty operations.
Detailed description
Abdominoplasty is a frequently performed surgical procedure in aesthetic and plastic surgery. It is performed to solve the pain caused by the large abdomen, respiratory distress and aesthetic problems. Since large tissue excision is made and a large area is worked on, providing perioperative pain control is also important to prevent both postoperative respiratory distress and postoperative chronic pain formation.
In order to prevent both intraoperative and postoperative pain and to reduce opioid use, peripheral nerve blocks that provide analgesia on the abdominal wall can be applied to patients before the surgical incision. The most well-known of these blocks is the Transversus Abdominis Plane block. Another block that has been proven effective in abdominal surgery is the Rectus Sheath block. In the Transversus Abdominis Plane block (TAP), local anesthetic is injected into the fascia between the internal oblique and transversus abdominis muscles, aiming for analgesia. It provides multidermatomal sensory block by spreading the local anesthetic agent in the fascial area. The Rectus Sheath (RK) block is also a preferred plan block in abdominoplasty surgery. In this block, local anesthetic agent is injected between the rectus muscle and the posterior rectus sheath to achieve analgesia.
Although the effectiveness of both blocks has been shown mostly in abdominoplasty operations, there is no publication in the literature showing and comparing their effectiveness in abdominoplasty operations. With this study, The investigator aimed to compare the analgesic effectiveness of the two blocks in patients who will undergo abdominoplasty operations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transversus abdominis plane block | Active comparator | Procedure: transversus abdominis plane blockAfter administering 0.02 mg/kg midazolam for sedation to Group TAP patients, they will be placed in the supine position on both sides under sterile conditions using the high-frequency linear probe of the Esaote CA631 brand ultrasound, and the linear probe will be slid from the bilateral umblicus level to the midaxillary line, and when the internal and external oblique muscles are seen, the needle will be advanced from medial to lateral in an inplane manner, and the fascia between the internal oblique and transversus abdominis muscles will be reached, and after negative aspiration, 20 cc of 0.25% bubivacaine will be injected. |
| rectus sheat block | Active comparator | Procedure: rectus sheat blockAfter administering 0.02 mg/kg midazolam for sedation, in the supine position, under sterile conditions, using the high-frequency linear probe of the Esaote CA631 brand ultrasound, 1 cm laterally over the umblicus, and after negative aspiration between the rectus muscle and the posterior rectus sheath, 20 cc of 0.25% bubivacaine will be injected (bilateral). 15 minutes after the block is applied, general anesthesia will be applied to the patients in both groups with 1 mcg/kg fentanyl, 2 mg/kg propofol, 0.6 mg/kg rocuronium intravenously and they will be orotracheal intubated. Intraoperative remifentanil needs will be recorded. Within the scope of multimodal analgesia, 1 g paracetamol will be administered to all patients 30 minutes before the end of the operation and 3 mg/kg sugammadex will be administered at the end of the operation and they will be extubated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who will undergo elective abdominoplasty
- Patients between the ages of 18-65
- ASA (American Society of Anesthesiologists) I-II-III patients
- Patients with a body weight between 50-80 kg
Key exclusion criteria (6 listed)
- - ASA IV patient group
- Patients under 18 years of age
- Patients without cooperation
- Patients with chronic alcohol use
- Patients in whom peripheral plane block application is contraindicated (infection at the application site, coagulopathy, local anesthetic allergy)
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 |
|---|---|---|
| transversus abdominis plane blockAlso: bupivakainThe transversus abdominis plane (TAP) block is a regional anesthesia technique used primarily to provide pain relief for patients undergoing surgery in the abdominal region. The TAP block targets the nerves that supply sensations to the skin and muscles of the abdominal wall. | Procedure or surgery | transversus abdominis plane block |
| rectus sheat blockAlso: bupivakainThe rectus sheath block is a type of regional anesthesia used primarily for pain management in the abdominal area. It involves injecting local anesthetic into the rectus sheath, which is the fibrous sheath that envelops the rectus abdominis muscle. This block targets the lower intercostal nerves as they traverse through the sheath, thereby providing analgesia to the anterior abdominal wall. | Procedure or surgery | rectus sheat block |
Primary outcome
Visual Analog Scale
Time frame: VAS scores were measured at the beginning, st, 3rd, 6th, 12th and 24th hour in the postoperative recovery unit.
The Visual Analog Scale (VAS) score is a subjective measurement tool used to assess the intensity of pain. It is commonly used in clinical settings to help patients communicate their pain levels to healthcare providers. The VAS typically consists of a straight line, often 10 centimeters long, with one end labeled "no pain" (0) and the other end labeled "worst pain imaginable" (10). Patients mark a point on the line that corresponds to their current level of pain.
2 secondary outcomes
total analgesic consumption
Time frame: 24 hour
first analgesic need
Time frame: 24 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- 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.
LEYLA KILINC study chair
şişli etfal eğitim araştırma hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transversus abdominis plane block and rectus sheat block in people with Abdominal Obesity and Postoperative Pain, run by Sisli Hamidiye Etfal 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 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: opening soon, as of the sponsor's last update on 26 Mar 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AYSEL SALKAYA (+905062046172, ayselsalkaya34@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: VAS scores were measured at the beginning, st, 3rd, 6th, 12th and 24th hour in the postoperative recovery unit.). 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 26 Mar 2025.