Modified Thoracoabdominal Nerve Plane Block In Laparoscopic Sleeve Gastrectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstanbul Medipol University Hospital
About this trial
Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. Studies show that M-TAPA block is effective for postoperative analgesia and other abdominal surgeries, but its effect on patients undergoing LSG surgery has not yet been studied. The hypothesis is that the M-TAPA block performed in patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) Operation would reduce opioid consumption in the first 24 hours period after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
with a history of bleeding diathesis,
receiving anticoagulant treatment,
with allergies or sensitivity to drugs used,
with an infection on the puncture site
Trial design
Design model
Parallel
Treatments tested in this trial
M-TAPA block
Procedure/SurgeryAfter the wound closure is completed and the patient is still under genaral anesthesia the M-TAPA block ill be performed. As the patient is in the supine position, the high-frequency linear US probe (11-12 MHz, Vivid Q) and a 22-G 80-mm needle (Stimuplex® Ultra 360®, Braun, USA) will be placed in a sagittal position at the costochondral junction at the level of the 9th and 10th ribs. After the rib and the external oblique, internal oblique, and transversus abdominis muscles are visualized on USG, using an in-plane technique, the block needle will be advanced and the block location will be confirmed by injecting 5 ml of saline between the internal oblique and transversus abdominis muscles. Once the block location is confirmed, 30 ml of 0.25% bupivacaine (Buvicaine ®) will be applied on each side. The total volume will be 60 ml.
Postoperative pain management
Procedure/Surgeryibuprofen 400mg (Ibuprofen-PF®) intravenous (IV), and tramadol (Contramal®) 100 mg IV will be administered to all patients 20 minutes before wound closure. After surgery, Ibuprofen 400 mg will be given three times a day. A patient-controlled analgesia (PCA) system containing 10 mcg/ml fentanyl will be provided to all patients without continuous infusion. Patients can administer boluses of 0.35 mcg/kg with a 15-minute lockout period and a maximum dose of 100 mcg per hour. Another anesthesiologist will assess patients after surgery. If the patient's pain score (NRS) is 4 or higher, IV tramadol (Contramal®) 100 mg will be given as a rescue analgesic.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group M = M-TAPA Block groupExperimental treatment 2 interventions
Group B: Group K = control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Opioid consumption
The primary aim is to compare postoperative opioid consumption from the PCA device.
Time frame
Changes from baseline opioid consumption at postoperative 0, 2, 4, 8, 16, and 24 hoursSecondary outcomes
1
Pain scores
The secondary aim is to compare NRS at the postoperative 24 h. Postoperative pain assessment will be performed using the Numerical Rating Scale (NRS) (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded.
Time frame
Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours2
Need for rescue analgesia (tramadol)
The secondary aim is to compare rescue analgesia amount used in the postoperative 24 h period.
Time frame
Postoperative 24-hour period3
Adverse events
The secondary aim is to compare the adverse events (nausea, vomiting, itching, ect) related to opioid use
Time frame
Postoperative 24-hour periodSponsors and contacts
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Source ClinicalTrials.gov