Obesity, Bariatric Surgery, Laparoscopic Sleeve Gastrectomy, Acute Post Operative Pain
Conditions
Keywords
ModifiedThoracoabdominal Nerve Plane Block, Laparoscopic Sleeve Gastrectomy, Bariatric Surgery, Acute Postoperative Pain
Brief summary
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.
Detailed description
LSG is defined as first-line bariatric surgery for patients at high surgical risk with better surgical outcomes. Effective postoperative pain management is essential for early mobilization, and reduction of the risk of morbidity and mortality. Opioids, due to their potent analgesic effects are used as a component of multimodal analgesia in the postoperative period. Despite their advantages, opioids may be related to pulmonary complications such as atelectasis and impaired alveolar gas exchange, apnea; postoperative delayed recovery due to ileus, nausea, and vomiting; and prolonged hospital stay. The use of interfascial plane blocks for pain management has increased recently, as ultrasonography (USG) has become a part of daily routine. Interfascial plane blocks provide effective postoperative analgesia. Additionally, reducing postoperative opioid consumption helps to provide hemodynamic stability and promote early mobilization. Studies are showing M-TAPA block to be effective for postoperative analgesia for abdominal surgeries, and some studies continued comparing its effect in laparoscopic sleeve gastrectomy with other plane blocks. There are also case reports showing the effectiveness of the M-TAPA block in LSG patients. M-TAPA block's effect on LSG patients has not been studied yet. The investigators hypothesize that the M-TAPA block performed in patients undergoing laparoscopic sleeve gastrectomy would reduce opioid consumption in the first 24-hour period after surgery.
Interventions
PROCEDUREM-TAPA block
After 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.
PROCEDUREPostoperative pain management
ibuprofen 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.
Sponsors
Istanbul Medipol University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The outcomes assessor and participants will be blinded to the study.
Intervention model description
Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification II-III, scheduled for laparoscopic sleeve gastrectomy operation will be included in the study. Patients will be randomly divided into two groups (Group M=M-TAPA block group, Group K = control group) including 30 patients each, before entering the operating room.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
American Society of Anesthesiologists (ASA) classification II- III Patients Scheduled for LSG under general anesthesia \-
Exclusion criteria
Patients * with a history of bleeding diathesis, * receiving anticoagulant treatment, * with allergies or sensitivity to drugs used, * with an infection on the puncture site * with a history of alcohol or drug addiction, * with congestive heart failure * with liver or kidney disease * who do not accept the procedure or participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | Changes from baseline opioid consumption at postoperative 0, 2, 4, 8, 16, and 24 hours | The primary aim is to compare postoperative opioid consumption from the PCA device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours | 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. |
| Need for rescue analgesia (tramadol) | Postoperative 24-hour period | The secondary aim is to compare rescue analgesia amount used in the postoperative 24 h period. |
| Adverse events | Postoperative 24-hour period | The secondary aim is to compare the adverse events (nausea, vomiting, itching, ect) related to opioid use |
Countries
Turkey (Türkiye)
Contacts
Primary Contactayşe ince, assist pof
Outcome results
None listed