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Modified Thoracoabdominal Nerve Plane Block In Laparoscopic Sleeve Gastrectomy

M

Medipol Health Group

Status

Enrolling

Conditions

Acute Post Operative Pain
Laparoscopic Sleeve Gastrectomy
Bariatric Surgery
Obesity

Treatments

Procedure: M-TAPA block
Procedure: Postoperative pain management

Study type

Interventional

Funder types

Other

Identifiers

NCT06515691
Medipol Hospital 3

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Group M = M-TAPA Block group
Experimental group
Description:
M-TAPA block will be performed andd standard postoperaive pain management protocols will be applied.
Treatment:
Procedure: Postoperative pain management
Procedure: M-TAPA block
Group K = control group
Active Comparator group
Description:
Standard postoperative pain management protocols will be applied. No plane block will be applied.
Treatment:
Procedure: Postoperative pain management

Trial contacts and locations

1

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Central trial contact

ayşe ince, assist pof

Data sourced from clinicaltrials.gov

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