Clinical trial NCT05108129: USG-guided M-TAPA vs OSTAP Block in Patients Undergoing Laparoscopic Cholecystectomy
Official title: Ultrasound-guided Modified Thoracoabdominal Nerves Block Through Perichondrial Approach(M-TAPA)Versus Oblique Subcostal Transversus Abdominis Plane Block(OSTAP) for Postoperative Analgesia of Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Keywords: modified-thoracoabdominal nerves block
oblique subcostal transversus abdominis plane block
postoperative pain
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Allocation: Randomized Intervention Model: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: In this study, the postoperative analgesic effect of ultrasound-guided modified thoracoabdominal nerves blocks through perichondrial approach (M-TAPA) and oblique subcostal transversus abdominis plane block(OSTAP) will be searched in patients recruiting for laparoscopic cholecystectomy (LC) and the two groups will be compared in terms postoperative opioid consumption.

The primary aim of this study is to compare the effects of ultrasound-guided (M-TAPA) and OSTAP blocks on opioid consumption after LC surgery. It is hypothesized that M-TAPA will reduce opioid consumption of the patients more than the OSTAP block.

Detailed description: Laparoscopy is a minimally invasive procedure, but postoperative pain is still the most common symptom after laparoscopic cholecystectomy (LC).

Oblique subcostal transversus abdominis plane (OSTAP) block is a regional anesthesia technique defined for abdominal surgeries. Previously, several studies have reported that ultrasound-guided OSTAP blocks reduce postoperative pain scores after LC. M-TAPA block is performed by applying local anesthetic to the lower surface of the chondrium. This technique provides effective analgesia in the abdominal wall.

This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After randomization, M-TAPA and OSTAP blocks will be performed under ultrasound guidance after administering general anesthesia and prior to the skin incision. An anesthesiologist who performed blocks will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative pain scores, vital parameters, nausea and vomiting, antiemetic, opioid consumption, and Quality of Recovery score will be blinded to group assignment.

Eligibility criteria: Inclusion Criteria:

* Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study

Exclusion Criteria:

* presence of coagulation disorder
* infection at the injection site of the block
* known allergy to local anesthetics
* advanced hepatic or renal failure
* can not communicate in Turkish
* history of abdominal surgery or trauma
* conversion of laparoscopic to open surgery
* consumption of any pain killers within the 24 h before the operation
* chronic opioid consumption
* pregnancy
* alcohol or drug abuse
* body mass index (BMI) ≥ 35 kg m-2.

Primary outcomes:
measure: Total daily consumption of rescue analgesic
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Numerical Rating Scale scores
timeFrame: Postoperative 24 hours
measure: Time to first rescue analgesic
timeFrame: Postoperative 24 hours
measure: Adverse events
timeFrame: Postoperative 24 hour
measure: Metoclopromide consumption
timeFrame: Postoperative 24 hour
measure: Sedation score
timeFrame: Postoperative 24 hour
measure: Quality of recovery levels between groups by using QoR-15 questionnaire
timeFrame: Postoperative 24th hour
measure: Anesthetized thoracoabdominal areas at 2 hours after surgery
timeFrame: Postoperative 2 hours
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Betul Basaran, MD,DESA
role: STUDY_DIRECTOR
References: