Clinical trial NCT05207306: Comparision of M-TAPA Versus TAPB After Laparoscopic Cholecystectomy
Official title: Postoperative Analgesic Effect of Ultrasound-guided Thoracoabdominal Nerves Block Through Perichondrial Approach in Patients Undergoing Laparoscopic Cholecyctectomy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain, Acute
Keywords: cholecystectomy
thoracoabdominal nerves block
transversus abdominis plane block
interfascial plane block
regional analgesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This randomized controlled study is designed to evaluate the postoperative analgesic effect of the ultrasound-guided modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. The investigators hypothesized that the US-guided M-TAPA would be more effective in postoperative pain control than the US-guided subcostal transversus abdominis plane block (TAPB).

Detailed description: Patients (Age\>18 years) undergoing elective laparoscopic cholecystectomy are randomly allocated to receive bilateral US-guided M-TAPA (n=30) or bilateral subcostal TAPB (n=30) using 0.375% ropivacaine 15ml (total 30ml) before surgical incision. The blinded investigator evaluates each patient's parameters (Numeric rating scale, nausea, vomiting, pruritis, and patient satisfaction) at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge. The primary outcome is pain severity evaluated by a NRS at 12hours postoperatively.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo elective laparoscopic cholecystectomy
* American Society of Anesthesiologists (ASA) physical classification I-II

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical classification III or more
* Chronic pain, chronic analgesic or antidepressant or anticonvulsant use
* Allergies to anesthetic or analgesic medications used in the protocol
* Single port laparoscopic cholecystectomy
* Patients with infection at the abdominal wall
* Medical or psychological disease that can affect the treatment response
* Do not understand our study

Primary outcomes:
measure: Maximum postoperative pain score during 12hours postoperatively
timeFrame: at 12hour postoperatively.
Secondary outcomes:
measure: Postoperative pain score at rest
timeFrame: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge
measure: Postoperative pain score during coughing
timeFrame: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge
measure: Patient satisfaction before discharge
timeFrame: at immediately before discharge
measure: Occurrence rate of postoperative nausea, vomiting
timeFrame: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Please Select An Option
Study officials:
affiliation: Seoul National University Hospital
name: Hojin Lee, MD
role: STUDY_CHAIR
References:
citation: Aikawa K, Tanaka N, Morimoto Y. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides a sufficient postoperative analgesia for laparoscopic sleeve gastrectomy. J Clin Anesth. 2020 Feb;59:44-45. doi: 10.1016/j.jclinane.2019.06.020. Epub 2019 Jun 15. No abstract available.
citation: Ueshima H, Hiroshi O. RETRACTED: Thoracoabdominal nerves block through the perichondral approach for effective perioperative analgesia during upper abdominal surgery. J Clin Anesth. 2020 Feb;59:7. doi: 10.1016/j.jclinane.2019.06.008. Epub 2019 Jun 5. No abstract available.
citation: Taylor R Jr, Pergolizzi JV, Sinclair A, Raffa RB, Aldington D, Plavin S, Apfel CC. Transversus abdominis block: clinical uses, side effects, and future perspectives. Pain Pract. 2013 Apr;13(4):332-44. doi: 10.1111/j.1533-2500.2012.00595.x. Epub 2013 Feb 13.
citation: Oksar M, Koyuncu O, Turhanoglu S, Temiz M, Oran MC. Transversus abdominis plane block as a component of multimodal analgesia for laparoscopic cholecystectomy. J Clin Anesth. 2016 Nov;34:72-8. doi: 10.1016/j.jclinane.2016.03.033. Epub 2016 May 2.
citation: Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3.