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Clinical Trials/NCT05108129
NCT05108129
Completed
N/A

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

Karaman Training and Research Hospital1 site in 1 country76 target enrollmentNovember 11, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Laparoscopic Cholecystectomy
Sponsor
Karaman Training and Research Hospital
Enrollment
76
Locations
1
Primary Endpoint
Total daily consumption of rescue analgesic
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 11, 2021
End Date
March 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Karaman Training and Research Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Total daily consumption of rescue analgesic

Time Frame: Postoperative 24 hours

If Numerical Rating Scale (NRS) score of the patient is equal to or over 4, IV 50 mg tramadol will be applied as a rescue analgesic.

Secondary Outcomes

  • Metoclopromide consumption(Postoperative 24 hour)
  • Quality of recovery levels between groups by using QoR-15 questionnaire(Postoperative 24th hour)
  • Adverse events(Postoperative 24 hour)
  • Anesthetized thoracoabdominal areas at 2 hours after surgery(Postoperative 2 hours)
  • Numerical Rating Scale scores(Postoperative 24 hours)
  • Time to first rescue analgesic(Postoperative 24 hours)
  • Sedation score(Postoperative 24 hour)

Study Sites (1)

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