M-Tapa Block for Laparoscopic Cholesistectomy

NCT05179629 | Completed

• 1 other identifier: Medipol Hospital 23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall, and may be an opioid-sparing strategy with satisfactory quality improvement in patients undergoing laparoscopic surgery.

Conditions

Cholecystitis; Cholecystitis, Acute; Cholecystitis, Chronic

Keywords

Laparoscopic Cholesistectomy; M-Tapa Block; Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt)

  Change from Baseline Pain Scores at Postoperative 24 hours.

  Postoperative 24 hours period

Secondary Outcomes (1)

• The need for rescue analgesia

  Postoperative 24 hours period

Study Arms (2)

Group M = M-TAPA group

ACTIVE COMPARATOR

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. 100 mg tramadol will be performed for rescue analgesia.

Drug: M TAPA block

Group C = Control group

NO INTERVENTION

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. Wound local anesthetic infiltration will be applied to the patients in the control group. 100 mg tramadol will be performed for rescue analgesia.

Interventions

M TAPA block DRUG

Under aseptic conditions, a high frequency linear probe will be placed on the costochondral angle in the sagittal plane. Then the probe will be slightly angled deeply to visualize the lower view of the perichondrium. We will perform M-TAPA with totally 30 ml (15 ml for each side) of %0,25 bupivacaine.

Group M = M-TAPA group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) classification I-II
• Scheduled for laparoscopic cholesistectomy surgery under general anesthesia

You may not qualify if:

• Bleeding diathesis
• Receiving anticoagulant treatment
• Known local anesthetics and opioid allergy
• Infection of the skin at the site of the needle puncture
• Pregnancy or lactation
• Patients who do not accept the procedure

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (3)

• Tulgar S, Senturk O, Selvi O, Balaban O, Ahiskalioglu A, Thomas DT, Ozer Z. Perichondral approach for blockage of thoracoabdominal nerves: Anatomical basis and clinical experience in three cases. J Clin Anesth. 2019 May;54:8-10. doi: 10.1016/j.jclinane.2018.10.015. Epub 2018 Oct 31. No abstract available.

  PMID: 30388604 BACKGROUND

• Altiparmak B, Toker MK, Uysal AI, Turan M, Demirbilek SG. Reply to Tulgar et al.: Perichondral approach for blockage of thoracoabdominal nerves: Anatomical basis and clinical experience in three cases. J Clin Anesth. 2019 May;54:150-151. doi: 10.1016/j.jclinane.2018.12.005. Epub 2018 Dec 12. No abstract available.

  PMID: 30553219 BACKGROUND

• Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available.

  PMID: 30639940 BACKGROUND

MeSH Terms

Conditions

Cholecystitis; Cholecystitis, Acute; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor and participant were blinded to the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for laparoscopic cholesistectomy surgery will be included in the study. Patients will be randomly divided into two groups (Group M = M-TAPA group, Group C = Control group) including 30 patients each, before entering the operating room.

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: January 6, 2022
• Primary Completion: July 20, 2022
• Study Completion: August 1, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)