M-Tapa Block for Laparoscopic Cholesistectomy

NCT ID: NCT05179629

Last Updated: 2022-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-06
• Study Completion Date: 2022-08-01

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.

Detailed Description

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.

M-TAPA block provides analgesia at the level of T5-T11 in the abdominal region. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen. Analgesia occurs in several dermatomes thanks to the cephalocaudal spread of the local anesthetic solution. There are studies in the literature investigating the effectiveness of M-TAPA block for post-operative pain management in bariatric surgery.

In this study, the investigators aimed to evaluate the effectiveness of M-TAPA block for postoperative analgesia management after laparoscopic cholecystectomy surgery.Primary aim is to compare the postoperative pain scores (VAS), and secondary aim is to compare the postoperative rescue analgesic use and postoperative opioid consumption, and the side effects (allergic reaction, nausea, vomiting) associated with opioid use.

Conditions

Cholecystitis; Cholecystitis, Acute; Cholecystitis, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group M = M-TAPA group

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.

Group Type: ACTIVE_COMPARATOR

M TAPA block

Intervention Type: 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 C = Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

M TAPA block

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Bahadir Ciftci

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Medipol University Hospital

Istanbul, Bagcilar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 30388604 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30553219 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30639940 (View on PubMed)

Other Identifiers

Medipol Hospital 23

Identifier Type: -

Identifier Source: org_study_id