Modified Thoracoabdominal Nerve Block(M-TAPA) in Total Laparoscopic Hysterectomies

Modified Thoracoabdominal Nerves Block Through Perichondrial Approach (M-TAPA) Versus Incisional Local Anesthetic Administration for Total Laparoscopic Hysterectomy : a Prospective, Randomized Clinical Study

The aim of the study is comparing the postoperative effects of ultrasound-guided Modified Perichondrial Approach to Thoracoabdominal Nerves (M-TAPA) block for postoperative pain control after total laparoscopic hysterectomy.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain,Postoperative
• Intervention / Treatment: Other: M-TAPA Block; Other: Trocar site local anesthetic infiltration

Detailed Description

Pain is one of the most common problems seen in the postoperative period in patients who underwent total laparoscopic hysterectomy.

Multimodal analgesia methods are used in postoperative pain management. Nerve blocks, which are an important component of multimodal analgesia, have an important place in postoperative analgesia management today.

Local Anesthetic Infiltration at the Trocar Site is the most classical nerve block method that has been used for a long time as a part of multimodal analgesia in laparoscopic surgeries.

Modified TAPA block applied with ultrasound guidance; It is a regional block affecting both the anterior and lateral branches of the thoracoabdominal nerves with a perichondrial approach. It is used in total laparoscopic hysterectomies.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ages 18-65
• Elective cases
• ASA I-III functional status
• Body mass index (BMI)<35
• Total laparoscopic hysterectomy planned with general anesthesia
• No contraindications for M-TAPA block to be applied
• Cases that give written and verbal consent for participation in the study will be included.

Exclusion Criteria:

• Conversion to open surgery
• Development of perioperative complications (due to surgery and/or anesthesia)
• Coagulation disorder
• Infection at the injection site
• Allergy to local anesthesia
• Those who used any painkillers in the preoperative 24 hours
• Those who did not agree to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: M-TAPA Group; At the end of the surgery, without waking the patient, a linear transducer will be placed on the costochondral angle in the sagittal plane under ultrasound guidance, and a total of 40 mL of LA (0.25% Bupivacaine) will be applied bilaterally to the lower surface of the chondrium, giving a deep angle to see the lower side of the chondrium centrally.	Other: M-TAPA Block; M-TAPA block will administer ultrasound guided (Sonosite, Inc., Bothell, WA, USA) bilaterally by same anesthesiologist (E.E.) who had more than 10 years experience of regional anesthesia, before weaking from general anesthesia after the surgical procedure. A high-frequency (6-13 MHz) linear probe (HFL38) will be used to identify the transversus abdominis, internal oblique, and external oblique muscles on the costochondral angle in the sagittal plane at the 10th costal margin. In the midclavicular line, between the upper fascia of the transversus abdominis muscle and the lower fascia of the costochondral tissue, at the level of the 10th rib, 20 mL of 0.25 percent bupivacaine will be injected (arcus costarum). The same procedure will be followed on the other side.
Placebo Comparator: Trochar-site Group; At the end of surgery, infiltration analgesia will be applied by the surgeon to all trocar entry sites (4 port entries) with 10 ml of 0.25% bupivacaine (40 mL in total) without waking the patient.	Other: Trocar site local anesthetic infiltration; At the end of surgery, infiltration analgesia will be applied to all trocar entry sites (4 port entries) by the surgeon with 10 ml of 0.25% bupivacaine (40 mL in total) without waking the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative total tramadol consumption for first 24 hours	The intravenous PCA pump will be programmed to deliver a bolus of 20 mg tramadol with a lockout interval of 30 min and no baseline infusion (tramadol 500 mg in 100 mL SF	Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain scores	Pain will be assessed with visual analog score (VAS) in 2 different ways, at rest and with movement (VAS: 0, no pain; 10, worst pain imaginable). VAS scores will be recorded at postoperative 0 (PACU), 1, 2, 4, 8, 12 and 24 hours	at postoperative 0 (PACU), 1, 2, 4, 8, 12 and 24 hours

Collaborators and Investigators

• Sponsor: Gulhane Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 14, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 14, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: M-TAPA, post-operative pain,; Total laparoscopyc histerectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 2023-KAEK-159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No