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

NCT ID: NCT06601413

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-02-01

Brief Summary

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.

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.

Conditions

Pain,Postoperative

Study Design

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

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

M-TAPA Block

Intervention Type: OTHER

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.

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.

Group Type: PLACEBO_COMPARATOR

Trocar site local anesthetic infiltration

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

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

Sponsors

Gulhane Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

ELA ERTEN

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Health Sciences University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023-KAEK-159

Identifier Type: -

Identifier Source: org_study_id