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

Not Applicable

• Conditions: Pain,Postoperative
• Interventions: Other: M-TAPA Block; Other: Trocar site local anesthetic infiltration

• Registration Number: NCT06601413
• Lead Sponsor: Gulhane Training and Research Hospital

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-14
• Last Update Submitted: 2024-09-14
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-10-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M-TAPA Group	M-TAPA Block	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.
Trochar-site Group	Trocar site local anesthetic infiltration	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.

Primary Outcome Measures

Name	Time	Method
Postoperative total tramadol consumption for first 24 hours	Postoperative 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

Secondary Outcome Measures

Name	Time	Method
Postoperative pain scores	at postoperative 0 (PACU), 1, 2, 4, 8, 12 and 24 hours	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

Trial Locations

Locations (1)

Health Sciences University; 🇹🇷 Ankara, Turkey