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

NCT06601413 | Enrolling By Invitation

• 1 other identifier: 2023-KAEK-159
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain,Postoperative

Keywords

M-TAPA, post-operative pain,; Total laparoscopyc histerectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative pain scores

  at postoperative 0 (PACU), 1, 2, 4, 8, 12 and 24 hours

Study Arms (2)

M-TAPA Group

ACTIVE COMPARATOR

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

Trochar-site Group

PLACEBO COMPARATOR

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

Interventions

M-TAPA Block 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.

M-TAPA Group

Trocar site local anesthetic infiltration 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.

Trochar-site Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulhane Training and Research Hospital: lead

Study Sites (1)

Health Sciences University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)