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Clinical Trials/NCT06601413
NCT06601413
Enrolling by Invitation
N/A

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

Gulhane Training and Research Hospital1 site in 1 country66 target enrollmentOctober 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain,Postoperative
Sponsor
Gulhane Training and Research Hospital
Enrollment
66
Locations
1
Primary Endpoint
Postoperative total tramadol consumption for first 24 hours
Status
Enrolling by Invitation
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
February 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Gulhane Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

ELA ERTEN

medical doctor

Gulhane Training and Research Hospital

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

Outcomes

Primary Outcomes

Postoperative total tramadol consumption for first 24 hours

Time Frame: 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 Outcomes

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

Study Sites (1)

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