Modified Thoracoabdominal Nerves Block Through Perichondrial Approach: a New Strategy With a Wide Range of Utilization in Laparoscopic Gynecological Surgeries.

NCT06039423 | Completed Phase 2

• 1 other identifier: 0306061
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The current study was to assess the analgesic effects of the modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) block in patients undergoing gynecological laparoscopic surgeries.The primary goal was to evaluate the analgesic efficacy of M-TAPA block accomplished prior to surgery in patients undergoing Laparoscopic gynecological surgeries

Conditions

Analgesic Efficacy of M-TAPA Block Accomplished Prior to Surgery in Patients Undergoing Laparoscopic Gynecological Surgeries

Outcome Measures

Primary Outcomes (1)

• Total dose of fentanyl consumption

  analgesic efficacy of M-TAPA block

  after 1 hour postoperative

Secondary Outcomes (1)

• postoperative morphine given (mg) in the first 24 hrs

  after 24 hours postoperatively

Study Arms (2)

Group (M)

ACTIVE COMPARATOR

The M-TAPA block will be combined with general anaesthesia. :

Procedure: The M-TAPA block

Group (C)

PLACEBO COMPARATOR

(control group) conventional general anaesthesia receiving multimodal analgesia.

Drug: Ketorolac

Interventions

The M-TAPA block PROCEDURE

A high frequency (6-12 MHz) US linear probe was placed in the sagittal plane on the 10 th costal margin in the midline. The probe was then angulated deeply to visualize the lower surface of the costal cartilage. Via in plane technique, a 21 gauge Tuohy needle was inserted cranially between the lower fascia of the costal cartilage and upper fascia of the transversus abdominis muscle by moving the needle tip towards the posterior aspect of the 10 th costal cartilage and 20 mL bupivacaine (0.25 %) was injected.

Group (M)

Ketorolac DRUG

conventional general anaesthesia receiving multimodal analgesia

Group (C)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult female patients
• aged 20-65 years,
• normal coagulation profile,
• scheduled for ambulatory laparoscopic gynecological surgeries under general anaesthesia.

You may not qualify if:

• patient refusal,
• skin infection at the site of the needle puncture
• known allergies to any of the study medications

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Faculty of Medicin

Alexandria, 21615, Egypt

Location

MeSH Terms

Interventions

Ketorolac

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2023
• First Posted: September 15, 2023
• Study Start: July 2, 2023
• Primary Completion: August 15, 2023
• Study Completion: September 7, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-07

Locations

EG (1)