Comparing the Effects of M-TAPA and TAP Block on Postoperative Analgesia in TAH

NCT05901090 | Completed DMC

• 1 other identifier: M-TAPA vs TAP block on TAH
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Aim is to compare the postoperative analgesic efficacy of M-TAPA block and TAP block and their effect on opioid consumption in patients undergoing open total abdominal hysterectomy (TAH) surgery.

Conditions

Postoperative Pain

Keywords

m-tapa; tap block; total abdominal hysterectomy; regional anesthesia; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Comparing the numerical rating scale scores

  Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

  Postoperative 24 hours

Secondary Outcomes (1)

• Comparing total tramadol consumption

  Postoperative 24 hours

Study Arms (3)

M-TAPA block

ACTIVE COMPARATOR

Patients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control.

Other: M-TAPA block

TAP block

ACTIVE COMPARATOR

Patients had bilateral TAP block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control.

Other: TAP block

Control

NO INTERVENTION

Control group patients were not subjected to any block or local infiltration anesthesia. Their postoperative pain was relieved with tramadol (intravenous) administration.

Interventions

M-TAPA block OTHER

Following sterile conditions for bilateral M-TAPA block application, the transducer was inserted on the chondrium in the sagittal plane at the 9-10th rib level. Subsequently, a deep angle was created with the probe for visualization of the underside of the costochondrium. The sonovisible needle tip was placed just below the chondrium and saline (5 ml) was injected for site confirmation. After the confirmation, 20 ml of 0.25% bupivacaine was administered for each group for a total of 40 ml of local anesthetic. Blocks were applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. M-TAPA block with the same standard technique and drug dose was applied to the contralateral side for each group of M-TAPA patients.

Also known as: Modified thoracoabdominal nerve block through perichondrial approach

M-TAPA block

TAP block OTHER

After the necessary sterilization conditions were established, the linear ultrasound probe was sterilely coated and placed in the middle of the iliac crest with the end limit of the ribs. Starting with skin, the layers in descending order, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum were identified. As the tip of the 80 mm sonovisible needle passed through the muscular layers and fascia, a fascial click was felt and the needle was advanced with ultrasound in a controlled manner. After receiving the second click sensation (passage of the fascia of the internal oblique muscle), the location of the needle was fixed and frequently aspirated and applied to the plane so that 20 ml of 0.25% bupivacaine was applied to each side. (40 ml in total)

Also known as: Transversus abdominis plane block

TAP block

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients older than 35 years of age who underwent open total abdominal hysterectomy under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

You may not qualify if:

• Patients who did not give consent,
• patients with coagulopathy,
• patients with signs of infection at the block application site,
• patients using anticoagulants,
• patients with local anesthetic drug allergies,
• patients undergoing laparoscopic surgery,
• patients with unstable hemodynamics,
• patients who could not cooperate during postoperative pain assessment

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, 58000, 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 Officials

• Oğuz Gündoğdu

  Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 13, 2023
• Study Start: April 12, 2023
• Primary Completion: May 25, 2023
• Study Completion: June 1, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

TU (1)