Comparison of ESP Block and M-TAPA Block Efficiency in Postoperative Analgesia Management in Nephrectomy Cases

NCT06566859 | Not Yet Recruiting

• 1 other identifier: 2024-297
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Relieving postoperative nephrectomy pain requires multimodal approaches. Peripheral blocks such as ESP block and M-TAPA block and multimodal analgesics reduce side effects by reducing the use of other analgesics. This study aimed to compare the effectiveness of erector spinae plane block (ESP block) and modified thoracoabdominal nerve blocking with perichondrial approach (M-TAPA block) in postoperative analgesia management in nephrectomy cases.

Conditions

Pain, Postoperative

Keywords

nerve block; pain management; postoperative period; postoperative complications; regional anesthesia; pain

Outcome Measures

Primary Outcomes (6)

• Postoperative Pain Management

  The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.

  0.hour

• Postoperative Pain Management

  The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.

  6.hour

• Postoperative Pain Management

  The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.

  12.hour

• Postoperative Pain Management

  The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.

  24.hour

• Postoperative Pain Management

  Total amount of analgesic used in 24 hours

  24 hours

• Postoperative Pain Management

  Time of first additional analgesic requirement up to 24 hours

  24 hours

Study Arms (2)

M-TAPA Block

Patients who have standard anesthesia are randomized with the research randomizer application while under anesthesia and M-TAPA block is applied under ultrasound guidance in the preoperative period. For the block, 50 mg of 0.25% bupivacaine and 100 mg lidocaine are injected, totaling 20cc.

Other: NRS 0. hour; Other: NRS 6. Hour; Other: NRS 12. Hour; Other: NRS 24. Hour

ESP Block

Patients who have standard anesthesia are randomized with the research randomizer application while under anesthesia and ESP block is applied under ultrasound guidance in the preoperative period. For the block, 50 mg of 0.25% bupivacaine and 100 mg lidocaine are injected, totaling 20cc.

Other: NRS 0. hour; Other: NRS 6. Hour; Other: NRS 12. Hour; Other: NRS 24. Hour

Interventions

NRS 0. hour OTHER

Numerical rating scala

ESP Block; M-TAPA Block

NRS 6. Hour OTHER

Numerical rating scala

ESP Block; M-TAPA Block

NRS 12. Hour OTHER

Numerical rating scala

ESP Block; M-TAPA Block

NRS 24. Hour OTHER

Numerical rating scala

ESP Block; M-TAPA Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients aged 18 and over with ASA1-2 who underwent elective nephrectomy. .

You may qualify if:

• All patients aged 18 and over with ASA1-2 who underwent elective nephrectomy

You may not qualify if:

• ASA ≥3
• Body mass index\>35 kg/ m²
• Infection in the block area
• Coagulation disorder,
• Known allergy to local anesthetics
• Pregnant
• Patient with neuropathy
• Patient without cooperation
• Patient who refuses to participate in the study
• Patients under 18 years of age

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

BasaksehirCamSakuraH

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Postoperative Complications; Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Hilal Akça

  BasaksehirCamSakuraH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilal Akça

CONTACT

05548421509; drhllbs@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 22, 2024
• Study Start: September 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

TU (1)