Ultrasound- Guided Mid Point Transverse Process to Pleura Block

Ultrasound- Guided Mid Point Transverse Process to Pleura Block: Does It Decreases the Incidence of Acute and Chronic Post Nephrectomy Pain? Randomized Controlled Study.

Radical nephrectomy is the surgical process for the resection of malignant tumors of the kidney necessitating a subcostal flank incision.Mild to severe pain is observed in the postoperative period Ineffective pain management leads to several complications. The mid point transverse process to pleura block (MTP) , this technique was used for pain relief after mastectomy, thoracic, abdominal, and spinal surgery and was found effective due to its simplicity and lower risks compared to epidural analgesia.

Study Overview

• Status: Active, not recruiting
• Conditions: Regional Anesthesia for Postnephrectomy Pain
• Intervention / Treatment: Procedure: Mid transverse process to pleura block (MTP); Procedure: Mid transverse process to pleura Sham block

Detailed Description

Ineffective pain management leads to several complications including immobilization, thromboembolism, persisting chronic pain, increased opioid consumption, and delayed hospital discharge.[3]

Multimodal analgesic (MMA) regimens using several drugs and techniques are considered to be necessary for postoperative pain relief. Regional anesthesia techniques, mainly epidural analgesia and more recently, paravertebral blocks became crucial parts of a MMA regimen after the introduction of ultrasound (US) in the regional anesthesia practice.

The mid point transverse process to pleura block (MTP) block was first described as a modified paravertebral block in 2017. The local anesthetic drugs are administered between the transverse process and the pleura. This results in a local anesthetic drugs spread to the dorsal and ventral rami in the paravertebral space through the fenestrations in the superior costotranverse ligament (SCTL) at the level of injection, and frequently to adjacent levels.

This technique was used for pain relief after mastectomy, thoracic, abdominal, and spinal surgery and was found effective due to its simplicity and lower risks compared to epidural analgesia.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• Inclusion Criteria: - ASA II and III patients
• scheduled for partial or radical nephrectomy
• standard flank incision either subcostal ,intercostal or supracostal approach
• under general anesthesia.

Exclusion Criteria:

• Bleeding disorders,
• Mental or cognitive dysfunction,
• History of chronic analgesic or drug abuse,
• Allergy to local anesthetics
• Local infection at site of block

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; (Mid transverse process to pleura block ) : Patients will receive midpoint transverse process to pleura block with bupivacaine 0.5% (DBK Pharmceutical) (20ml) and dexamethazone 4 mg (SIGMATEC) (1ml) total volume 21 ml	Procedure: Mid transverse process to pleura block (MTP); After marking the level of the incision by surgeon (commonly T11 -T12) The patient will be situated in modified lateral position with flank region over kidney elevated to wide the space between iliac crest and subcostal margin, the block area will be sterilized with povidine-iodine, and high -frequency linear ultrasound probe will be placed oblique parasagittally lateral to the spinous process of T11 or T 12 and scanning till appearance of transverse process, 100-mm short bevel echogenic needle (Vygon) will be inserted in plane from cranial to caudal direction. The desired end point of the needle tip will be the midpoint of the line between the posterior border of transverse process and the pleura.After negative aspiration to avoid intravascular injection levobupivacaine 0.5% and dexamethazone 4mg total volume 21ml will be injected
Sham Comparator: Group II; Patients will receive midpoint transverse process to pleura block with 2ml normal saline subcutaneously (shamblock)	Procedure: Mid transverse process to pleura Sham block; After marking the level of the incision by surgeon (commonly T11 -T12) The patient will be situated in modified lateral position with flank region over kidney elevated to wide the space between iliac crest and subcostal margin, the block area will be sterilized with povidine-iodine, and high -frequency linear ultrasound probe will be placed oblique parasagittally lateral to the spinous process of T11 or T 12 and scanning till appearance of transverse process, 100-mm short bevel echogenic needle (Vygon) will be inserted in plane from cranial to caudal direction. The desired end point of the needle tip will be the midpoint of the line between the posterior border of transverse process and the pleura. with 2ml normal saline subcutaneously will be injected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of acute post nephrectomy pain	by Numerical rating score for pain assessment(NRS) minimum value is 0 maximum value is 10 and higher score means poor outcome	the first postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chronic post nephrectomy pain development.	Numerical rating score for pain assessment (NRS) minimum value is 0 maximum value is 10 and higher score means poor outcome	the first postoperative 3 monthes

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Aliaa Belal, lecturer, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2022
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: nephrectomy pain
• Other Study ID Numbers: POST NEPHRECTOMY PAIN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No