Ultrasound- Guided Mid Point Transverse Process to Pleura Block

Not Applicable

Completed

• Conditions: Regional Anesthesia for Postnephrectomy Pain
• Interventions: Procedure: Mid transverse process to pleura Sham block; Procedure: Mid transverse process to pleura block (MTP)

• Registration Number: NCT05806229
• Lead Sponsor: Tanta University

Brief Summary

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.

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 Timeline

• Study Start: 2022-07-30
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-10
• Primary Completion: 2024-01-30
• Study Completion: 2024-03-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	Mid transverse process to pleura Sham block	Patients will receive midpoint transverse process to pleura block with 2ml normal saline subcutaneously (shamblock)
Group I	Mid transverse process to pleura block (MTP)	(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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tanta university; 🇪🇬 Tanta, Egypt