Completed

NCT Number: NCT05806229

Ultrasound- Guided Mid Point Transverse Process to Pleura Block

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.

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Key information

Conditions

Regional Anesthesia for Postnephrectomy Pain

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta university

Tanta, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mid transverse process to pleura block (MTP)

Procedure

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

Mid transverse process to pleura Sham block

Procedure

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

Primary outcomes

Assessment of acute post nephrectomy pain

Time frame: 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 outcomes

chronic post nephrectomy pain development.

Time frame: 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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Apr 10, 2023
Registry last updated: Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.