Regional Anesthesia for Postnephrectomy PainNCT05806229
Ultrasound- Guided Mid Point Transverse Process to Pleura Block
A study testing Mid transverse process to pleura block (MTP) in people with Regional Anesthesia for Postnephrectomy Pain, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Regional Anesthesia for Postnephrectomy Pain
- What is being tested?
- Mid transverse process to pleura block (MTP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for partial or radical nephrectomy
- standard flank incision either subcostal ,intercostal or supracostal approach
- under general anesthesia.
Who cannot join
- Bleeding disorders,
- Mental or cognitive dysfunction,
- History of chronic analgesic or drug abuse,
- Allergy to local anesthetics
- Local infection at site of block
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the 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.
- Being tested
- Mid transverse process to pleura block (MTP), Mid transverse process to pleura Sham block
- Keywords
- nephrectomy pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mid transverse process to pleura block (MTP)Procedure or surgery
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 blockProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | (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 Receives: Procedure: Mid transverse process to pleura block (MTP) |
| Group II | Sham comparator | Patients will receive midpoint transverse process to pleura block with 2ml normal saline subcutaneously (shamblock) Receives: Procedure: Mid transverse process to pleura Sham block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: the first postoperative day
Secondary outcomes (1)
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
Measured: the first postoperative 3 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start30 Jul 2022
- Primary completion30 Jan 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia for Postnephrectomy PainStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Muhammad Belal, Tanta University
- Investigators
- Aliaa Belal, lecturer, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806229
- Sponsor's protocol ID
- POST NEPHRECTOMY PAIN
- Status last verified
- Aug 2024
- First submitted
- 15 Mar 2023
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05806229
- Acronym / sponsor ID
- POST NEPHRECTOMY PAIN
- Keywords
- nephrectomy pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: 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 |
| Group II | Sham comparator | Procedure: Mid transverse process to pleura Sham blockPatients will receive midpoint transverse process to pleura block with 2ml normal saline subcutaneously (shamblock) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- scheduled for partial or radical nephrectomy
- standard flank incision either subcostal ,intercostal or supracostal approach
- under general anesthesia.
Key exclusion criteria (5 listed)
- Bleeding disorders,
- Mental or cognitive dysfunction,
- History of chronic analgesic or drug abuse,
- Allergy to local anesthetics
- Local infection at site of block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Group I |
| Mid transverse process to pleura Sham blockAfter 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 | Procedure or surgery | Group II |
Primary outcome
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
1 secondary outcome
chronic post nephrectomy pain development.
Time frame: the first postoperative 3 monthes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliaa Belal, lecturer principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mid transverse process to pleura block (MTP) in people with Regional Anesthesia for Postnephrectomy Pain, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of acute post nephrectomy pain (time frame: the first postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.