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Postoperative Analgesia in Patients Undergoing Open Renal SurgeryNCT07881523

Ultrasound-Guided Midpoint Transverse Process to Pleura Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Open Renal Surgery :A Randomized Comparative Study.

A study testing Midpoint Transverse Process to Pleura (MTP)Block and Erector spinae plane (ESP) block in people with Postoperative Analgesia in Patients Undergoing Open Renal Surgery, run by Minia University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this randomized comparative clinical trial is to compare the analgesic effectiveness of ultrasound-guided Midpoint Transverse Process to Pleura (MTP) block versus Erector Spinae Plane (ESP) block in adult patients undergoing open renal surgery. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Midpoint Transverse Process to Pleura (MTP)Block and Erector spinae plane (ESP) block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Nov 2026to 1 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA physical status I-II
  • BMI 20-35
  • age between 18-65 years
  • will have open renal surgery (open stone kidney or nephrectomy )

Who cannot join

  • Patient refusal
  • Any allergy or contraindications to any of the study drugs.
  • Pain or chronic analgesic administration in the preoperative period.
  • Patients with coagulopathy or emergency surgery
  • Infection at local needle site of insertion.
  • Sever cardiac ,respiratory or liver diseases

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Engy Nady Mikhail, MBBS contact

+201281701312

engy.nadii@gmail.com

Sarah Omar Mousa, MD contact

+201005376176

sara.mohamed@mu.edu.eg

Egypt1 site
  • Nephrology and Urology Minia University Hospital

    Minya, Minya Governorate, 61111

    Sarah O Mousa, MD, +201005376176, sara.mohamed@mu.edu.eg

Other trials in Egypt

About this study

The goal of this randomized comparative clinical trial is to compare the analgesic effectiveness of ultrasound-guided Midpoint Transverse Process to Pleura (MTP) block versus Erector Spinae Plane (ESP) block in adult patients undergoing open renal surgery. The main question it aims to answer is:

Does MTP block provide postoperative analgesia comparable to ESP block, as assessed by postoperative opioid consumption and pain scores?

Read more

Researchers will compare MTP block with ESP block to evaluate postoperative opioid consumption, pain intensity, time to first rescue analgesia, and the incidence of adverse events.

Participants will receive general anesthesia followed by either ultrasound-guided MTP block or ESP block before surgery. Postoperative pain and opioid consumption will be assessed for 24 hours after surgery.

Read the detailed description

This prospective, randomized, comparative,clinical study will be conducted to compare the analgesic efficacy of ultrasound-guided midpoint transverse process to pleura (MTP) block and erector spinae plane (ESP) block in patients undergoing elective open renal surgery under general anesthesia.

A total of 50 patients of either sex, aged 18-65 years, with American Society of Anesthesiologists (ASA) physical status I-II and body mass index (BMI) of 20-35 kg/m², scheduled for elective open renal surgery through a subcostal incision, will be enrolled. The study will be conducted at Minia University after approval by the Institutional Ethical Committee and obtaining written informed consent from all participants.

Eligible patients will be randomly allocated in a 1:1 ratio into two equal groups, with 25 patients in each group, using a computer-generated randomization sequence with concealed allocation. Group I will be assigned to receive an ultrasound-guided MTP block, while Group II will be assigned to receive an ultrasound-guided ESP block.

Standardized general anesthesia will be administered to all patients. Anesthesia will be induced with intravenous propofol (2-2.5 mg/kg), fentanyl (1-2 µg/kg), and atracurium (0.5 mg/kg). Anesthesia will be maintained with 1-1.5 MAC isoflurane in an oxygen/air mixture, with additional doses of atracurium administered as required. Ventilation will be adjusted to maintain an end-tidal carbon dioxide level of 30-35 mmHg.

Additional intraoperative fentanyl (1 µg/kg) will be administered incrementally according to predefined hemodynamic criteria, specifically an increase in heart rate or mean arterial blood pressure of more than 20% from baseline.

The assigned regional block will be performed after induction of general anesthesia and before surgical incision, with the patient positioned in the lateral decubitus position and the operative side uppermost. All blocks will be performed under ultrasound guidance at the T9 vertebral level using 30 mL of 0.25% bupivacaine.

For the MTP group, a high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation approximately 2-3 cm lateral to the midline at the T9 level. The transverse process and pleura will be identified. Using an in-plane technique, a 22-gauge echogenic needle will be advanced in a cranial-to-caudal direction until the needle tip is positioned midway between the posterior aspect of the transverse process and the pleura. Following negative aspiration and confirmation of appropriate needle placement by hydrodissection, 30 mL of 0.25% bupivacaine will be injected incrementally under continuous ultrasound visualization.

For the ESP group, the T9 transverse process will be identified using a high-frequency linear ultrasound probe placed approximately 2-3 cm lateral to the midline in a longitudinal parasagittal orientation. The trapezius, rhomboid major, and erector spinae muscles will be identified. Using an in-plane technique, a 22-gauge echogenic needle will be advanced in a cranial-to-caudal direction until the needle tip reaches the interfascial plane deep to the erector spinae muscle and superficial to the transverse process. Following negative aspiration and hydrodissection, 30 mL of 0.25% bupivacaine will be injected incrementally under continuous ultrasound visualization.

At the end of surgery, residual neuromuscular blockade will be reversed with atropine (0.02 mg/kg) and neostigmine (0.04 mg/kg), followed by tracheal extubation. Patients will subsequently be transferred to the post-anesthesia care unit and then to the ward after achievement of a modified Aldrete score of at least 9.

A standardized multimodal analgesic regimen will be administered to all patients. Intravenous paracetamol 1 g will be administered at the end of surgery and subsequently every 6 hours. Intravenous ketorolac 30 mg will be administered every 8 hours during the first postoperative day. Intravenous nalbuphine will be administered as rescue analgesia when the postoperative NRS pain score is ≥4.

The primary outcome will be total postoperative opioid consumption, expressed as intravenous nalbuphine consumption in milligrams during the first 24 postoperative hours.

Secondary outcomes will include intraoperative fentanyl consumption, time to first rescue analgesic request, postoperative pain scores at rest and during movement, hemodynamic parameters, patient satisfaction with pain relief, duration of hospital stay, and the incidence of perioperative complications.

Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Hemodynamic parameters, including heart rate, oxygen saturation, systolic blood pressure, diastolic blood pressure, and mean arterial pressure, will be recorded at predefined intraoperative and postoperative time points.

Patient satisfaction with postoperative pain management will be assessed using a 5-point Likert scale.

Perioperative complications will be recorded, including postoperative nausea and vomiting, hypotension, bradycardia, tachycardia, respiratory depression, vascular puncture, pneumothorax, allergic reactions, and signs of local anesthetic systemic toxicity.

If an NRS score of ≥4 is recorded during the first postoperative hour, block failure will be considered according to the study protocol. Rescue nalbuphine will be administered, and the patient will be excluded from the study.

The study will be conducted over a period of one year. The collected data will be analyzed statistically to compare the postoperative analgesic outcomes between the MTP and ESP block groups.

Being tested
Midpoint Transverse Process to Pleura (MTP)Block, Erector spinae plane (ESP) block
Keywords
Postoperative Analgesia, Open Renal Surgery, MTP, ESP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Midpoint Transverse Process to Pleura (MTP)BlockProcedure or surgery

    After induction of general anesthesia, the patient will be positioned laterally. Under aseptic precautions, a high-frequency linear ultrasound probe will be placed parasagittally at T9, 2-3 cm lateral to the midline. The transverse process and pleura will be identified. Using an in-plane cranial-to-caudal approach, a 22-G echogenic needle will be advanced to the midpoint between the transverse process and pleura. After negative aspiration and hydrodissection with 1-2 mL saline, 30 mL of 0.25% bupivacaine will be injected incrementally under continuous ultrasound visualization.

  • Erector spinae plane (ESP) blockProcedure or surgery

    After induction of general anesthesia, the patient will be positioned laterally with the operative side uppermost. Under aseptic precautions, a high-frequency linear ultrasound probe will be placed parasagittally at T9, 2-3 cm lateral to the midline to identify the transverse process and overlying muscles. Using an in-plane cranial-to-caudal approach, a 22-G echogenic needle will be advanced deep to the erector spinae muscle and superficial to the transverse process. After negative aspiration and hydrodissection with 1-2 mL saline, 30 mL of 0.25% bupivacaine will be injected incrementally under continuous ultrasound visualization, confirming appropriate fascial spread.

Study groups in NCT07881523
Study groupRoleWhat they receive
midpoint transverse process to pleura (MTP) blockActive comparatorAfter induction of general anesthesia, the patient will be positioned laterally. Under aseptic precautions, a high-frequency linear ultrasound probe will be placed parasagittally at T9, 2-3 cm lateral to the midline. The transverse process and pleura will be identified. Using an in-plane cranial-to-caudal approach, a 22-G echogenic needle will be advanced to the midpoint between the transverse process and pleura. After negative aspiration and hydrodissection with 1-2 mL saline, 30 mL of 0.25% bupivacaine will be injected incrementally under continuous ultrasound visualization.
Receives: Procedure: Midpoint Transverse Process to Pleura (MTP)Block
Erector spinae plane (ESP) blockActive comparatorAfter induction of general anesthesia, the patient will be positioned laterally with the operative side uppermost. Under aseptic precautions, a high-frequency linear ultrasound probe will be placed parasagittally at T9, 2-3 cm lateral to the midline to identify the transverse process and overlying muscles. Using an in-plane cranial-to-caudal approach, a 22-G echogenic needle will be advanced deep to the erector spinae muscle and superficial to the transverse process. After negative aspiration and hydrodissection with 1-2 mL saline, 30 mL of 0.25% bupivacaine will be injected incrementally under continuous ultrasound visualization, confirming appropriate fascial spread.
Receives: Procedure: Erector spinae plane (ESP) block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome is the total postoperative opioid consumption, expressed as I.V. Nalbuphine in mg in the first 24 hour postoperatively.

    measure I.V. Nalbuphine in mg in the first 24 hour postoperatively

    Measured: the first 24 hour postoperatively

Secondary outcomes (2)
  1. Time to first analgesic request

    First Analgesic Request: time from end of surgery to first request of rescue analgesia accessed by minutes, if pain persists (NRS ≥ 4) nalbuphine 3mg IV will be given as a rescue analgesia.

    Measured: time from end of surgery to first request of rescue analgesia accessed by minutes (assessed during the first 24 hours postoperatively.

  2. Postoperative pain assessment

    using the Numeric Rating Scale (NRS) at rest and during movement .Pain intensity will be assessed by asking patients to rate their current pain by selecting a number from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. The scale was explained to all patients prior to assessment to ensure understanding.

    No pain: 0 Mild pain: 1-2 Moderate pain: 4-6 Severe pain: 7-10

    Measured: immediately after surgery, after 2hr, 4hr,6hr,8hr,12hr,16hr,20hr,24hr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

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
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07881523
Sponsor's protocol ID
2040:7/2026
Status last verified
Sep 2026
First submitted
12 Oct 2026
Last updated
19 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Midpoint Transverse Process to Pleura (MTP)Block and Erector spinae plane (ESP) block in people with Postoperative Analgesia in Patients Undergoing Open Renal Surgery, run by Minia 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 19 Oct 2026. 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Engy Nady Mikhail, MBBS (+201281701312, engy.nadii@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome is the total postoperative opioid consumption, expressed as I.V. Nalbuphine in mg in the first 24 hour postoperatively. (time frame: the first 24 hour postoperatively). 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 19 Oct 2026.

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