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Erector Spinae Plane BlockNCT07560267

Efficacy of Ultrasound-Guided Erector Spinae Block for Postoperative Pain Management in Nephrectomy

A study testing Ultrasound-Guided Erector Spinae Plane (ESP) Block in people with Erector Spinae Plane Block and Nephrectomy, run by Bangladesh Medical University at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial aims to evaluate the effectiveness of the ultrasound-guided erector spinae plane (ESP) block in managing postoperative pain for patients undergoing open nephrectomy (kidney removal surgery). Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
Ultrasound-Guided 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
66 participants
Where
1 siteBangladesh
Study dates
1 Sep 2025to 30 Jul 2026
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 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult patients aged 18 to 64 years
  • Scheduled for open nephrectomy (radical or partial) under general anesthesia
  • ASA physical status I-II (American Society of Anesthesiologists classification)

Who cannot join

  • Allergy to local anesthetics.
  • Local infection or inflammation at the site of the Block placement.
  • Presence of anatomical deformities in the spine
  • Coagulopathy or any bleeding disorder.
  • Pregnancy or breastfeeding women.
  • History of severe chronic pain syndrome

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site
  • Bangladesh Medical University

    Dhaka, 1000

Other trials in Bangladesh

About this study

Official title: Efficacy of Ultrasound-Guided Erector Spinae Plane Block in Postoperative Pain Management in Nephrectomy: A Randomized Controlled Trial

This clinical trial aims to evaluate the effectiveness of the ultrasound-guided erector spinae plane (ESP) block in managing postoperative pain for patients undergoing open nephrectomy (kidney removal surgery). The study will compare this new technique to traditional pain management methods, such as opioid medications, to assess whether the ESP block reduces pain and the need for opioids after surgery.

Patients will be randomly assigned to one of two groups:

Read more

Group C will receive conventional pain relief methods, including opioids. Group E will receive the ultrasound-guided ESP block in addition to general anesthesia.

The main goals are to determine:

How much pain relief each method provides, measured using a visual analog scale (VAS).

The total amount of opioids required during the first 24 hours post-surgery.

Additional measurements will include monitoring vital signs like heart rate, blood pressure, and oxygen levels.

This study will help find safer and more effective ways to manage pain after nephrectomy, reducing the reliance on opioids and improving patient recovery

Read the detailed description

This randomized controlled trial aims to assess the efficacy of ultrasound-guided erector spinae plane (ESP) block in managing postoperative pain in patients undergoing open nephrectomy. Nephrectomy, a common procedure for kidney removal, often results in severe postoperative pain, which can contribute to complications such as postoperative pulmonary complications (PPC) and delayed recovery. Traditional analgesic techniques, including systemic opioids and epidural analgesia, have various side effects such as nausea, vomiting, constipation, and respiratory depression. Additionally, opioids may lead to tolerance, especially in cancer patients. Erector spinae plane block (ESP) is a newer regional technique that has gained attention due to its potential to provide effective analgesia with minimal side effects.

This study will evaluate whether the ESP block can provide better pain control and reduce opioid consumption compared to conventional pain management techniques. The ESP block targets the erector spinae muscle and provides analgesia via fascial plane blocks, which is believed to be effective in controlling visceral and somatic pain, typically associated with nephrectomy.

The trial will involve 66 adult patients scheduled for open nephrectomy under general anesthesia. Patients will be randomly assigned to one of two groups:

Control Group (Group C): Patients will receive conventional analgesia, including opioids and standard local anesthetic techniques.

Intervention Group (Group E): Patients will receive general anesthesia combined with the ultrasound-guided ESP block, administered immediately before anesthesia induction.

The primary outcome of the trial is to measure the first postoperative opioid requirement, utilizing the Visual Analogue Scale (VAS) for pain assessment. Secondary outcomes include the total opioid consumption in the first 24 hours, the intensity of postoperative pain at various time points, and the hemodynamic responses (heart rate, blood pressure). Additionally, peak expiratory flow rate (PEFR) will be monitored to assess respiratory function as part of the recovery process.

By evaluating these outcomes, the study aims to provide insights into whether ESP block can serve as a safer, effective alternative to traditional analgesia, improving postoperative pain management and reducing the risks associated with opioid use. The results may guide clinical practice in nephrectomy pain management, offering a potential improvement in patient recovery times and satisfaction.

Being tested
Ultrasound-Guided Erector Spinae Plane (ESP) Block
Keywords
Erector Spinae Plane Block (ESP), Postoperative Pain Management, Opioid Consumption, Nephrectomy
Medical subject headings
Pain, Postoperative

What participants receive

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

  • Ultrasound-Guided Erector Spinae Plane (ESP) BlockProcedure or surgery

    The Ultrasound-Guided Erector Spinae Plane (ESP) Block is a regional anesthesia technique used to provide postoperative pain relief. In this study, the intervention involves the administration of a local anesthetic (0.25% bupivacaine) into the fascial plane between the erector spinae muscle and the transverse process of the vertebra using ultrasound guidance. The procedure is performed immediately before the induction of general anesthesia in patients undergoing open nephrectomy. The goal of the ESP block is to reduce postoperative pain, minimize opioid consumption, and improve recovery outcomes while maintaining hemodynamic stability. This intervention is compared to conventional pain management methods, which primarily rely on systemic opioids and other standard analgesics.

Study groups in NCT07560267
Study groupRoleWhat they receive
Control Group: Conventional Pain ManagementNo interventionThis group will receive general anesthesia along with conventional pain management techniques, including opioid analgesics and other standard interventions typically used in postoperative nephrectomy care
Intervention Group: Ultrasound-Guided Erector Spinae Plane BlockExperimentalPatients in this group will receive general anesthesia in combination with the ultrasound-guided erector spinae plane (ESP) block, administered before the induction of anesthesia. The block targets the erector spinae muscle fascial plane, aiming to reduce postoperative pain and opioid consumption.
Receives: Procedure: Ultrasound-Guided Erector Spinae Plane (ESP) Block

What is being measured

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

  1. Visual Analogue Scale (VAS) for pain

    VAS score measures the intensity of pain, with 0 indicating no pain and 10 indicating the worst possible pain.

    A lower VAS score means less pain and better pain management. A higher VAS score means more pain and poorer pain control.

    Measured: VAS score will be The VAS score will be recorded within the first 24 hours after surgery upon the patient's arrival in recovery, at 1, 3, 6,12 and 24 hours.

Secondary outcomes (6)
  1. Total Opioid Consumption

    Total opioid consumption will be tracked and recorded for each group during the first 24 hours post-surgery. The total amount of opioids used (in milligrams) will serve as an indicator of pain control effectiveness. A reduction in opioid consumption in the ESP block group, compared to the control group, would suggest that the ESP block is effective in reducing the need for opioids, thereby minimizing opioid-related side effects.

    Measured: Total opioid consumption will be calculated and recorded in mg within the first 24 hours postoperatively.

  2. Peak Expiratory Flow Rate (PEFR)

    PEFR will be measured preoperatively and at multiple points postoperatively (1, 3, 6, and 24 hours) to assess respiratory function. This is particularly important in nephrectomy patients, as effective pain management helps promote better respiratory outcomes and reduce the risk of atelectasis or other complications. A higher PEFR value suggests better lung function and recovery.

    Measured: PEFR values will be assessed preoperatively and at arrival to 1, 3, 6, and 24 hours postoperatively.

  3. Heart Rate (HR) Monitoring

    Heart rate (HR) will be monitored preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours). This will help assess whether the ESP block maintains hemodynamic stability without causing significant fluctuations, such as tachycardia (increased heart rate), compared to conventional analgesia methods.

    Measured: Heart rate (HR) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.

  4. Systolic Blood Pressure (SBP) Monitoring in mmHg

    Systolic blood pressure (SBP) will be recorded preoperatively and at regular intervals (0, 1, 3, 6, 12, and 24 hours) postoperatively. The aim is to evaluate whether the ESP block offers better hemodynamic control by preventing significant blood pressure fluctuations compared to conventional analgesia methods.

    Measured: Systolic blood pressure (SBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.

  5. Diastolic Blood Pressure (DBP) Monitoring in mmHg

    Diastolic blood pressure (DBP) will be measured preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours). Monitoring DBP helps assess the stability of the cardiovascular system and ensure that the ESP block does not lead to significant hypotension or other adverse effects on circulation.

    Measured: Diastolic blood pressure (DBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.

  6. Mean Arterial Pressure (MAP) Monitoring in mmHg

    Mean arterial pressure (MAP) will be monitored preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours). MAP is a key indicator of perfusion pressure, ensuring adequate blood flow to organs. This outcome will evaluate whether the ESP block maintains stable MAP levels compared to conventional analgesic methods.

    Measured: Mean arterial pressure (MAP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.

Timeline

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

  1. First posted1 May 2026
  2. Study start1 Sep 2025
  3. Primary completion30 Jun 2026
  4. Study completion30 Jul 2026

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
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07560267
Sponsor's protocol ID
BSMMU/2025/2025
Status last verified
Sep 2026
First submitted
24 Apr 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yang JH, Sun Y, Yang YR, Qi LN, Li WY, Qin XZ. The Analgesic Mechanism and Recent Clinical Application of Erector Spinae Plane Block: A Narrative Review. J Pain Res. 2024 Sep 17;17:3047-3062. doi: 10.2147/JPR.S468560. eCollection 2024.

    PubMed 39308995
  • Yetneberk T, Chekol B, Teshome D. The efficacy of TAP block versus ilioinguinal block for post-cesarean section pain management: A systematic review and meta-analysis. Heliyon. 2021 Aug 13;7(8):e07774. doi: 10.1016/j.heliyon.2021.e07774. eCollection 2021 Aug.

    PubMed 34430749
  • Unal S, Baskan S, Guven Aytac B, Aytac I, Balci M. Should the Erector Spinae Plane Block Be Applied in the Pain Management of Percutaneous Nephrolithotomy? Cureus. 2022 Feb 24;14(2):e22554. doi: 10.7759/cureus.22554. eCollection 2022 Feb.

    PubMed 35345697
  • Rizkalla JM, Holderread B, Awad M, Botros A, Syed IY. The erector spinae plane block for analgesia after lumbar spine surgery: A systematic review. J Orthop. 2021 Feb 18;24:145-150. doi: 10.1016/j.jor.2021.02.006. eCollection 2021 Mar-Apr.

    PubMed 33716419
  • Rose TL, Kim WY. Renal Cell Carcinoma: A Review. JAMA. 2024 Sep 24;332(12):1001-1010. doi: 10.1001/jama.2024.12848.

    PubMed 39196544
  • Ni Y, Yang X. A Systematic Review and Meta-Analysis of Comparison of Outcomes of Robot-Assisted versus Open Partial Nephrectomy in Clinical T1 Renal Cell Carcinoma Patients. Urol Int. 2022;106(8):757-767. doi: 10.1159/000521881. Epub 2022 Feb 22.

    PubMed 35193139
  • Lavand'homme PM, Kehlet H, Rawal N, Joshi GP; PROSPECT Working Group of the European Society of Regional Anaesthesia and Pain Therapy (ESRA). Pain management after total knee arthroplasty: PROcedure SPEcific Postoperative Pain ManagemenT recommendations. Eur J Anaesthesiol. 2022 Sep 1;39(9):743-757. doi: 10.1097/EJA.0000000000001691. Epub 2022 Jul 20.

    PubMed 35852550
  • Aubrun F, Mazoit JX, Riou B. Postoperative intravenous morphine titration. Br J Anaesth. 2012 Feb;108(2):193-201. doi: 10.1093/bja/aer458.

    PubMed 22250276
  • Amr SA, Othman AH, Ahmed EH, Naeem RG, Kamal SM. Comparison between ultrasound guided erector spinae plane block and paravertebral block on acute and chronic post mastectomy pain after modified radical mastectomy: randomized controlled trial. BMC Anesthesiol. 2024 Nov 21;24(1):420. doi: 10.1186/s12871-024-02810-4.

    PubMed 39574036

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-Guided Erector Spinae Plane (ESP) Block in people with Erector Spinae Plane Block and Nephrectomy, run by Bangladesh Medical University at 1 site in Bangladesh.

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 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: finished, as of the sponsor's last update on 1 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 Bangladesh. 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?

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?

Visual Analogue Scale (VAS) for pain (time frame: VAS score will be The VAS score will be recorded within the first 24 hours after surgery upon the patient's arrival in recovery, at 1, 3, 6,12 and 24 hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07560267, which also lists 9 linked publications.

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 1 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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