NCT07560267

Brief 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). 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: 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Sep 2025Jul 2026

Study Start

First participant enrolled

September 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

Erector Spinae Plane Block (ESP)Postoperative Pain ManagementOpioid ConsumptionNephrectomy

Outcome Measures

Primary Outcomes (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.

    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)

  • Total Opioid Consumption

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

  • Peak Expiratory Flow Rate (PEFR)

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

  • Heart Rate (HR) Monitoring

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

  • Systolic Blood Pressure (SBP) Monitoring in mmHg

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

  • Diastolic Blood Pressure (DBP) Monitoring in mmHg

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

  • +1 more secondary outcomes

Study Arms (2)

Control Group: Conventional Pain Management

NO INTERVENTION

This 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 Block

EXPERIMENTAL

Patients 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.

Procedure: Ultrasound-Guided Erector Spinae Plane (ESP) Block

Interventions

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.

Intervention Group: Ultrasound-Guided Erector Spinae Plane Block

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

RECRUITING

Related Publications (9)

  • 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.

    PMID: 39308995BACKGROUND
  • 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.

    PMID: 34430749BACKGROUND
  • 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.

    PMID: 35345697BACKGROUND
  • 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.

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

    PMID: 39196544BACKGROUND
  • 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.

    PMID: 35193139BACKGROUND
  • 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.

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

    PMID: 22250276BACKGROUND
  • 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.

    PMID: 39574036BACKGROUND

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

ParapsychologyDental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral SciencesBehavioral Disciplines and ActivitiesDentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • AKM Akhtaruzzaman, MD

    Bangladesh Medical University

    STUDY DIRECTOR

Central Study Contacts

Kazi Mahzabin Arin, MD

CONTACT

AKM Akhtaruzzaman, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol (pain.medicine@bsmmu.edu.bd)Access

Locations