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

Official title

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

Overview

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

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.

Interventions

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

Primary outcome measures

• 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.]

Secondary outcome measures (6)

• Total Opioid Consumption [Time frame: Total opioid consumption will be calculated and recorded in mg within the first 24 hours postoperatively.]
• Peak Expiratory Flow Rate (PEFR) [Time frame: PEFR values will be assessed preoperatively and at arrival to 1, 3, 6, and 24 hours postoperatively.]
• Heart Rate (HR) Monitoring [Time frame: 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 [Time frame: 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 [Time frame: Diastolic blood pressure (DBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.]
• Mean Arterial Pressure (MAP) Monitoring in mmHg [Time frame: Mean arterial pressure (MAP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Bangladesh · 1 center

• Bangladesh Medical University — Dhaka

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. PMID 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. PMID 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. PMID 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. PMID 33716419
• Rose TL, Kim WY. Renal Cell Carcinoma: A Review. JAMA. 2024 Sep 24;332(12):1001-1010. doi: 10.1001/jama.2024.12848. PMID 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. PMID 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. PMID 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. PMID 22250276

Identifiers

NCT: NCT07560267 · BSMMU/2025/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗