Efficacy of Ultrasound-Guided Erector Spinae Block for Postoperative Pain Management in Nephrectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBangladesh Medical University
About this 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:
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound-Guided Erector Spinae Plane (ESP) Block
Procedure/SurgeryThe 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Control Group: Conventional Pain ManagementNo intervention 0 interventions
Group B: Intervention Group: Ultrasound-Guided Erector Spinae Plane BlockExperimental treatment 1 intervention
Trial outcomes
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.
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 outcomes
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.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
Systolic blood pressure (SBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.Sponsors and contacts
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Source ClinicalTrials.gov