Comparison of Serratus Intercostal Plane Blcok With Erector Spinae Plane Block for Open Nephrectomy

April 22, 2026 updated by: Mohamed Ahmed Hamed, Fayoum University Hospital

Analgesic Efficacy of Ultrasound-Guided Serratus Intercostal Plane Block Versus Erector Spinae Plane Block for Postoperative Pain Control After Open Nephrectomy: A Prospective Randomized Controlled Trial

Effective postoperative pain management following open nephrectomy remains a significant clinical challenge.

Inadequate pain control after this procedure may lead to impaired respiratory function, delayed mobilization, prolonged hospital stay, increased opioid consumption, and a higher incidence of postoperative complications. Therefore, optimizing postoperative analgesia while minimizing opioid-related adverse effects is a key objective in perioperative care for patients undergoing open nephrectomy Traditionally, postoperative pain following open nephrectomy has been managed using systemic opioids, epidural analgesia, or paravertebral blocks.

Ultrasound-guided fascial plane blocks have emerged as valuable alternatives in modern regional anesthesia due to their simplicity, safety profile, and effectiveness. Among these techniques, the erector spinae plane (ESP) block has gained widespread popularity.

This block has been shown to provide effective analgesia for thoracic, abdominal, and urologic surgeries, including nephrectomy The ultrasound-guided serratus intercostal plane block (SIPB) is a more recently described regional anesthetic technique targeting the lateral cutaneous branches of the intercostal nerves by injecting local anesthetic between the serratus anterior muscle and the intercostal muscles or ribs By blocking these nerves, SIPB provides analgesia to the lateral thoracic wall and upper abdominal regions, which are particularly relevant to flank incisions used in open nephrectomy.

Patients will be randomly allocated into two equal groups. Patients in group (S) will receive serratus intercostal plane block and those in group (E) will receive Erector spinae plane block . Both of these blocks will be performed after induction of general anaesthesia by an experienced anaesthesiologist The aim of this study is to to compare the analgesic efficacy of ultrasound-guided serratus intercostal plane block and erector spinae plane block in patients undergoing open nephrectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This double-blinded, prospective, randomized comparative study will be conducted in Fayoum University hospital after the approval of local Institutional Ethics Committee and local institutional review board. Written informed consent will be obtained from all patients for these scientific contributions before recruitment and randomization.

Patients will be randomly allocated into two equal groups using a computer-generated randomization sequence with a 1:1 allocation ratio. Group assignments will be concealed in sealed opaque envelopes opened immediately before block performance. The patients (as block will be given after induction of general anesthesia) and outcome assessors will be blinded to group allocation. The anesthesiologist performing the block will not participate in data collection or postoperative assessment.

All patients will receive standardized general anesthesia. Following induction of anesthesia and before surgical incision, the assigned regional block will be performed under ultrasound guidance using strict aseptic precautions.

Preoperative assessment Complete history taking, physical examination and investigation will be done according to hospital protocol to evaluate the patients, Which includes complete blood count, serum urea and creatinine, liver function tests, coagulation profile, electrocardiogram (ECG) and ECHO when clinically indicated and based on patient medical condition and perioperative risk assessment.

Before surgery, details of the nerve block procedures and the VAS pain score (0-10 cm) will be illustrated to the patients (where 0=no pain and 10 = worst pain imaginable).

An informed consent will be obtained from participants. Patients will fast for about 6 hours for solid meals, 4 hours for non-clear liquids and 2 hours for clear liquids before surgery Anesthetic technique

  • Intravenous access with a 18-gauge intravenous (IV) cannula will be inserted in the hand and standard monitoring (noninvasive blood pressure, electrocardiography, pulse oximetry and capnography ) will be applied.
  • All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with target of EtCo2≈ 35-40 mmHg, isoflurane 1 minimum alveolar concentration (MAC), 0.5μg/kg fentanyl will be given intraoperative when either heart rate or NIBP report an increase by more than 20% of the basal record. The standardized rescue protocol will be applied by independent anesthesiologist unaware of study hypothesis
  • At the end of the operation, Anesthesia will be discontinued and extubation will be done once patient fulfilled the extubation criteria.

Block techniques Patients in group (S) will receive serratus intercostal plane block and those in group (E) will receive Erector spinae plane block . Both of these blocks will be performed after induction of general anaesthesia by an experienced anaesthesiologist

Group (S) Serratus Intercostal Plane Block:

Block will be performed in the operating room, With the patient in the supine decubitus position, aseptic conditions were provided for the block, The high-frequency linear transducer of ultrasound (LOGIQ P7) will be placed in the mid-axillary line at the level of the eighths rib. The serratus anterior muscle and underlying intercostal muscles will be identified. A 22-gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany) will be advanced in plane in the caudo-cranial direction. After negative aspiration, 25 mL of 0.25% bupivacaine HCl (plain)will be injected between the serratus anterior muscle and the intercostal muscles.

Group (E) Erector Spinae Plane Block:

Block will be performed in the operating room, With the patient in the lateral decubitus position, Aseptic conditions were provided for the block, The high-frequency linear transducer of ultrasound (LOGIQ P7) will be placed parasagittally at the level of the T8-T10 transverse process. The erector spinae muscle and transverse process will be identified. A 22-gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany) will be advanced in plane in the cranio-caudal direction and after negative aspiration, 25 mL of 0.25% bupivacaine HCl (plain) will be injected deep to the erector spinae muscle.

Local Anesthetic Dose, Safety, and Emergency Preparedness

  1. Dose: 25 mL of 0.25% bupivacaine HCl (plain), equivalent to 62.5 mg. The maximum safe dose of plain bupivacaine will be strictly adhered to, defined as 2 mg/kg, not exceeding an absolute maximum of 150 mg.
  2. Slow Incremental Injection: The standard practice is to inject the local anesthetic under ultrasound guidance in small boluses, commonly 5-10 mL at a time, followed by aspiration to rule out intravascular placement and systemic toxicity.

  3. Emergency preparedness measures included:

    • Lipid rescue protocol availability: 20% Intralipid solution will be readily available for immediate intravenous administration in the event of local anesthetic systemic toxicity (LAST), according to ASRA guidelines.
    • Allergic/anaphylaxis management: Emergency medications (adrenaline, antihistamines, corticosteroids) and resuscitation equipment will be available, with a predefined protocol for prompt management of any hypersensitivity reactions.
    • Stop rule will be applied if unexpected adverse events (e.g., severe hypotension, arrhythmia, LA toxicity).

Block Success Assessment

After recovery from anesthesia (PACU):

Cold sensation test using alcohol swab at T7-T12 dermatomes. Block considered successful if ≥3 dermatomes sensory loss within 30 min. Failed blocks will be recorded and analyzed

Postoperative Analgesia

  • Routine Analgesia: Paracetamol (1 g every 6 hours) will be administered intravenously as a baseline routine analgesic.
  • Rescue analgesia will be administered via intravenous morphine using a PCA pump programmed to deliver 1 mg per demand with a 10-minute lockout interval and no basal infusion. Cumulative 24-hour morphine consumption will be recorded.

Sample size calculation The sample size was calculated using G*Power software (version 3.1.9.7) based on the primary outcome measure: VAS pain score at rest and during deep inspiration at 12 hours postoperatively. Based on data from Fernandez Martin et al. (2025), who compared SIPB with posterior quadratus lumborum block in laparoscopic nephrectomy and reported a mean NRS score of 2.35 (±1.92) in the SIPB group at 12 hours, and from Wadood et al. (2024), who reported a median NRS score of 3.0 in the ESPB group at 12 hours in open nephrectomy. the investigators estimated the mean and standard deviation in the ESPB group to be 3.24 (±1.47) based on Luo et al. (2018) and Wan et al. (2014).

Using a two-sided independent samples t-test with a type I error (α) of 0.05 and a statistical power (1-β) of 80%, a minimum of 59 patients per group was calculated to be required. Accounting for an anticipated dropout rate of approximately 10%, the total sample size was increased to 66 patients per group, yielding a final target enrollment of 132 patients in total. The calculation was based on the following parameters: effect size d = 0.524, α = 0.05 (two-tailed), power = 0.80, and equal allocation ratio (1:1).

Statistical Analysis Data will be collected and analyzed using IBM SPSS Statistics for Windows, Version 26.0 (IBM Corp., Armonk, NY, USA). Continuous variables will be expressed as mean ± standard deviation (SD) or median with interquartile range (IQR), depending on the normality of data distribution. Categorical variables will be presented as frequencies and percentages. Normality of distribution will be assessed using the Shapiro-Wilk test.

For normally distributed continuous data, comparisons between the two groups will be performed using the independent samples Student's t-test. For non-normally distributed continuous data, the Mann-Whitney U test will be used. Categorical variables will be compared using the Chi-square test or Fisher's exact test, as appropriate. Repeated measurements over time (e.g., VAS scores at multiple postoperative time points) will be analyzed using a repeated-measures analysis of variance (ANOVA) or the Friedman test for non-parametric data, with appropriate post-hoc corrections (Bonferroni) for multiple comparisons.

The primary outcome (VAS score at rest at 12 hours postoperatively) will be the main variable for inferential testing. Time to first rescue analgesia will be analyzed using Kaplan-Meier survival analysis and compared between groups using the log-rank test. All tests will be two-tailed.

Effect size with 95% CI reported A p-value of less than 0.05 will be considered statistically significant.

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Al Fayyum, Egypt, 084
        • Recruiting
        • Fayoum University hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients scheduled for elective open nephrectomy under general anesthesia via flank incision .
  2. Adult patients aged 18-65 years.
  3. Patients with an American Society of Anesthesiologists (ASA) physical status I to III.

Exclusion Criteria:

  1. Patient refusal.
  2. Allergy to local anesthetics and patient with infection at the injection site of block.
  3. Coagulation disorders or ongoing anticoagulant therapy.
  4. Patients receiving opioids for chronic analgesic therapy (cancer, addiction).
  5. Cognitive impairment preventing pain scoring.
  6. Neurological or psychiatric disorders affecting pain assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group (S) Serratus Intercostal Plane Block:
Patients in group (S) will receive ultrasound-guided serratus intercostal plane after induction of general anaesthesia by an experienced anaesthesiologist
Procedure: Serratus Intercostal Plane Block
Block will be performed in the operating room, With the patient in the supine decubitus position, aseptic conditions were provided for the block, The high-frequency linear transducer of ultrasound (LOGIQ P7) will be placed in the mid-axillary line at the level of the eighths rib. The serratus anterior muscle and underlying intercostal muscles will be identified. A 22-gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany) will be advanced in plane in the caudo-cranial direction. After negative aspiration, 25 mL of 0.25% bupivacaine HCl (plain)will be injected between the serratus anterior muscle and the intercostal muscles.
Experimental: Group (E) Erector Spinae Plane Block:
Patients in group (E) will receive ultrasound-guided Erector spinae plane block after induction of general anaesthesia by an experienced anaesthesiologist
Procedure: Erector Spinae Plane Block
Block will be performed in the operating room, With the patient in the lateral decubitus position, Aseptic conditions were provided for the block, The high-frequency linear transducer of ultrasound (LOGIQ P7) will be placed parasagittally at the level of the T8-T10 transverse process. The erector spinae muscle and transverse process will be identified. A 22-gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany) will be advanced in plane in the cranio-caudal direction and after negative aspiration, 25 mL of 0.25% bupivacaine HCl (plain) will be injected deep to the erector spinae muscle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Postoperative pain score at rest 12 hours after surgery measured using the 0-10 Visual Analogue Scale (VAS).
Time Frame: 12 hours post-surgery
VAS pain score (0-10 cm) (where 0=no pain and 10 = worst pain imaginable).
12 hours post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Postoperative pain intensity assessed using the VAS at rest and during deep inspiration at the immediate postoperative period, 2, and 6 hours postoperatively.
Time Frame: 0, 2, and 6 hours after surgery completion
VAS pain score (0-10 cm) (where 0=no pain and 10 = worst pain imaginable).
0, 2, and 6 hours after surgery completion
• Postoperative pain intensity assessed using the visual analogue scale (VAS) during deep inspiration at 12 hours postoperatively
Time Frame: 12 hours post-surgery
VAS pain score (0-10 cm) (where 0=no pain and 10 = worst pain imaginable). during deep expiration
12 hours post-surgery
• Block success rate (dermatomal sensory loss)
Time Frame: 30 minutes After arrival in Post-Anaesthesia Care Unit (PACU)

After recovery from anesthesia (PACU):

Cold sensation test using alcohol swab at T7-T12 dermatomes. Block considered successful if ≥3 dermatomes sensory loss within 30 min. Failed blocks will be recorded and analyzed
30 minutes After arrival in Post-Anaesthesia Care Unit (PACU)
• Cumulative morphine consumption in 24 hours (in mg).
Time Frame: From surgery completion up to 24 hours post-surgery
• Rescue analgesia will be administered via intravenous morphine using a PCA pump programmed to deliver 1 mg per demand with a 10-minute lockout interval and no basal infusion. Cumulative 24-hour morphine consumption will be recorded
From surgery completion up to 24 hours post-surgery
• Time to first request for rescue analgesia (in hours).
Time Frame: From surgery completion up to 24 hours post-surgery
• Rescue analgesia will be administered via intravenous morphine using a PCA pump programmed to deliver 1 mg per demand with a 10-minute lockout interval and no basal infusion.
From surgery completion up to 24 hours post-surgery
• Incidence of opioid-related side effects
Time Frame: From surgery completion up to 24 hours post-surgery
including nausea, vomiting, pruritus, and respiratory depression.
From surgery completion up to 24 hours post-surgery
• Incidence of block-related adverse events
Time Frame: From start of nerve block until end of surgery
such as vascular puncture or local anesthetic toxicity.
From start of nerve block until end of surgery
• Length of stay in the hospital.
Time Frame: from date of surgery completion until the the date of hospital discharge, assessed up yo 30 days
post operative hospital stay
from date of surgery completion until the the date of hospital discharge, assessed up yo 30 days
Intraoperative opioid consumption.
Time Frame: from start of surgery up to surgery completion
fentanyl will be given intraoperative when either heart rate or NIBP report an increase by more than 20% of the basal record.
from start of surgery up to surgery completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University Hospital

Investigators

  • Principal Investigator: Mohamed A Hamed, MD, Faculty of medicine, Fayoum university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D 470

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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