Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
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
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.
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.
Emergency preparedness measures included:
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group (S) Serratus Intercostal Plane Block: | Experimental | Patients in group (S) will receive ultrasound-guided serratus intercostal plane after induction of general anaesthesia by an experienced anaesthesiologist |
|
| Group (E) Erector Spinae Plane Block: | Experimental | Patients in group (E) will receive ultrasound-guided Erector spinae plane block after induction of general anaesthesia by an experienced anaesthesiologist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serratus Intercostal Plane Block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| • Postoperative pain score at rest 12 hours after surgery measured using the 0-10 Visual Analogue Scale (VAS). | VAS pain score (0-10 cm) (where 0=no pain and 10 = worst pain imaginable). | 12 hours post-surgery |
| 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. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hasnaa M Hashem, Master | Contact | 01064437956 | hm163@fayoum.edu.eg | |
| Amr H Mahmoud, MD | Contact | 01004349592 | amrhamdy69@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed A Hamed, MD | faculty of medicine, fayoum university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayoum university hospital | Recruiting | Al Fayyum | 084 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40254599 | Background | Alsmadi JK, Nofal MN, Alriyalat S, Yousef AJ. Laparoscopic vs. Open nephrectomy for inflammatory renal conditions: a meta-analysis emphasizing safety. BMC Urol. 2025 Apr 21;25(1):96. doi: 10.1186/s12894-025-01781-z. | |
| 40275145 | Background | Koksal BG, Baytar C, Bayraktar E, Balbaloglu H. Effects of serratus posterior superior intercostal plane block on postoperative analgesia in patients undergoing breast cancer surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Apr 24;25(1):209. doi: 10.1186/s12871-025-03092-0. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
douple blinded (The patients and outcome assessors will be blinded to group allocation).
|
| Erector Spinae Plane Block | Procedure | 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. |
|
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) | 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). | • 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). | • 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 | including nausea, vomiting, pruritus, and respiratory depression. | From surgery completion up to 24 hours post-surgery |
| • Incidence of block-related adverse events | such as vascular puncture or local anesthetic toxicity. | From start of nerve block until end of surgery |
| • Length of stay in the hospital. | post operative hospital stay | from date of surgery completion until the the date of hospital discharge, assessed up yo 30 days |
| Intraoperative opioid consumption. | 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 |
| 41310790 | Background | Wang J, Deng Y, Chen Q, Chen F, Li H. Acute postoperative pain management after cardiothoracic surgery: a bibliometric analysis and future directions. J Cardiothorac Surg. 2025 Nov 27;20(1):477. doi: 10.1186/s13019-025-03734-x. |
| 37876166 | Background | Mamoun MA, Alrefaey AK, Abo-Zeid MA. Continuous Serratus - Intercostal Plane Block for Perioperative Analgesia in Upper Abdominal Surgeries: A Prospective Randomized Controlled Study. Turk J Anaesthesiol Reanim. 2023 Oct 24;51(5):402-407. doi: 10.4274/TJAR.2023.231260. |
| 38799277 | Background | Liu QR, Dai YC, Ji MH, Liu PM, Dong YY, Yang JJ. Risk Factors for Acute Postsurgical Pain: A Narrative Review. J Pain Res. 2024 May 20;17:1793-1804. doi: 10.2147/JPR.S462112. eCollection 2024. |
| 31045789 | Background | Lee J, Kim S. The effects of ultrasound-guided serratus plane block, in combination with general anesthesia, on intraoperative opioid consumption, emergence time, and hemodynamic stability during video-assisted thoracoscopic lobectomy: A randomized prospective study. Medicine (Baltimore). 2019 May;98(18):e15385. doi: 10.1097/MD.0000000000015385. |
| 32431534 | Background | Song WQ, Wang W, Yang YC, Sun Q, Chen H, Zhang L, Bu XS, Zhan LY, Xia ZY. Parasternal Intercostal Block Complementation Contributes to Postoperative Pain Relief in Modified Radical Mastectomy Employing Pectoral Nerve Block I and Serratus-Intercostal Block: A Randomized Trial. J Pain Res. 2020 Apr 30;13:865-871. doi: 10.2147/JPR.S237435. eCollection 2020. |
| 36609244 | Background | Yang X, Zhang Y, Chen Y, Xu M, Lei X, Fu Q. Analgesic effect of erector spinae plane block in adults undergoing laparoscopic cholecystectomy: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2023 Jan 6;23(1):7. doi: 10.1186/s12871-023-01969-6. |
| 27100439 | Result | Alper I, Yuksel E. Comparison of Acute and Chronic Pain after Open Nephrectomy versus Laparoscopic Nephrectomy: A Prospective Clinical Trial. Medicine (Baltimore). 2016 Apr;95(16):e3433. doi: 10.1097/MD.0000000000003433. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |