NCT07556536

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Apr 2026

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 Progress7%
Apr 2026Jun 2027

Study Start

First participant enrolled

April 10, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

April 15, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

serratus intercostal plane blockErector spinae plane blockopen nephrectomy

Outcome Measures

Primary Outcomes (1)

  • • 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

Secondary Outcomes (9)

  • • Postoperative pain intensity assessed using the VAS at rest and during deep inspiration at the immediate postoperative period, 2, and 6 hours postoperatively.

    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

    12 hours post-surgery

  • • Block success rate (dermatomal sensory loss)

    30 minutes After arrival in Post-Anaesthesia Care Unit (PACU)

  • • Cumulative morphine consumption in 24 hours (in mg).

    From surgery completion up to 24 hours post-surgery

  • • Time to first request for rescue analgesia (in hours).

    From surgery completion up to 24 hours post-surgery

  • +4 more secondary outcomes

Study Arms (2)

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

Procedure: Serratus Intercostal Plane Block

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

Procedure: Erector Spinae Plane Block

Interventions

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 (S) Serratus Intercostal 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.

Group (E) Erector Spinae Plane Block:

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum university hospital

Al Fayyum, 084, Egypt

RECRUITING

Related Publications (9)

  • 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.

    PMID: 40254599BACKGROUND
  • 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.

    PMID: 40275145BACKGROUND
  • 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.

    PMID: 41310790BACKGROUND
  • 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.

    PMID: 37876166BACKGROUND
  • 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.

    PMID: 38799277BACKGROUND
  • 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.

    PMID: 31045789BACKGROUND
  • 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.

    PMID: 32431534BACKGROUND
  • 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.

    PMID: 36609244BACKGROUND
  • 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.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Mohamed A Hamed, MD

    faculty of medicine, fayoum university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasnaa M Hashem, Master

CONTACT

Amr H Mahmoud, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
douple blinded (The patients and outcome assessors will be blinded to group allocation).
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia, Surgical ICUS &Pain Management

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 29, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations