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Enrolling by invitationNCT06562634Updated Feb 17, 2025

Effectiveness of Ultrasound-Guided Erector Spinae Plane Block for Postoperative Pain Control in Open Knee Surgeries

An interventional study of erector spinea plane block and Morphine Sulfate in Knee Injuries, sponsored by Cairo University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-17.

Sponsored by Cairo University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To estimate the efficacy of the ultrasound guided ESP block for postoperative pain control in open knee surgeries under general anesthesia.

Read the detailed description

Postoperative pain is a major concern after knee surgeries. It is severe in 60% of patients and moderate in 30%. When inadequately treated, it intensifies reflex responses, which leads to cause serious complications, such as cardiovascular, pulmonary or urinary problems, thromboembolism, increased oxygen consumption, hyperdynamic circulation and hinders early physical therapy. Generally it has been assumed that adequate postoperative pain relief may reduce these complications, and improve general postoperative outcome.

In the last decade Improvements in pain management techniques have had a major impact on the practice of knee surgeries. Although there are a number of treatment options for postoperative pain, a gold standard has not been established. Patient-controlled analgesia (PCA), epi¬dural analgesia and lumbar plexus and/or sciatic blocks are the commonly used routes for pain relief after joint surgery .Each of those options has advantages and disadvantages. PCA has fewer technical problems, uniform and sustained analgesia with autonomy, however it might lead to respiratory depression, nausea and vomiting. Epidural analgesia is an efficient route for postoperative analgesia ; however it is associated with technical failures, hypotension, urinary retention, and ileus, motor block that limits ambulation, unrecognized compartment syndromes, and spinal hematoma secondary to anticoagulation.

The ultrasound-guided erector spinae plane (ESP) block is a recently described regional anesthetic technique for providing thoracic analgesia when performed at the level of T5 transverse process. Local anesthetic is injected into the fascial plane deep to the erector spinae muscle, and spreads craniocaudally over several levels can lead to effective analgesia and sensory block from T2 to T9. Local anesthetic also penetrates anteriorly through the intertransverse connective tissue and enters the thoracic paravertebral space where it can potentially block not only the ventral and dorsal rami of spinal nerves but also the rami communicantes that transmit sympathetic fibers.

ESP advantages include its simplicity, easy identifiable ultrasonographic landmarks and an endpoint for injection and low risk for serious complications as injection is into tissue plane that is distant from pleura, major blood vessels and discrete nerves.

There is clinical report of two cases shows the ESP block may be a safe, simple and effective technique for analgesia following surgery around the knee.

However, confirmation of the efficacy of ESP block in knee surgeries needs more investigation.

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Conditions studied

  • Knee Injuries

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In context

Knee Injuries

249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.

This study's planned enrollment of 40 is below the median of 50 across 160 interventional studies indexed under Knee Injuries.

Browse Knee Injuries studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    • Patients aged from 18 to 60 years old.

      • Genders eligible for study: both sexes.
      • ASA I-II.
      • Undergo knee surgery.
      • BMI from 18 to 35 kg/m2.

Exclusion criteria

Exclusion Criteria:

    • Patient refusal.

      • Patients with difficulty in evaluating their level of pain.
      • Contraindications to regional anesthesia (Bleeding disorders e.g. INR>1.5, PC\<70%, platelet count\<100 × 109, Use of any anti-coagulants, local infection, etc.).
      • Known allergy to local anesthetics.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Ultrasound-Guided Erector Spinae Plane Block

    The patient will be placed in a prone position. A convex-array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process .The tip of the transverse process is centered on the ultrasound screen and the probe is then rotated into a longitudinal orientation 2-3 cm lateral to vertebral column, in which the following layers will be visible superficial to the acoustic shadows of the transverse processes: skin, subcutaneous tissue, erector spinae muscle and psoas muscle. The lumbar skin region will be sterilized, local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle is inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact was made with the L4 transverse process. A total of 20ml bupivicaine 0.25%, and 20 ml xylocaine 1% will be injected into the ESP on the affected side.

    Procedure: erector spinea plane block

  • Experimental
    Morphine

    intravenous morphine will be given in a dose of 0.1-0.2mg/kg to maintain intraoperative analgesia.

    Drug: Morphine Sulfate

Interventions

  • Procedureerector spinea plane block

    an echogenic 22-G block needle is inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact was made with the L4 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle is confirmed by injecting 0.5-1 ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total of 20ml bupivicaine 0.25%, and 20 ml xylocaine 1% will be injected into the ESP on the affected side.

  • DrugMorphine Sulfate

    intravenous morphine will be given in a dose of 0.1-0.2mg/kg to maintain intraoperative analgesia.

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What researchers measure

Primary outcomes

  1. Total morphine consumption during the 1st 24 h postoperative.

    Total morphine consumption during the 1st 24 h postoperative.

    Time frame: 24 hour postoperative

Secondary outcomes

  1. Intraoperative fentanyl consumption

    Time frame: Intraoperative

  2. Time to first postoperative analgesic request

    Time frame: 24hour postoperative

  3. Visual analogue score (0-10)

    0: no pain 10:worst pain

    Time frame: 24hour postoperative

  4. Hemodynamics :heart rate (bpm)

    Time frame: baseline ,Intraoperative every 15 min, postoperative for 24 hr

  5. Block failure rate.

    Time frame: Intraoperative &24 hour postoperative

  6. Incidence of complications. (Nerve injury, Hematoma formation, LA toxicity, Intravascular injection

    Time frame: 24hour postoperative

  7. Hemodynamics :arterial blood pressure (systolic, diastolic and mean blood pressure) in mmhg

    Time frame: baseline, intraoperative every 15 min, postoperative for 24 hr

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Study locations

1 site
  • Kasr Alainy
    Cairo, Egypt
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References and documents

Publications

  • Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019. PubMed 9661552 ↗
  • Kehlet H. Postoperative pain relief--what is the issue? Br J Anaesth. 1994 Apr;72(4):375-8. doi: 10.1093/bja/72.4.375. No abstract available. PubMed 8155433 ↗
  • Maheshwari AV, Blum YC, Shekhar L, Ranawat AS, Ranawat CS. Multimodal pain management after total hip and knee arthroplasty at the Ranawat Orthopaedic Center. Clin Orthop Relat Res. 2009 Jun;467(6):1418-23. doi: 10.1007/s11999-009-0728-7. Epub 2009 Feb 13. PubMed 19214642 ↗
  • Sinatra RS, Torres J, Bustos AM. Pain management after major orthopaedic surgery: current strategies and new concepts. J Am Acad Orthop Surg. 2002 Mar-Apr;10(2):117-29. doi: 10.5435/00124635-200203000-00007. PubMed 11929206 ↗
  • Chelly JE, Greger J, Gebhard R, Coupe K, Clyburn TA, Buckle R, Criswell A. Continuous femoral blocks improve recovery and outcome of patients undergoing total knee arthroplasty. J Arthroplasty. 2001 Jun;16(4):436-45. doi: 10.1054/arth.2001.23622. PubMed 11402405 ↗
  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. PubMed 27501016 ↗
  • Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11. PubMed 28188621 ↗
  • Ayub A, Talawar P, Gupta SK, Kumar R, Alam A. Erector spinae plane block: A safe, simple and effective alternative for knee surgery. Anaesth Intensive Care. 2019 Sep;47(5):469-471. doi: 10.1177/0310057X19877655. Epub 2019 Nov 4. No abstract available. PubMed 31684742 ↗
  • Karmakar MK, Ho AM, Li X, Kwok WH, Tsang K, Ngan Kee WD. Ultrasound-guided lumbar plexus block through the acoustic window of the lumbar ultrasound trident. Br J Anaesth. 2008 Apr;100(4):533-7. doi: 10.1093/bja/aen026. PubMed 18344573 ↗
  • Weller R, Rosenblum M, Conard P, Gross JB. Comparison of epidural and patient-controlled intravenous morphine following joint replacement surgery. Can J Anaesth. 1991 Jul;38(5):582-6. doi: 10.1007/BF03008188. PubMed 1934205 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06562634
Lead sponsor
Cairo University
Responsible party
Noha Sameh Darwish (Principal investigator, Cairo University) — Principal investigator
First posted
Aug 20, 2024
Start date
Mar 1, 2025 (estimated)
Primary completion
Apr 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Feb 17, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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