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

NCT ID: NCT06562634

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-04-30

Brief Summary

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

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.

Conditions

Knee Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

erector spinea plane block

Intervention Type: PROCEDURE

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.

Morphine

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

Group Type: EXPERIMENTAL

Morphine Sulfate

Intervention Type: DRUG

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

Interventions

erector 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.

Intervention Type: PROCEDURE

Morphine Sulfate

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

Intervention Type: DRUG

Eligibility Criteria

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

• • 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Noha Sameh Darwish

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Alainy

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: RESULT

PMID: 9661552 (View on PubMed)

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.

Reference Type: RESULT

PMID: 8155433 (View on PubMed)

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.

Reference Type: RESULT

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Reference Type: RESULT

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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.

Reference Type: RESULT

PMID: 11402405 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27501016 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28188621 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31684742 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18344573 (View on PubMed)

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.

Reference Type: RESULT

PMID: 1934205 (View on PubMed)

Other Identifiers

ESPB in knee surgeries

Identifier Type: -

Identifier Source: org_study_id