NCT06562634

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

August 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

1 month

First QC Date

August 14, 2024

Last Update Submit

February 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Total morphine consumption during the 1st 24 h postoperative.

    24 hour postoperative

Secondary Outcomes (7)

  • Intraoperative fentanyl consumption

    Intraoperative

  • Time to first postoperative analgesic request

    24hour postoperative

  • Visual analogue score (0-10)

    24hour postoperative

  • Hemodynamics :heart rate (bpm)

    baseline ,Intraoperative every 15 min, postoperative for 24 hr

  • Block failure rate.

    Intraoperative &24 hour postoperative

  • +2 more secondary outcomes

Study Arms (2)

Ultrasound-Guided Erector Spinae Plane Block

EXPERIMENTAL

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

Morphine

EXPERIMENTAL

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

Drug: Morphine Sulfate

Interventions

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.

Ultrasound-Guided Erector Spinae Plane Block

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

Morphine

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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 Ă— 109, Use of any anti-coagulants, local infection, etc.).
  • Known allergy to local anesthetics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy

Cairo, Egypt

Location

Related Publications (10)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Knee Injuries

Interventions

Morphine

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 20, 2024

Study Start

March 1, 2025

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

February 17, 2025

Record last verified: 2025-02

Locations