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Completed

NCT Number: NCT04003909

Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries

ESP block advantages include its simplicity, easy identifiable ultrasonographic landmarks and low risk for serious complications as injection is into tissue plane that is distant from pleura, major blood vessels and discrete nerves. Coupled with the fact that the erector spinae muscle and ESP extend down to the lumbar spine, ESP block was hypothesized to be performed at the level of L4. In a recent case report, ultrasound guided ESP block was successfully performed at L4 transverse process level for postoperative analgesia after total hip arthroplasty. However, confirmation of the efficacy of ESP block in hip replacement surgeries needed more investigation.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anesthesia Department

Cairo, 1772, Egypt

About this study

This study will be performed in Cairo university hospital. Thirty adult patients of both sexes scheduled for hip replacement surgery under spinal anesthesia will be enrolled in the study.

All patients meeting the inclusion criteria will be randomly assigned to one of 2 groups, 15 per group:

Group E, ESP group (n=15): prior to surgical incision, patients will have ultrasound guided ESP block before spinal anesthesia.

Group C, Control group (n=15): prior to surgical incision, patients will have spinal Anesthesia without ESP block .

Patients will be randomly allocated by a computer-generated table into one of the study groups, the randomization sequence will be concealed in sealed opaque envelopes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged from 40 to 65 years old
  • Both sexes.
  • ASA I-II.
  • Undergo hip replacement surgery.
  • Body mass index (BMI) from 18 to 35 kg/m2.

Exclusion criteria

  • Patient refusal.
  • Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, etc. )
  • BMI > 35.
  • Known allergy to local anesthetics.
  • ASA III-IV.
  • Patients with difficulty in evaluating their level of pain.

Treatment and study plan

Ultrasound-Guided Erector Spinae Plane Block

Procedure

The patients will be in lateral position. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. Local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle will be inserted inplane to the ultrasound beam in a cranial-to-caudal direction until contact made with the L4 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will be confirmed by injecting 0.5-1ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total volume of 20ml bupivicaine 0.25% and 20 ml xylocaine 1% will be injected into the ESP on the affected side.

subarachonoid block

Procedure

Local anesthesia 2ml of lidocaine 2% will be applied intradermally to the needle entrance point. A 22-G block needle will be inserted, free cerebrospinal fluid flow will be observed and 20mg of hyperbaric bupivacaine 0.5% and 10μg of fentanyl will be injected for 30 seconds.

Primary outcomes

  1. Total morphine consumption

    Time frame: 24 hours postoperative

    Total morphine consumption in rescue boluses during 1st 24 hrs postoperatively.

Secondary outcomes

  1. Visual analogue scale

    Time frame: 30 minutes,2,4, 6, 12, and 24 hours postoperative.

    Visual analogue scale at the following intervals:30 minutes,2,4, 6, 12, and 24 hours postoperative.

  2. Duration of analgesia

    Time frame: 24 hours postoperative

    defined as the time interval from completion of local anesthetic administration till first need of rescue analgesic in the form of iv morphine

  3. Incidence of complications

    Time frame: 24 hours

    Nerve injury, Hematoma formation, LA toxicity, Intravascular injection.

Sponsors and collaborators

Lead sponsor

Bassant M. Abdelhamid

Other

Registry information

Official study title

Effectiveness of Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 1, 2019
Registry last updated
Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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