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

NCT04003909 | Completed DMC

• 1 other identifier: N-147-2018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

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

  24 hours postoperative

Secondary Outcomes (3)

• Visual analogue scale

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

• Duration of analgesia

  24 hours postoperative

• Incidence of complications

  24 hours

Study Arms (2)

ESP group

EXPERIMENTAL

patients will have ultrasound guided ESP block before spinal anesthesia.

Procedure: ultrasound-guided Erector spinae plane block; Procedure: subarachonoid block

Control group

EXPERIMENTAL

patients will have spinal Anesthesia without ESP block

Procedure: subarachonoid block

Interventions

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.

ESP group

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.

Control group; ESP group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bassant M. Abdelhamid: lead

Study Sites (1)

Anesthesia Department

Cairo, 1772, Egypt

Location

Related Publications (4)

• Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.

  PMID: 29522966 BACKGROUND

• Ueshima H, Otake H. RETRACTED: Clinical experiences of ultrasound-guided erector spinae plane block for thoracic vertebra surgery. J Clin Anesth. 2017 May;38:137. doi: 10.1016/j.jclinane.2016.12.028. Epub 2017 Feb 17. No abstract available.

  PMID: 28372654 BACKGROUND

• Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.

  PMID: 28203765 BACKGROUND

• Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

  PMID: 29913392 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Ashraf Rady, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

• Amr abdelnasser

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 1, 2019
• Study Start: July 5, 2019
• Primary Completion: October 5, 2019
• Study Completion: November 6, 2019
• Last Updated: November 7, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)