Comparison Between the Analgesic Efficacy of Erector Spinae Plane Block and Psoas Compartment Block in Hip Surgery

NCT03904095 | Unknown

• 1 other identifier: 2019/98
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the ability of Erector spina Plane block and Psoas compartment block to decrease postoperative pain and analgesia requirements in patients undergoing hip surgery.

Conditions

Hip Arthropathy

Keywords

Erector spinae block; hip arthroplasty; postoperative analgesia; psoas compartment block; ultrasound

Outcome Measures

Primary Outcomes (2)

• opioid consumption

  In the recovery room, all patients will given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 15 min lockout time and 6 mg 1 h limit.Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).

  24 hours after surgery

• Verbal analog Pain Scores on rest and movement

  A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.

  24 hours after surgery

Secondary Outcomes (1)

• incidences of adverse effects (like nausea and vomiting)

  24 hours after surgery

Study Arms (3)

Psoas compartment block group (PCB)

ACTIVE COMPARATOR

Single- shot ultrasound (Esaote Mylab30) guided PCB with 15 ml 0.25% bupivacain ( Marcain 0.5%, Astra zeneca, Turkey) at the L4 vertebral level will performed preoperatively to patients in the PCB group (Group I).

Procedure: Psoas Compartment Block Group (GROUP I)

Erector spinae plane block group (ESP)

ACTIVE COMPARATOR

Single- shot ultrasound (Esaote Mylab30) guided ESP block with 15 ml 0.25% ( Marcain 0.5%, Astra zeneca, Turkey) at the L4 vertebral level will performed preoperatively to patients in the ESP group (Group II).

Procedure: Erector Spinae Plane block ( Group II)

The Control group

PLACEBO COMPARATOR

The Control group receive no intervention ( Group III).

Procedure: Control Group (GROUP III)

Interventions

Psoas Compartment Block Group (GROUP I) PROCEDURE

Psoas Compartment Block will perform preoperative to all patients in Group I. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

Psoas compartment block group (PCB)

Erector Spinae Plane block ( Group II) PROCEDURE

ESP Block will perform preoperative to all patients in ESP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

Erector spinae plane block group (ESP)

Control Group (GROUP III) PROCEDURE

Control group will receive no intervention. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

The Control 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:

• ASA (American Society of Anesthesiologists) I- ASA II Patients

You may not qualify if:

• history of allergy to the study medication
• refusal to participate

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Sibel Seçkin Pehlivan

Kayseri, Talas, 38039, Turkey (Türkiye)

Location

Related Publications (3)

• Touray ST, de Leeuw MA, Zuurmond WW, Perez RS. Psoas compartment block for lower extremity surgery: a meta-analysis. Br J Anaesth. 2008 Dec;101(6):750-60. doi: 10.1093/bja/aen298. Epub 2008 Oct 22.

  PMID: 18945717 RESULT

• Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.

  PMID: 30292068 RESULT

• Tulgar S, Ermis MN, Ozer Z. Combination of lumbar erector spinae plane block and transmuscular quadratus lumborum block for surgical anaesthesia in hemiarthroplasty for femoral neck fracture. Indian J Anaesth. 2018 Oct;62(10):802-805. doi: 10.4103/ija.IJA_230_18.

  PMID: 30443064 RESULT

Related Links

• Related Info

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sibel Pehlivan

  TC Erciyes University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: participant care provider
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Model Details: Patients randomly allocated to three treatment groups: , The psoas compartment block (Group I) the ESP block group (Group II) and the control group (Group III). Blocks performed after general anesthesia induction with the Ultrasound while patients lying on surgical type at the top.

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 4, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 12 months of study completion
• Access Criteria: Data accept requests will be reviewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement.

Locations

TU (1)