ESPB vs FICB for Pain Management Following Total Hip Prosthesis Surgery

Sponsor
Mursel Ekinci (Other)
Overall Status
Recruiting
CT.gov ID
NCT05621161
Collaborator
(none)
60
1
2
4.5
13.2

Study Details

Study Description

Brief Summary

Hip arthroplasty surgery is frequently performed on elderly patients in the community and it is associated with long-term postoperative hospital stays and high mortality.

Postoperative pain management is a multimodal process that includes intravenous and regional anesthesia methods. The ultrasound(US) guided erector spinae plane block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. In the literature, it has been reported that ESPB provides effective analgesia after a hip surgery. The fascia iliaca compartment block (FICB) is a safe method used for postoperative analgesia following hip, femoral, and knee surgeries.

The aim of this study is to compare US-guided FICB and ESPB for postoperative analgesia management after total hip prosthesis surgery.

Condition or Disease Intervention/Treatment Phase
  • Drug: Postoperative analgesia management
N/A

Detailed Description

Hip arthroplasty surgery is frequently performed on elderly patients in the community and it is associated with long-term postoperative hospital stays and high mortality. Severe postoperative pain may further reduce the limited cardiopulmonary capacity, especially in the elderly population. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced.

Postoperative pain management is a multimodal process that includes intravenous and regional anesthesia methods. Parenteral opioids are generally preferred in the management of acute postoperative pain. However, opioids have undesired adverse events such as nausea, vomiting, itching, sedation, and respiratory depression (opioid-related adverse events). Regional anesthesia techniques are frequently preferred as a part of multimodal analgesia in hip surgeries. Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment. US-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice.

The ultrasound(US) guided erector spinae plane block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. Visualization of sonoanatomy with the US is simple and the spread of local anesthetic solution can be seen easily in the deep fascia of the erector spinae. Visualization of sonoanatomy in the US is easy, and the spread of local anesthetic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. Cadaveric studies have shown that the injection spreads to the ventral and dorsal roots of the spinal nerves. In the literature, it has been reported that ESPB provides effective analgesia after a hip surgery. The fascia iliaca compartment block (FICB) is a safe method used for postoperative analgesia following hip, femoral, and knee surgeries.

The aim of this study is to compare US-guided FICB and ESPB for postoperative analgesia management after total hip prosthesis surgery. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), and adverse effects related to opioids (allergic reaction, nausea, vomiting).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
There are two models for this study. Fascia iliaca compartment block (FICB) group, and Erector spinae plane block (ESPB) groupThere are two models for this study. Fascia iliaca compartment block (FICB) group, and Erector spinae plane block (ESPB) group
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group
Primary Purpose:
Treatment
Official Title:
Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block And Fascia Iliaca Compartment Block for Pain Management Following Total Hip Prosthesis Surgery
Actual Study Start Date :
Nov 28, 2022
Anticipated Primary Completion Date :
Mar 15, 2023
Anticipated Study Completion Date :
Apr 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: GroupFICB= fascia iliaca compartment block

ESP block will be performed. US probe will be placed longitudinally 2-3 cm lateral to the L3 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and then for correction of the needle 2 ml saline will be injected deep into the erector spinae muscle fascia. Following confirmation of the correct position of the needle 30 ml 0.25% bupivacaine will be administered for the block.

Drug: Postoperative analgesia management
Intravenous paracetamol 1 gr and a dose of 0,5 mg/kg-1 tramadol intravenously will be performed on all patients 30 min before the end of the surgery for postoperative analgesia. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. A patient-controlled device prepared with 5 mg/ ml tramadol will be attached to all patients with a protocol including 10 mg bolus without infusion dose, 10 min lockout time, and 4-hour limit. If the VAS score will be ≥ 4, 0,5 mg/kg-1 meperidine IV will be administered.

Active Comparator: Group ESPB = erector spina plan block

FIC block will be performed in the supine position. The linear probe is placed transversely to identify the femoral artery, iliopsoas muscle, and fascia iliaca at the inguinal crease. The probe will be tilted cranially and caudally until optimal images of the fascia iliaca are obtained. Block needle (50 mm, 22G) will be passed through the iliac fascia via the in-plane method. Once the needle tip will be placed within the interfacial plane and after careful aspiration to rule out intravascular needle placement, 2 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine 30 mL will be injected.

Drug: Postoperative analgesia management
Intravenous paracetamol 1 gr and a dose of 0,5 mg/kg-1 tramadol intravenously will be performed on all patients 30 min before the end of the surgery for postoperative analgesia. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. A patient-controlled device prepared with 5 mg/ ml tramadol will be attached to all patients with a protocol including 10 mg bolus without infusion dose, 10 min lockout time, and 4-hour limit. If the VAS score will be ≥ 4, 0,5 mg/kg-1 meperidine IV will be administered.

Outcome Measures

Primary Outcome Measures

  1. Opioid consumption [Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.]

    The tramadol consumption on PCA device will be evaluated

Secondary Outcome Measures

  1. Postoperative pain score [Postoperative 1, 2, 4, 8, 16 and 24 hours]

    Postoperative pain assessment will be performed using the Numerical Rating Scale (0 = no pain, 10 = the most severe pain felt)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with ASA classification I-III

  • Aged 18-80 years

  • Who will be scheduled for total hip prosthesis surgery under spinal anesthesia

Exclusion Criteria:
  • Patients who have a history of bleeding diathesis

  • Take anticoagulant therapy

  • History of chronic pain before surgery

  • Known local anesthetics and opioid allergy

  • Pregnancy or lactation

  • Infection at the site of block

  • Patients who do not accept the procedure

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mursel Ekinci Bursa Turkey

Sponsors and Collaborators

  • Mursel Ekinci

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mursel Ekinci, Principal Investigator, Bursa City Hospital
ClinicalTrials.gov Identifier:
NCT05621161
Other Study ID Numbers:
  • BursaCityH1
First Posted:
Nov 17, 2022
Last Update Posted:
Dec 1, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mursel Ekinci, Principal Investigator, Bursa City Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2022