Erector Spinae Plane Block

NCT04118101 | Completed Phase 2 DMC

• 1 other identifier: TBRI 2
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Erector spinae plane block (ESPB) is a relatively new plane block that was first described by Forero et al. in 2016, to manage persistent neuropathic pain following malunited rib fracture and persistent post-thoracotomy neuropathic pain.It's a relatively simple, ultrasound guided block in which the local anesthetic drugs are injected in the plane between the erector spinae muscle and the vertebral transverse process.This allows the injected local anesthetics to block the ventral and dorsal rami of the spinal nerves in the paravertebral area. The literature reveals successful case reports denoting the use of ESPB for pain control in cases of acute kidney transplant,percutaneous nephrolithomy, abdominal surgeries including laparoscopic and open nephrectomy, and nephrectomy in the pediatric population. The aim of this prospective randomized controlled study is to investigate the efficacy of ESPB for pain control in adult patients undergoing open renal surgery through a flank incision with respect to pain scores, postoperative analgesia consumption and patient satisfaction.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Time to first rescue analgesia

  Rescue analgesia with intravenous pethidine (25 mg) will be prescribed if the patient's resting NRS score is more than three or on patient demand. Additional intravenous doses of 25 mg of pethidine will be given if needed to achieve a score below 4. The second rescue analgesic plan will be intravenous ketorolac 30 mg diluted in 100 ml normal saline and administered slowly, if NRS remained persistently \>3 after 15 min of the first rescue analgesic administration.

  30-45 minutes.

Secondary Outcomes (2)

• Postoperative analgesic consumption

  over the first 24 hours post operatively.

• Patient satisfaction

  over first 24 hours post operatively.

Study Arms (2)

ESPB group

ACTIVE COMPARATOR

A total of 25 ml bupivacaine 0.5% willbe injected into the ESP.

Drug: ESPB block

Control group

PLACEBO COMPARATOR

The ESPB will not be performed.

Other: control

Interventions

ESPB block DRUG

A total of 25 ml bupivacaine 0.5% will be injected into the ESP.

ESPB group

control OTHER

no ESPB will be given.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient is able to provide a written informed consent.
• ASA I-II.
• Patient is scheduled to perform an elective open renal surgery through a flank incision.

You may not qualify if:

• ASA III-IV
• Pregnancy.
• Patient is allergic to bupivacaine local anesthetic.
• Impaired coagulation (Platelet count\< 150,000 cells/mcl and/or INR ≥ 1.4).
• Infection at site of injection.
• Prior same side flank surgery.

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz research institute

Cairo, 02, Egypt

Location

Related Publications (1)

• 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.

  PMID: 27501016 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

• Moshira S Mohamed, MD

  Theodor Bilharz Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded control study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia and Intensive care clinical researcher

Model Details: After skin sterilization and draping, a high-frequency linear array ultrasound probe will be placed on the back in a transversly to identify the tip of the T7 transverse process. The tip of the transverse process will be centered on the ultrasound screen and the probe will be rotated into a longitudinally to produce a para-sagittal view, in which the following layers will be visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius and erector spinae muscle. An echogenic 22-G block needle will be inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T7 transverse process. Correct location oft he needle tip in the fascial plane deep to erector spinae muscle will confirmed by injecting 0.5-1 ml normal saline and seeing the fluid lifting the erector spinae muscle off the transverse process without distending the muscle.

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 8, 2019
• Study Start: October 25, 2019
• Primary Completion: December 10, 2020
• Study Completion: February 15, 2021
• Last Updated: April 2, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year

Locations

EG (1)