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NCT Number: NCT03960528

The Effect of Erector Spinae Plane Block Performed Under Direct Vision on Postoperative Pain in Spine Surgery

Spine surgery is typically associated with severe postoperative pain. Although the number of spine surgeries has increased day by day, postoperative pain management have been limited. The recently described erector spinae plane block (ESPB) is obtained by applying the local anesthetic drug between the fascia of the erector spinae muscles and the transverse process of the vertebrae. Anatomical and radiological investigations in fresh cadavers suggest that the potential place of influence of ESPB is dorsal and ventral spinal nerve roots. A small number of publications showing the analgesic efficacy of ESP in spinal surgery have been reported in the literature. The erector spinae muscles are easily identified during spine surgery, and erector spinae plane blocks can be performed under direct vision rather than via ultrasound guidance or simply using anatomical landmarks. Therefore, the investigators aim to observe the efficacy of the under direct vision erector spinae plane block on pain scores after spinal surgery.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf University

Istanbul, 34093, Turkey (Türkiye)

About this study

Approval from the university local ethics committee will be obtained. Participans will be informed about the potential benefits and complications after the study protocol has been fully and thoroughly explained. After premedication with 0.03 mg / kg iv midazolam, participans will be noninvasively monitored by taking into the operating room (heart rate, blood pressure, pulse oximetry). Anesthesia induction will delivered with fentanyl 1mcg / kg, propofol 2 mg / kg and rocuronium 0.6 mg / kg. The maintenance of anesthesia will be achieved by infusion of sevoflurane 2-3% in 50% O2/50% medical air and remifentanil infusion of 0.1-0.5 mcg / kg / min. Thirty minutes before end of the surgery, all patients were intravenously administered 1 mg/kg tramadol HCl and 1gr paracetamol.

Under direct vision ESPB technique: Erector spinae muscles and transverse processes will be identified by the surgeon. At the end of the surgery 20 ml bupivacaine 0.25%/lidocaine 1% mixture will be injected to the between of the erector spinae muscles and transverse processes bilaterally. In the sham comparator group, 20 ml of isotonic saline will be administered bilaterally by the surgeon as described above.

After the surgery, 1 g paracetamol was intravenously administered once every 8 h. A patient-controlled analgesia (PCA) device, which was prepared using morphine, was attached to the patients and was programmed to administer concentration 0.5mg / ml ( 2cc bolus 8 min lock time 2cc/h infusion). This administration continued for 24 h. Postoperative pain was assessed using visuel analog scale (VAS) (VAS 0 = no pain, VAS 10 = most severe pain ). Duration at postanesthesia care unit (PACU) was recorded right from 0 h. VAS scores at 0, 1, 6, 12 and 24 h were recorded. Postoperative nausea and vomiting (PONV) was evaluated using a numeric ranking scale (0 = no PONV, 1 = mild nausea, 2 = severe nausea or vomiting once attack, and 3 = vomiting more than once attack). If PONV score was >2, the antiemetic metoclopramide Hcl 10mg was intravenously administered.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 20-75 years
  • ASA 1-2-3
  • Patients scheduled for elective surgery

Exclusion criteria

  • Patients with previous neurological disease symptoms (TIA, syncope, dementia, etc.)
  • Allergy to drugs
  • Major cardiac disease
  • Renal failure
  • Psychiatric disease
  • Patients who refuse to participate in the study
  • Chronic back and lower back pain
  • Body mass index <18.5 and >40

Treatment and study plan

Erector Spinae Plane Block

Procedure

Bilateral 20 ml Bupivacaine 0.25% + lidocaine 1% injected between erector spinae muscles and transverse process under direct vision.

Other names: ESP block

Control Group

Procedure

20 ml NaCl 0,9% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side.

Other names: Sham comparator

Primary outcomes

  1. Total morphine consumption

    Time frame: 1 day

    The total amount of morphine given by patient controlled analgesia in 24 hours will be recorded

Secondary outcomes

  1. Pain intensity score

    Time frame: 1 day

    Changes in Numeric Rating Scale (NRS) will be recorded at postoperative 1, 6, 12, 24 hour. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient pain. Each item is scored 0-10( 0:no pain 10: pain as bad as can be )

  2. Postoperative nausea and vomiting

    Time frame: 1 day

    Changes in Numeric Rank Score will be recorded at postoperative 1, 6, 12, 24 hour. Numeric rank score 0-3(0: no nausea and vomiting; 1:have nausea, no vomiting; 2:once vomiting attack; 3: have two or more vomiting attacks)

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Investigation of Erector Spinae Plane Block Effect in Spine Surgery

Acronym: ESPOUSES

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 23, 2019
Registry last updated
Sep 8, 2021

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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