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

• ClinicalTrials.gov Identifier: NCT03960528
• Recruitment Status: Completed
• First Posted: May 23, 2019
• Last Update Posted: September 8, 2021
• Sponsor: Bezmialem Vakif University
• Information provided by (Responsible Party): Bezmialem Vakif University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Acute Pain	Procedure: Erector spinae plane block; Procedure: Control group	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Investigation of Erector Spinae Plane Block Effect in Spine Surgery
• Actual Study Start Date: April 18, 2019
• Actual Primary Completion Date: January 10, 2020
• Actual Study Completion Date: February 10, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Under direct vision erector spinae plane block; 20 ml bupivacaine 0,25%+ lidocaine 1% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side. Participants will receive morphine iv PCA in the postanesthesia care unit( 0.5mg / ml 2cc bolus 8 min lock time 2cc/h infusion)	Procedure: Erector spinae plane block; Bilateral 20 ml Bupivacaine 0.25% + lidocaine 1% injected between erector spinae muscles and transverse process under direct vision.; Other Name: ESP block
Sham Comparator: Control group; 20 ml NaCl 0,9% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side. Participants will receive morphine iv PCA in the postanesthesia care unit( 0.5mg / ml 2cc bolus 8 min lock time 2cc/h infusion)	Procedure: Control group; 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 Name: Sham comparator

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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)

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

Turkey

Bezmialem Vakıf University

Istanbul, Turkey, 34093

Sponsors and Collaborators

Bezmialem Vakif University

Investigators

• Principal Investigator: Serdar YEŞİLTAŞ, Instructor; BEZMİALEM VAKIF UNIVERSITY

More Information

• Responsible Party: Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT03960528
• Other Study ID Numbers: S003
• First Posted: May 23, 2019
• Last Update Posted: September 8, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Bezmialem Vakif University:

spine surgery; postoperative pain; perioperative analgesia; postoperative opioid requirement

Additional relevant MeSH terms:

Acute Pain; Pain; Neurologic Manifestations