Erector Spinae Plane Block in Spine Surgeries for Postoperative Pain

NCT06970704 | Completed

• 1 other identifier: FMASU MS 681/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective single-blind randomized controlled study on 50 patients between 18 and 65 years, both sexes, with ASA I-II and undergoing elective lumbar spine surgical procedures. They were equally divided into two groups: Group Erector Spinae Plane Block (ESPB) (Study): (number = 25) received Erector Spinae Plane Block (20 ml bupivacaine 0.25%) combined with general anesthesia. Group General Anesthesia (GA) (Control): (number = 25) received conventional general anesthesia.

Conditions

Spine Fusion; Spine Metastases; Postoperative Pain

Outcome Measures

Primary Outcomes (4)

• Postoperative pain severity

  Using Pain Numeric Rating Scale Scores

  Postoperatively Day 1

• Time to the first postoperative rescue analgesic

  Time to first use of morphine

  Postoperatively Day 1

• Fentanyl consumption.

  Intraoperative fentanyl consumption

  During Intraoperative period

• Isoflurane consumption.

  Intraoperative fentanyl and isoflurane consumption.

  During Intraoperative period

Secondary Outcomes (3)

• Changes in mean arterial pressure

  Immediately before the operation till Postoperatively Day 1

• Changes in heart rate

  Immediately before the operation till Postoperatively Day 1

• Postoperative nausea and vomiting

  Postoperatively Day 1

Study Arms (2)

Group Erector Spinae Plane Block (ESPB) (Study)

ACTIVE COMPARATOR

Patients in this group will receive Erector Spinae Plane Block (20 ml bupivacaine 0.25%) combined with general anesthesia

Other: Erector Spinae Plane Block using 0.25 % bupivacaine

Group General Anesthesia (GA) (Control)

ACTIVE COMPARATOR

Patients in this group will receive conventional general anesthesia

Other: Erector Spinae Plane Block using 0.25 % bupivacaine

Interventions

Erector Spinae Plane Block using 0.25 % bupivacaine OTHER

After induction of anesthesia and prone positioning and before surgery, Erector Spinae Plane Block was performed bilaterally using a low-frequency curved ultrasound transducer placed in a longitudinal orientation 3 cm lateral to the spinous process one vertebral level above a predetermined marked surgical incision. An 8-cm 22-gauge block needle was inserted in a cephalad to caudad direction until the tip lay in the interfascial plane below the erector spinae muscle, the block was performed by injection of 20 ml of 0.25% bupivacaine. Fentanyl 1 µg/kg as a rescue analgesia was given based on hemodynamic parameters.

Group Erector Spinae Plane Block (ESPB) (Study); Group General Anesthesia (GA) (Control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged from 18 and 65 years, both sexes
• The American Society of Anesthesiology (ASA) physical status I-II
• Scheduled for elective lumbar spine surgical procedures

You may not qualify if:

• Coagulation disorders
• BMI \> 30 or \< 18 kg/m2
• Patients with surgical site infection
• Known sensitivity or contraindication to local anesthetics
• History of psychological disorders
• Patients with unstable spine integrity like fractures or scoliosis
• Hypertensive, cardiac, and diabetic patients,
• Known alcohol or substance abuse within the last 6 months and Daily opioid intake

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11566, Egypt

Location

Related Publications (8)

• Prabhakar NK, Chadwick AL, Nwaneshiudu C, Aggarwal A, Salmasi V, Lii TR, Hah JM. Management of Postoperative Pain in Patients Following Spine Surgery: A Narrative Review. Int J Gen Med. 2022 May 2;15:4535-4549. doi: 10.2147/IJGM.S292698. eCollection 2022.

  PMID: 35528286 BACKGROUND

• Ye Y, Bi Y, Ma J, Liu B. Thoracolumbar interfascial plane block for postoperative analgesia in spine surgery: A systematic review and meta-analysis. PLoS One. 2021 May 21;16(5):e0251980. doi: 10.1371/journal.pone.0251980. eCollection 2021.

  PMID: 34019598 BACKGROUND

• Hyland SJ, Brockhaus KK, Vincent WR, Spence NZ, Lucki MM, Howkins MJ, Cleary RK. Perioperative Pain Management and Opioid Stewardship: A Practical Guide. Healthcare (Basel). 2021 Mar 16;9(3):333. doi: 10.3390/healthcare9030333.

  PMID: 33809571 BACKGROUND

• Jin Y, Zhao S, Cai J, Blessing M, Zhao X, Tan H, Li J. Erector Spinae Plane Block for Perioperative Pain Control and Short-term Outcomes in Lumbar Laminoplasty: A Randomized Clinical Trial. J Pain Res. 2021 Sep 3;14:2717-2727. doi: 10.2147/JPR.S321514. eCollection 2021.

  PMID: 34512011 BACKGROUND

• Rasheed AM, Amirah MF, Abdallah M, P J P, Issa M, Alharthy A. Ramsay Sedation Scale and Richmond Agitation Sedation Scale: A Cross-sectional Study. Dimens Crit Care Nurs. 2019 Mar/Apr;38(2):90-95. doi: 10.1097/DCC.0000000000000346.

  PMID: 30702478 BACKGROUND

• Nashibi M, Sezari P, Safari F, Teymourian H, Asgari S, Mottaghi K. The effect of erector spinae plane block on the use of anesthetic medications in lumbar spine surgery. Agri. 2023 Oct;35(4):228-235. doi: 10.14744/agri.2022.48992.

  PMID: 37886866 BACKGROUND

• Elewa AM, Faisal M, Sjoberg F, Abuelnaga ME. Comparison between erector spinae plane block and paravertebral block regarding postoperative analgesic consumption following breast surgery: a randomized controlled study. BMC Anesthesiol. 2022 Jun 18;22(1):189. doi: 10.1186/s12871-022-01724-3.

  PMID: 35717148 BACKGROUND

• Zhang Q, Wu Y, Ren F, Zhang X, Feng Y. Bilateral ultrasound-guided erector spinae plane block in patients undergoing lumbar spinal fusion: A randomized controlled trial. J Clin Anesth. 2021 Feb;68:110090. doi: 10.1016/j.jclinane.2020.110090. Epub 2020 Oct 20.

  PMID: 33096517 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: May 14, 2025
• Study Start: December 31, 2023
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: May 22, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)