Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Single Level Lumbar Spine Fixation

Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Patients Undergoing Single Level Lumbar Spine Fixation: A Non-inferiority Randomized Clinical Trial

The analgesic efficacy of different volumes in ESPB patients undergoing single-level lumbar spine fixation

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Bupivacaine 0.25% Injectable Solution

Detailed Description

The erector spinae plane block (ESPB) its an interfacial plane block for an effective treatment for thoracic neuropathic pain. Currently, compared to the use of opioids, the ESPB has fewer side effects and is safe for patients of all ages having abdominal and thoracic operations .

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 33516
      • Kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18-65 years.
2. Both genders.
3. American Society of Anesthesiologists' (ASA) physical status I or II.
4. Undergoing single level lumbar spine fixation.

Exclusion Criteria:

1. Patient refusal.
2. Pregnant females.
3. Renal, lung, heart, or liver disorders.
4. Communication difficulties which might prevent a reliable postoperative assessment.
5. Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, known allergy to local anesthetics).
6. BMI more than 30 kg/m2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erector 10; Received 10ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side	Drug: Bupivacaine 0.25% Injectable Solution; Bilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25%
Experimental: Erector 15; Received 15ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side	Drug: Bupivacaine 0.25% Injectable Solution; Bilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25%
Experimental: Erector 20; Received 20ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side	Drug: Bupivacaine 0.25% Injectable Solution; Bilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption	Patients were allowed to receive incremental doses of morphine 3mg intravenously if numerical rating scale pain score will be ≥ then the total amount of morphine will be recorded	First 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical rating scale	Postoperative pain using numerical rating scale (NRS) will be measured at post-anesthesia care unit, from 0 to 10, with 0 representing no pain and 10 representing maximum intolerable pain	Up to 48 hours postoperatively
Time to the first rescue analgesic	If numerical rating scale >4 was observed, rescue analgesia (morphine 3 mg IV) was administered	Up to 24 hours postoperatively
Postoperative complications	postoperative nausea and vomiting (PONV), hypotension (mean arterial pressure < 20% of baseline readings and was managed by ephedrine 5 mg IV and/or normal saline IVI), bradycardia (heart rate < 60 beats/min and was managed by atropine 0.6 mg IV).	Up to 24 hours postoperatively
5-point scale	The degree of patient satisfaction was assessed on a 5-point scale: (0= extremely dissatisfied, 1= unsatisfied, 2= neither satisfied nor unsatisfied, 3= satisfied), and 4= extremely satisfied).	Up to 24 hours postoperative

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): September 20, 2023
• Study Completion (Actual): September 20, 2023

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 28, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: MKSU 50- 1 - 10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: The data will be available after the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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.: Yes