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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05892887
Enrollment
60
Registered
2023-06-07
Start date
2023-06-01
Completion date
2023-09-20
Last updated
2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

Brief summary

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

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 .

Interventions

Bilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25%

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Total morphine consumptionFirst 24 hours postoperativelyPatients 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

Secondary

MeasureTime frameDescription
Numerical rating scaleUp to 48 hours postoperativelyPostoperative 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
Time to the first rescue analgesicUp to 24 hours postoperativelyIf numerical rating scale \>4 was observed, rescue analgesia (morphine 3 mg IV) was administered
Postoperative complicationsUp to 24 hours postoperativelypostoperative 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).
5-point scaleUp to 24 hours postoperativeThe 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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026