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

Phase 4

Completed

• Conditions: Analgesia
• Interventions: Drug: Bupivacaine 0.25% Injectable Solution

• Registration Number: NCT05892887
• Lead Sponsor: Kafrelsheikh University

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 .

Study Timeline

• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-28
• Study Start: 2023-06-01
• Study First Posted: 2023-06-07
• Primary Completion: 2023-09-20
• Study Completion: 2023-09-20
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-08
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector 15	Bupivacaine 0.25% Injectable Solution	Received 15ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side
Erector 10	Bupivacaine 0.25% Injectable Solution	Received 10ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side
Erector 20	Bupivacaine 0.25% Injectable Solution	Received 20ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	First 24 hours postoperatively	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

Secondary Outcome Measures

Name	Time	Method
Numerical rating scale	Up to 48 hours postoperatively	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
Time to the first rescue analgesic	Up to 24 hours postoperatively	If numerical rating scale \>4 was observed, rescue analgesia (morphine 3 mg IV) was administered
Postoperative complications	Up to 24 hours postoperatively	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).
5-point scale	Up to 24 hours postoperative	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).

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafrelsheikh, Egypt