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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05892887
• Other study ID #: MKSU 50- 1 - 10
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2023
• Est. completion date: September 20, 2023

Study information

• Verified date: October 2023
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Bupivacaine 0.25% Injectable Solution
Bilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25%

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University	Kafr Ash Shaykh	Kafrelsheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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