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Erector Spinae Plane Block Impact on Quality of Recovery After Lumbar Spinal Decompression

Erector Spinae Plane Block Impact on Quality of Recovery After Lumbar Spinal Decompression Surgery; a Comparative Study Between Addicts and Non-addicts

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04943549
Acronym
ESPB
Enrollment
60
Registered
2021-06-29
Start date
2021-06-01
Completion date
2021-12-15
Last updated
2022-01-11

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

Conditions

Postoperative Pain

Keywords

Lumber surgery, Postoperative analgesia, Erector spinae pain block

Brief summary

Erector spinae plane block (ESPB) as a new trunk fascia block technique was proposed in 2016. ESPB has aroused the interest of many nerve block experts. The benefits of ESPB are not yet demonstrated. The specific mechanism is still controversial. Some believe that ESPB can block the posterior root of the spinal nerve and produce part of the para-spinal block effect with the diffusion of the drug solution. The present study will carried out to compare the performance of the erector spinae plane block combined with general anesthesia in addicts versus non addicts' patients regarding the local analgesic effect, recovery after surgery and side effects.

Interventions

DRUGBupivacain

Patients will be placed in left lateral position. A low-frequency curved array ultrasound transducer will be used. The ultrasound transducer will be placed in a longitudinal orientation 2-3 cm lateral to the midline to identify the hyperechoic line of the transverse process. After identification of muscles superficial to the transverse process and local infiltration of anesthesia into the superficial tissues, a block needle will be inserted in a craniocaudal direction until contact will be achieved with the transverse process where the tip will lay in the interfascial plane below the erector spinae muscle. A small bolus of local anaesthetic should be given through the block needle; the erector spinae muscle should be visualized, separating from the transverse process. A total of 20 mL bupivacaine 0.25% will be injected into the interfacial plane deep to the erector spinae muscle bilaterally. Forty minutes after the ESPB, the cutaneous sensory block will be assessed.

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

double blinded

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. Male gender. 2. Age range of 18-60 years. 3. Scheduled for open lumbar decompression surgery. 4. A minimum of 1-year experience of drug consumption or having drug withdrawal symptoms when stopping for inclusion in the drug addicts group(according to the patient's statement and rapid opiate urine test).

Exclusion criteria

1. Hepatic or renal insufficiency. 2. Preoperative cognitive dysfunction or communication disorder. 3. Allergy to amide-type local anaesthetics. 4. Back puncture site infection. 5. Coagulation disorders. 6. Emergency surgery.

Design outcomes

Primary

MeasureTime frameDescription
The quality of recovery score (QoR-15) at 24th hourat 24th hourThis questionnaire covers a total of 15 questions under five clinical dimensions of health; physical comfort (five-item), emotional status (four-item), psychological support (two-item), physical independence (two-item) and pain (two-item). a numerical rating scale of 11 point for each question leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).

Secondary

MeasureTime frameDescription
Postoperative pain.At half an hour, 2, 4, 8, 12, 24 hours.Postoperative pain assessed by VAS which scales from zero (no pain) to ten (unbearable pain). .
Intraoperative fentanyl dosage.From the start of operation till its end up to 3 hours.Intraoperative fentanyl dosage (μg)
First-time morphine use.In 24 hoursFirst-time morphine use(in hours).
First time to ambulation after surgery.In 24 hoursFirst time to ambulation after surgery(in hours).
Length of hospital stay.up to 3 days.It is the time of postoperative patient's stay in hospital till discharge.

Countries

Egypt

Outcome results

None listed

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