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Completed

NCT Number: NCT04943549

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Banha Faculity of Medicine

Banhā, Elqalyoubea, 13511, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male gender.
  • Age range of 18-60 years.
  • Scheduled for open lumbar decompression surgery.
  • 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

  • Hepatic or renal insufficiency.
  • Preoperative cognitive dysfunction or communication disorder.
  • Allergy to amide-type local anaesthetics.
  • Back puncture site infection.
  • Coagulation disorders.
  • Emergency surgery.

Treatment and study plan

Bupivacain

Drug

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.

Primary outcomes

  1. The quality of recovery score (QoR-15) at 24th hour

    Time frame: at 24th hour

    This 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 outcomes

  1. Postoperative pain.

    Time frame: 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).

    .

  2. Intraoperative fentanyl dosage.

    Time frame: From the start of operation till its end up to 3 hours.

    Intraoperative fentanyl dosage (μg)

  3. First-time morphine use.

    Time frame: In 24 hours

    First-time morphine use(in hours).

  4. First time to ambulation after surgery.

    Time frame: In 24 hours

    First time to ambulation after surgery(in hours).

  5. Length of hospital stay.

    Time frame: up to 3 days.

    It is the time of postoperative patient's stay in hospital till discharge.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Acronym: ESPB

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 29, 2021
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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