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

NCT04943549 | Completed Phase 4

• 1 other identifier: 5-5-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Lumber surgery; Postoperative analgesia; Erector spinae pain block

Outcome Measures

Primary Outcomes (1)

• The quality of recovery score (QoR-15) 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).

  at 24th hour

Secondary Outcomes (5)

• Postoperative pain.

  At half an hour, 2, 4, 8, 12, 24 hours.

• Intraoperative fentanyl dosage.

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

• First-time morphine use.

  In 24 hours

• First time to ambulation after surgery.

  In 24 hours

• Length of hospital stay.

  up to 3 days.

Study Arms (2)

Group (A)

ACTIVE COMPARATOR

History of addiction.

Drug: Bupivacain

Group (N)

PLACEBO COMPARATOR

No history of addiction to any drug.

Drug: Bupivacain

Interventions

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.

Group (A); Group (N)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha Faculity of Medicine

Banhā, Elqalyoubea, 13511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 29, 2021
• Study Start: June 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 15, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-06

Locations

EG (1)