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

Postoperative Pain Clinical Trial

— ESPB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04943549
• Other study ID #: 5-5-2021
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: June 2021
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 15, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bupivacain
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.

Locations

Country	Name	City	State
Egypt	Banha Faculity of Medicine	Banha	Elqalyoubea

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

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