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

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Bupivacain

• Registration Number: NCT04943549
• Lead Sponsor: Benha University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-01
• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-06-29
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-15
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (A)	Bupivacain	History of addiction.
Group (N)	Bupivacain	No history of addiction to any drug.

Primary Outcome Measures

Name	Time	Method
The quality of recovery score (QoR-15) at 24th hour	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 Outcome Measures

Name	Time	Method
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 hours	First-time morphine use(in hours).
First time to ambulation after surgery.	In 24 hours	First 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.

Trial Locations

Locations (1)

Banha Faculity of Medicine; 🇪🇬 Banha, Elqalyoubea, Egypt