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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacain
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Lumber surgery, Postoperative analgesia, Erector spinae pain block

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Banha Faculity of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group (A)

Group (N)

Arm Description

History of addiction.

No history of addiction to any drug.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Postoperative pain.
Postoperative pain assessed by VAS which scales from zero (no pain) to ten (unbearable pain). .
Intraoperative fentanyl dosage.
Intraoperative fentanyl dosage (μg)
First-time morphine use.
First-time morphine use(in hours).
First time to ambulation after surgery.
First time to ambulation after surgery(in hours).
Length of hospital stay.
It is the time of postoperative patient's stay in hospital till discharge.

Full Information

First Posted
June 8, 2021
Last Updated
January 6, 2022
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT04943549
Brief Title
Erector Spinae Plane Block Impact on Quality of Recovery After Lumbar Spinal Decompression
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Lumber surgery, Postoperative analgesia, Erector spinae pain block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double blinded
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (A)
Arm Type
Active Comparator
Arm Description
History of addiction.
Arm Title
Group (N)
Arm Type
Placebo Comparator
Arm Description
No history of addiction to any drug.
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Intervention Description
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 Outcome Measure Information:
Title
The quality of recovery score (QoR-15) at 24th hour
Description
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).
Time Frame
at 24th hour
Secondary Outcome Measure Information:
Title
Postoperative pain.
Description
Postoperative pain assessed by VAS which scales from zero (no pain) to ten (unbearable pain). .
Time Frame
At half an hour, 2, 4, 8, 12, 24 hours.
Title
Intraoperative fentanyl dosage.
Description
Intraoperative fentanyl dosage (μg)
Time Frame
From the start of operation till its end up to 3 hours.
Title
First-time morphine use.
Description
First-time morphine use(in hours).
Time Frame
In 24 hours
Title
First time to ambulation after surgery.
Description
First time to ambulation after surgery(in hours).
Time Frame
In 24 hours
Title
Length of hospital stay.
Description
It is the time of postoperative patient's stay in hospital till discharge.
Time Frame
up to 3 days.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Banha Faculity of Medicine
City
Banha
State/Province
Elqalyoubea
ZIP/Postal Code
13511
Country
Egypt

12. IPD Sharing Statement

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

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