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

Sponsor

Benha University (Other)

Overall Status

Completed

CT.gov ID

NCT04943549

Collaborator

(none)

Enrollment

Location

Arms

6.5

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Bupivacain	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

double blinded

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Nov 1, 2021

Actual Study Completion Date :

Dec 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group (A) History of addiction.	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.
Placebo Comparator: Group (N) No history of addiction to any drug.	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.

Arm

Intervention/Treatment

Active Comparator: Group (A)

History of addiction.

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.

Placebo Comparator: Group (N)

No history of addiction to any drug.

Drug: Bupivacain

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banha Faculity of Medicine	Banha	Elqalyoubea	Egypt	13511

Sponsors and Collaborators

Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fatma Ahmed Abdel Fatah, Lecturer, Benha University

ClinicalTrials.gov Identifier:

NCT04943549

Other Study ID Numbers:

5-5-2021

First Posted:

Jun 29, 2021

Last Update Posted:

Jan 11, 2022

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fatma Ahmed Abdel Fatah, Lecturer, Benha University

Lumber surgery

Postoperative analgesia

Erector spinae pain block

Additional relevant MeSH terms:

Pain, Postoperative

Bupivacaine

Study Results

No Results Posted as of Jan 11, 2022