Postoperative PainPhase 4ESPBNCT04943549
Erector Spinae Plane Block Impact on Quality of Recovery After Lumbar Spinal Decompression
A Phase 4 study testing Bupivacain in people with Postoperative Pain, run by Benha University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 15 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Hepatic or renal insufficiency.
- Preoperative cognitive dysfunction or communication disorder.
- Allergy to amide-type local anaesthetics.
- Back puncture site infection.
- Coagulation disorders.
- Emergency surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block Impact on Quality of Recovery After Lumbar Spinal Decompression Surgery; a Comparative Study Between Addicts and Non-addicts
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
- Being tested
- Bupivacain
- Keywords
- Lumber surgery, Postoperative analgesia, Erector spinae pain block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Active comparator | History of addiction. Receives: Drug: Bupivacain |
| Group (N) | Placebo comparator | No history of addiction to any drug. Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 24th hour
Secondary outcomes (5)
Postoperative pain.
Postoperative pain assessed by VAS which scales from zero (no pain) to ten (unbearable pain).
.
Measured: At half an hour, 2, 4, 8, 12, 24 hours.
Intraoperative fentanyl dosage.
Intraoperative fentanyl dosage (μg)
Measured: From the start of operation till its end up to 3 hours.
First-time morphine use.
First-time morphine use(in hours).
Measured: In 24 hours
First time to ambulation after surgery.
First time to ambulation after surgery(in hours).
Measured: In 24 hours
Length of hospital stay.
It is the time of postoperative patient's stay in hospital till discharge.
Measured: up to 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Jun 2021
- Primary completion1 Nov 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ahmed Abdel Fatah, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943549
- Sponsor's protocol ID
- 5-5-2021
- Acronym
- ESPB
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Impact on Quality of Recovery After Lumbar Spinal Decompression Surgery; a Comparative Study Between Addicts and Non-addicts
- ClinicalTrials.gov ID
- NCT04943549
- Acronym / sponsor ID
- ESPB / 5-5-2021
- Conditions
- Postoperative Pain
- Keywords
- Lumber surgery, Postoperative analgesia, Erector spinae pain block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Active comparator | Drug: BupivacainHistory of addiction. |
| Group (N) | Placebo comparator | Drug: BupivacainNo history of addiction to any drug. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- Hepatic or renal insufficiency.
- Preoperative cognitive dysfunction or communication disorder.
- Allergy to amide-type local anaesthetics.
- Back puncture site infection.
- Coagulation disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacainPatients 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. | Drug | Group (A), Group (N) |
Primary outcome
The quality of recovery score (QoR-15) at 24th hour
Time frame: 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).
5 secondary outcomes
Postoperative pain.
Time frame: At half an hour, 2, 4, 8, 12, 24 hours.
Intraoperative fentanyl dosage.
Time frame: From the start of operation till its end up to 3 hours.
First-time morphine use.
Time frame: In 24 hours
First time to ambulation after surgery.
Time frame: In 24 hours
Length of hospital stay.
Time frame: up to 3 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacain in people with Postoperative Pain, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of recovery score (QoR-15) at 24th hour (time frame: at 24th hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.