AnalgesiaPhase 3NCT05448469
Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia in Patients Undergoing Open Splenectomy
A Phase 3 study testing ultrasound guided erector spinae plane block, ultrasound guided paravertebral block and conventional analgesia in people with Analgesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
There are very few randomized controlled trials in open splenectomy surgery, which compare paravertebral block with ESP block. The purpose of this randomized controlled trial is to compare the efficacy of ultrasound-guided paravertebral block with ESP block for perioperative analgesia in open splenectomy . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia
- What is being tested?
- ultrasound guided erector spinae plane block, ultrasound guided paravertebral block and conventional analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2022to 10 Dec 2022
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who will be scheduled for indicated open splenectomy surgery in the supine position via left subcostal ,midline or letf subcostal with midline extention incisions
- physical status American Society of Anesthesiologists (ASA) II or III.
Who cannot join
- Patients who refuse to participate
- patients with body mass index (BMI) >35 kg/m2
- infection at the site of injection
- coagulopathy, severe thrombocytopenia <50×103
- spine deformity
- history of opioid dependence
Show all 10Show fewer
- polytrauma patients with dorsal spine fracture
- urgent abdominal exploration for splenectomy in heamodynamically unstable patients
- history of allergy to opioids or local anesthetics
- history of allergy to opioids, or local anaesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia, a Randomized Double Blinded Controlled Trial
There are very few randomized controlled trials in open splenectomy surgery, which compare paravertebral block with ESP block. The purpose of this randomized controlled trial is to compare the efficacy of ultrasound-guided paravertebral block with ESP block for perioperative analgesia in open splenectomy .
- Conditions
- Analgesia
- Being tested
- ultrasound guided erector spinae plane block, ultrasound guided paravertebral block, conventional analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided erector spinae plane blockProcedure or surgery
patients will receive combined general anesthesia and ultrasound guided erector spinae plane block with 20 ml of bupivacaine 0.2 % at T9 level bilaterally.
ultrasound guided paravertebral blockProcedure or surgery
patients will receive combined general anesthesia and ultrasound guided paravertebral block with 7 ml of bupivacaine 0.2 % at T8 and T10 bilaterally.
conventional analgesiaDrug
patients will receive combined general anesthesia and conventional analgesia
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia+ bilateral US guided erector spinae plane block | Active comparator | General anesthesia plus ultrasound guided erector spinae plane block with 20 ml bupivacaine 0.2% at T9 Receives: Procedure: ultrasound guided erector spinae plane block |
| general anesthesia+ bilateral US guided paravertebral block | Active comparator | General anesthesia plus bilateral US guided paravertebral block with 7 ml bupivacaine 0.2% at T8 and T10 Receives: Procedure: ultrasound guided paravertebral block |
| general anesthesia | Active comparator | general anesthesia plus conventional analgesia Receives: Drug: conventional analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
First time to analgesic requirement
all patients received an IV -PCA system (Accufuser M8P, 60 mL; Woo Young Meditech Co, S.Korea). PCA was prepared with 60 mL of isotonic saline containing 60 mg morphine, and the selected system was adjusted to infuse a 1 mL bolus dose with a lockout interval of 15 minutes while the basal flow rate was switched off. Breakthrough pain was managed with 2mg morphine.
Measured: 1st 24 hour
Secondary outcomes (2)
total analgesic consumption
The total dose of rescue analgesics(morphine) required in 24 hours will be recorded.
Measured: 1st 24 hour
Numerical rating scale (NRS)
All patients will be monitored in the postoperative period for pain by the NRS score at rest and movement at immediate postoperative (0 min), 30 min, 1, 2, 6,12, and 24 hours.
Measured: 1st 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start10 Jul 2022
- Primary completion10 Dec 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448469
- Sponsor's protocol ID
- R 97/2022
- Status last verified
- Dec 2022
- First submitted
- 2 Jul 2022
- Last updated
- 23 Dec 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 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia, a Randomized Double Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT05448469
- Acronym / sponsor ID
- R 97/2022
- Conditions
- Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 7 Jul 2022 (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.
There are very few randomized controlled trials in open splenectomy surgery, which compare paravertebral block with ESP block. The purpose of this randomized controlled trial is to compare the efficacy of ultrasound-guided paravertebral block with ESP block for perioperative analgesia in open splenectomy .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| general anesthesia+ bilateral US guided erector spinae plane block | Active comparator | Procedure: ultrasound guided erector spinae plane blockGeneral anesthesia plus ultrasound guided erector spinae plane block with 20 ml bupivacaine 0.2% at T9 |
| general anesthesia+ bilateral US guided paravertebral block | Active comparator | Procedure: ultrasound guided paravertebral blockGeneral anesthesia plus bilateral US guided paravertebral block with 7 ml bupivacaine 0.2% at T8 and T10 |
| general anesthesia | Active comparator | Drug: conventional analgesiageneral anesthesia plus conventional analgesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who will be scheduled for indicated open splenectomy surgery in the supine position via left subcostal ,midline or letf subcostal with midline extention incisions
- physical status American Society of Anesthesiologists (ASA) II or III.
Key exclusion criteria (10 listed)
- Patients who refuse to participate
- patients with body mass index (BMI) >35 kg/m2
- infection at the site of injection
- coagulopathy, severe thrombocytopenia <50×103
- spine deformity
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 |
|---|---|---|
| ultrasound guided erector spinae plane blockpatients will receive combined general anesthesia and ultrasound guided erector spinae plane block with 20 ml of bupivacaine 0.2 % at T9 level bilaterally. | Procedure or surgery | general anesthesia+ bilateral US guided erector spinae plane block |
| ultrasound guided paravertebral blockpatients will receive combined general anesthesia and ultrasound guided paravertebral block with 7 ml of bupivacaine 0.2 % at T8 and T10 bilaterally. | Procedure or surgery | general anesthesia+ bilateral US guided paravertebral block |
| conventional analgesiapatients will receive combined general anesthesia and conventional analgesia | Drug | general anesthesia |
Primary outcome
First time to analgesic requirement
Time frame: 1st 24 hour
all patients received an IV -PCA system (Accufuser M8P, 60 mL; Woo Young Meditech Co, S.Korea). PCA was prepared with 60 mL of isotonic saline containing 60 mg morphine, and the selected system was adjusted to infuse a 1 mL bolus dose with a lockout interval of 15 minutes while the basal flow rate was switched off. Breakthrough pain was managed with 2mg morphine.
2 secondary outcomes
total analgesic consumption
Time frame: 1st 24 hour
Numerical rating scale (NRS)
Time frame: 1st 24 hour
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 23 Dec 2022.
Related trials for Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
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 3 study testing ultrasound guided erector spinae plane block, ultrasound guided paravertebral block and conventional analgesia in people with Analgesia, run by Ain Shams 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 2 inclusion and 10 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 23 Dec 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
First time to analgesic requirement (time frame: 1st 24 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 23 Dec 2022.