Acute PainNCT03379987
Analgesic Efficacy of Paravertebral Morphine
A study testing PVB morphine and PVB bupivacaine in people with Acute Pain, run by Assiut University at 1 site in Egypt.
Trial summary
The investigator will test the analgesic efficacy of paravertebral morphine as an adjuvant to local anesthetics for acute postoperative pain following breast surgery and renal surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- PVB morphine and PVB bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to Aug 2019
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients subjected to mastectomy or renal surgery
Who cannot join
- Patients complaining of coagulopathies
- Patients with vertebral anomalies
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Diab
Asyut, Assuit, 71515
Diab Hetta, MD, +201091090009, diabgetta25@gmail.com
About this study
Official title: Analgesic Efficacy of Paravertebral Morphine for Acute Postoperative Pain: Randomized Multicenter Clinical Trial
The investigator will test the analgesic efficacy of paravertebral morphine as an adjuvant to local anesthetics for acute postoperative pain following breast surgery and renal surgery
- Conditions
- Acute Pain
- Being tested
- PVB morphine, PVB bupivacaine
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVB morphineDrug
The PVB was performed under ultrasonographic guidance in the sitting position. Surgical disinfection of thoracoabdominal paravertebral area was done. A linear high-frequency transducer (10-12 MHz, Sonosite, Bothell, WA, USA) was used. The scanning process (Longitudinal out-of-plane technique) was started at 5-10 cm lateral to the spinous process of thoracic vertebrae to identify the rounded ribs and parietal pleura underneath. The transducer is then moved progressively more medially until the transverse processes are identified as more squared structure deeper to the ribs. A 100 mm needle was inserted out-of-plane to contact the transverse process of thoracic vertebra and then, walked off above the transverse process 1-1.5 cm deeper searching for loss of resistance injecting 10 ml of 0.25% bupivacaine + 3 mg morphine for group PVB morphine in incremental doses of 3 ml.
PVB bupivacaineDrug
the same steps mentioned in group PVB morphine but the solution used for paravertebral block contain bupivacaine only 10 ml of 0.25% bupivacaine injected in in incremental doses of 3 ml.
| Study group | Role | What they receive |
|---|---|---|
| PVB morphine | Experimental | Not described Receives: Drug: PVB morphine |
| PVB bupivacaine | Active comparator | Not described Receives: Drug: PVB bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour postoperative morphine consumption
the quantity of analgesic (morphine) consumed by the patient in the first postoperative 24 hour
Measured: the first postoperative 24 hour
Secondary outcomes (1)
VAS pain score (visual analogue pain score)
a scle in which 0 = no pain and 10 = maximum tolerable pain
Measured: we will assess every 4 hour in the first postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Jan 2018
- Primary completionJul 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diab Fuad Hetta, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379987
- Sponsor's protocol ID
- SECI-IRB-IORG0006563-404
- Status last verified
- Feb 2019
- First submitted
- 17 Dec 2017
- Last updated
- 11 Feb 2019
- 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 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Paravertebral Morphine for Acute Postoperative Pain: Randomized Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT03379987
- Acronym / sponsor ID
- SECI-IRB-IORG0006563-404
- Conditions
- Acute Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 20 Dec 2017 (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.
The investigator will test the analgesic efficacy of paravertebral morphine as an adjuvant to local anesthetics for acute postoperative pain following breast surgery and renal surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVB morphine | Experimental | Drug: PVB morphine |
| PVB bupivacaine | Active comparator | Drug: PVB bupivacaine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients subjected to mastectomy or renal surgery
Key exclusion criteria (2 listed)
- Patients complaining of coagulopathies
- Patients with vertebral anomalies
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 |
|---|---|---|
| PVB morphineThe PVB was performed under ultrasonographic guidance in the sitting position. Surgical disinfection of thoracoabdominal paravertebral area was done. A linear high-frequency transducer (10-12 MHz, Sonosite, Bothell, WA, USA) was used. The scanning process (Longitudinal out-of-plane technique) was started at 5-10 cm lateral to the spinous process of thoracic vertebrae to identify the rounded ribs and parietal pleura underneath. The transducer is then moved progressively more medially until the transverse processes are identified as more squared structure deeper to the ribs. A 100 mm needle was inserted out-of-plane to contact the transverse process of thoracic vertebra and then, walked off above the transverse process 1-1.5 cm deeper searching for loss of resistance injecting 10 ml of 0.25% bupivacaine + 3 mg morphine for group PVB morphine in incremental doses of 3 ml. | Drug | PVB morphine |
| PVB bupivacainethe same steps mentioned in group PVB morphine but the solution used for paravertebral block contain bupivacaine only 10 ml of 0.25% bupivacaine injected in in incremental doses of 3 ml. | Drug | PVB bupivacaine |
Primary outcome
24 hour postoperative morphine consumption
Time frame: the first postoperative 24 hour
the quantity of analgesic (morphine) consumed by the patient in the first postoperative 24 hour
1 secondary outcome
VAS pain score (visual analogue pain score)
Time frame: we will assess every 4 hour in the first postoperative 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
Related trials for Acute Pain
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVB morphine and PVB bupivacaine in people with Acute Pain, run by Assiut 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Feb 2019. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour postoperative morphine consumption (time frame: the first postoperative 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 11 Feb 2019.