Unilateral U/S PVBPhase 4NCT04396561
Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients
A Phase 4 study testing Paravertebral group (group P): in people with Unilateral U/S PVB, run by Cairo University at 1 site in Egypt.
Trial summary
Ultrasound imaging has revolutionized the practice of regional anesthesia in that the operator can visualize and identify the paravertebral space, needle during its passage through the tissues, as well as deposition and spread of local anesthetic into the desired spaces. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Unilateral U/S PVB
- What is being tested?
- Paravertebral group (group P):
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2020to 10 Jun 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physical status ASA II and III.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
- Patient undergoing lower limb-sparing surgery for cancer surgeries under general anesthesia.
Who cannot join
- Patient refusal.
- Known sensitivity or contraindication to local anesthetics.
- History of psychological disorders and/or chronic pain.
- Coagulopathies with INR ≥1.5: hereditary (e.g. hemophilia, fibrinogen abnormalities \& deficiency of factor II) - acquired (e.g. impaired liver functions with PC less than 60 %, vitamin K deficiency \& therapeutic anticoagulants drugs).
- Significant liver or renal insufficiency.
- Localized infection at the site of block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients: A Prospective, Randomized, Controlled Study
Ultrasound imaging has revolutionized the practice of regional anesthesia in that the operator can visualize and identify the paravertebral space, needle during its passage through the tissues, as well as deposition and spread of local anesthetic into the desired spaces. The usage of ultrasound may facilitate more rapid block onset and prolong duration with the added advantage of decrease in drug dosage, reduction in incidence of local anesthetic toxicity, increase success rate, reduction in procedure pain and better patient satisfaction.
Read the detailed description
Paravertebral block targets drug delivery to the site of pain, thus decreasing opioids use. It can provide greater overall comfort with lower pain scores and greater tolerance of physical activity during the initial postoperative period.
Ultrasound imaging has revolutionized the practice of regional anesthesia in that the operator can visualize and identify the paravertebral space, needle during its passage through the tissues, as well as deposition and spread of local anesthetic into the desired spaces. The usage of ultrasound may facilitate more rapid block onset and prolong duration with the added advantage of decrease in drug dosage, reduction in incidence of local anesthetic toxicity, increase success rate, reduction in procedure pain and better patient satisfaction.
To the best of researchers' knowledge, evaluation of unilateral ultrasound guided paravertebral block as perioperative analgesia for lower limb-sparing surgery in adult cancer patients was not investigated before.
- Conditions
- Unilateral U/S PVB
- Being tested
- Paravertebral group (group P):
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral group (group P):Drug
Also called Control group (group C):
In both groups, one reading of mean arterial pressure and heart rate were taken before induction of general anaesthesia and were defined as baseline readings and then were recorded intra-operatively at 15 min intervals.
Additional bolus doses of fentanyl 0.5µg/kg were given when the mean arterial blood pressure or heart rate raised above 20% of baseline levels.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral group (group P): | Experimental | After induction of general anesthesia and stabilization of the patients, they were positioned in lateral decubitus position with the side to be blocked uppermost. Receives: Drug: Paravertebral group (group P): |
| Control group (group C): | Experimental | Patients underwent surgery under general anesthesia and received the perioperative routine protocol of analgesia (IV fentanyl 2 μcg/kg at induction and 1 gm of IV paracetamol). Receives: Drug: Paravertebral group (group P): |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative fentanyl consumption.
Total intraoperative fentanyl consumption.
Measured: 24 hours
Secondary outcomes (3)
Visual Analouge Scale at 0 , 4 , 8 ,12 ,24 hours postoperatively.
Visual Analouge Scaleat 0 , 4 , 8 ,12 ,24 hours postoperatively.The VAS consists of a 10-cm line, with anchors at either end. One end is marked "no pain" and the other end is marked "the worst imaginable pain". The patient marks the place on the line to indicate his or her pain intensity. The clinician then measures the line with a ruler and assigns a score.
Measured: 24 hours
Heart rate and mean arterial blood pressure .
Heart rate(beat per minutes) and mean arterial blood pressure(mm HG)
Measured: 24 hours
Morphine consumption postoperatively for 24 hours..
Morphine consumption per mg postoperatively for 24 hours..
Measured: 24 hours Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start20 Jan 2020
- Primary completion9 Jun 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral U/S PVBStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled double-blind study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
- Investigators
- Ahmed Abdalla Mohamed, M.D, Principal investigator, Cairo UniversityEnas Mohamed Samir, M.D, Principal investigator, Cairo UniversityWalaa Y Elsabeeny, M.D, Study director, National Cancer Institute, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396561
- Sponsor's protocol ID
- MS-270-2019
- Status last verified
- Jun 2020
- First submitted
- 11 May 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Until ending the investigator's work
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients: A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT04396561
- Acronym / sponsor ID
- MS-270-2019
- Conditions
- Unilateral U/S PVB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 20 May 2020 (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.
Ultrasound imaging has revolutionized the practice of regional anesthesia in that the operator can visualize and identify the paravertebral space, needle during its passage through the tissues, as well as deposition and spread of local anesthetic into the desired spaces. The usage of ultrasound may facilitate more rapid block onset and prolong duration with the added advantage of decrease in drug dosage, reduction in incidence of local anesthetic toxicity, increase success rate, reduction in procedure pain and better patient satisfaction.
Detailed description
Paravertebral block targets drug delivery to the site of pain, thus decreasing opioids use. It can provide greater overall comfort with lower pain scores and greater tolerance of physical activity during the initial postoperative period.
Ultrasound imaging has revolutionized the practice of regional anesthesia in that the operator can visualize and identify the paravertebral space, needle during its passage through the tissues, as well as deposition and spread of local anesthetic into the desired spaces. The usage of ultrasound may facilitate more rapid block onset and prolong duration with the added advantage of decrease in drug dosage, reduction in incidence of local anesthetic toxicity, increase success rate, reduction in procedure pain and better patient satisfaction.
To the best of researchers' knowledge, evaluation of unilateral ultrasound guided paravertebral block as perioperative analgesia for lower limb-sparing surgery in adult cancer patients was not investigated before.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled double-blind study.
| Arm | Type | Receives |
|---|---|---|
| Paravertebral group (group P): | Experimental | Drug: Paravertebral group (group P):After induction of general anesthesia and stabilization of the patients, they were positioned in lateral decubitus position with the side to be blocked uppermost. |
| Control group (group C): | Experimental | Drug: Paravertebral group (group P):Patients underwent surgery under general anesthesia and received the perioperative routine protocol of analgesia (IV fentanyl 2 μcg/kg at induction and 1 gm of IV paracetamol). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Physical status ASA II and III.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
- Patient undergoing lower limb-sparing surgery for cancer surgeries under general anesthesia.
Key exclusion criteria (6 listed)
- Patient refusal.
- Known sensitivity or contraindication to local anesthetics.
- History of psychological disorders and/or chronic pain.
- Coagulopathies with INR ≥1.5: hereditary (e.g. hemophilia, fibrinogen abnormalities \& deficiency of factor II) - acquired (e.g. impaired liver functions with PC less than 60 %, vitamin K deficiency \& therapeutic anticoagulants drugs).
- Significant liver or renal insufficiency.
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 |
|---|---|---|
| Paravertebral group (group P):Also: Control group (group C):In both groups, one reading of mean arterial pressure and heart rate were taken before induction of general anaesthesia and were defined as baseline readings and then were recorded intra-operatively at 15 min intervals. Additional bolus doses of fentanyl 0.5µg/kg were given when the mean arterial blood pressure or heart rate raised above 20% of baseline levels. | Drug | Control group (group C):, Paravertebral group (group P): |
Primary outcome
Total intraoperative fentanyl consumption.
Time frame: 24 hours
Total intraoperative fentanyl consumption.
3 secondary outcomes
Visual Analouge Scale at 0 , 4 , 8 ,12 ,24 hours postoperatively.
Time frame: 24 hours
Heart rate and mean arterial blood pressure .
Time frame: 24 hours
Morphine consumption postoperatively for 24 hours..
Time frame: 24 hours Postoperative
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 16 Jun 2020.
- Individual participant dataSharing planned: No. Until ending the investigator's work
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.
Ahmed Abdalla Mohamed, M.D principal investigator
Cairo University
Enas Mohamed Samir, M.D principal investigator
Cairo University
Walaa Y Elsabeeny, M.D study director
National Cancer Institute, Cairo University
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 Paravertebral group (group P): in people with Unilateral U/S PVB, run by Cairo 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 16 Jun 2020. 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 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?
Total intraoperative fentanyl consumption. (time frame: 24 hours). 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 16 Jun 2020.