Pain, PostoperativeNCT06689358
Thoracic Paravertebral Block for Postoperative Pain Management After VATS
A study testing 0.4 ml/kg of 0.5% bupivacaine in people with Pain, Postoperative, run by King Hussein Cancer Center at 1 site in Jordan.
Trial summary
This randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (TPVB) in reducing opioid requirements and pain intensity in the PACU after video-assisted thoracoscopic surgery (VATS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- 0.4 ml/kg of 0.5% bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteJordan
- Study dates
- 1 Nov 2022to 1 Aug 2024
- 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 scheduled for elective VATS, ASA physical status II-III, BMI 19-40.
Who cannot join
- Patient refusal, coagulation disorders, contraindications to TPVB, chronic analgesic use, mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thoracic Paravertebral Block for Postoperative Pain Management in PACU After VATS Surgeries: A Randomized Controlled Trial
This randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (TPVB) in reducing opioid requirements and pain intensity in the PACU after video-assisted thoracoscopic surgery (VATS).
Read the detailed description
This randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (TPVB) in reducing opioid requirements and pain intensity in the PACU after video-assisted thoracoscopic surgery (VATS). Adult patients scheduled for elective VATS who meet the eligibility criteria will be randomized to either Arm:
Arm 1: General anesthesia with TPVB;
Arm 2: General anesthesia alone (control group).
Primary Outcome: to assess Opioid requirement in the PACU
- Conditions
- Pain, Postoperative
- Being tested
- 0.4 ml/kg of 0.5% bupivacaine
- Keywords
- Opioids, Pain Management,, Thoracic Paravertebral Block. VATS, Regional Anesthesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.4 ml/kg of 0.5% bupivacaineDrug
0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia with TPVB | Experimental | 0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space Receives: Drug: 0.4 ml/kg of 0.5% bupivacaine |
| General anesthesia alone (control group). | No intervention | General anesthesia SOC alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid requirement in the PACU
Opioid requirement in the PACU, recorded as "yes" or "no."
Measured: Opioid requirement assessed at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)
Secondary outcomes (1)
Pain intensity measured by Numeric Rating Scale -NRS
Pain intensity measured by Numeric Rating Scale- NRS at several time points, Range: 0 (no pain) to 10 (worst imaginable pain), Interpretation: Higher scores indicate worse pain intensity
Measured: Pain intensity measured using the Numeric Rating Scale (NRS) at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Nov 2022
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Model description
- Arm 1: General anesthesia with TPVB; Type: Experimental Intervention: 0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space. Arm 2: General anesthesia alone (control group). Type: No intervention (control) Intervention: No intervention
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Hussein Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahed Al-Edwan, MD, Principal investigator, KHCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689358
- Sponsor's protocol ID
- 22 KHCC 158
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Paravertebral Block for Postoperative Pain Management in PACU After VATS Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06689358
- Acronym / sponsor ID
- 22 KHCC 158
- Conditions
- Pain, Postoperative
- Keywords
- Opioids, Pain Management,, Thoracic Paravertebral Block. VATS, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- King Hussein Cancer CenterUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 14 Nov 2024 (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.
This randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (TPVB) in reducing opioid requirements and pain intensity in the PACU after video-assisted thoracoscopic surgery (VATS).
Detailed description
This randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (TPVB) in reducing opioid requirements and pain intensity in the PACU after video-assisted thoracoscopic surgery (VATS). Adult patients scheduled for elective VATS who meet the eligibility criteria will be randomized to either Arm:
Arm 1: General anesthesia with TPVB;
Arm 2: General anesthesia alone (control group).
Primary Outcome: to assess Opioid requirement in the PACU
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1: General anesthesia with TPVB; Type: Experimental Intervention: 0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space. Arm 2: General anesthesia alone (control group). Type: No intervention (control) Intervention: No intervention
| Arm | Type | Receives |
|---|---|---|
| General anesthesia with TPVB | Experimental | Drug: 0.4 ml/kg of 0.5% bupivacaine0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space |
| General anesthesia alone (control group). | No intervention | –General anesthesia SOC alone |
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 scheduled for elective VATS, ASA physical status II-III, BMI 19-40.
Key exclusion criteria (1 listed)
- Patient refusal, coagulation disorders, contraindications to TPVB, chronic analgesic use, mental illness
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 |
|---|---|---|
| 0.4 ml/kg of 0.5% bupivacaine0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space | Drug | General anesthesia with TPVB |
Primary outcome
Opioid requirement in the PACU
Time frame: Opioid requirement assessed at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)
Opioid requirement in the PACU, recorded as "yes" or "no."
1 secondary outcome
Pain intensity measured by Numeric Rating Scale -NRS
Time frame: Pain intensity measured using the Numeric Rating Scale (NRS) at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)
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 14 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Ahed Al-Edwan, MD principal investigator
KHCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.4 ml/kg of 0.5% bupivacaine in people with Pain, Postoperative, run by King Hussein Cancer Center at 1 site in Jordan.
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 1 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 14 Nov 2024. 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 Jordan. 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?
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?
Opioid requirement in the PACU (time frame: Opioid requirement assessed at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 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 14 Nov 2024.