Postoperative PainNCT04999319
Morphine Consumption in Thoracotomy
A study testing PVB and ESPB in people with Postoperative Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Importance of effective postoperative pain management is well known. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Thoracotomy operations are associated with high levels of pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- PVB and ESPB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2020to 25 Jan 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III patients undergo elective thoracotomy surgeries.
Who cannot join
- Obesity (BMI > 35 kg/m2)
- Infection of the skin at the site of the needle puncture area
- Patients with known allergies to any of the study drugs
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Morphine Consumption at Postoperative 24th Hour in Thoracotomy: A Randomized Controlled Trial
Importance of effective postoperative pain management is well known. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Thoracotomy operations are associated with high levels of pain. With the use of ultrasound, many regional anesthesia techniques were described to provide effective postoperative analgesia. The aim of this study was to compare the postoperative effect of paravertebral block (PVB) and erector spinal plane block (ESPB) in thoracotomies.
- Conditions
- Postoperative Pain
- Being tested
- PVB, ESPB
- Keywords
- Postoperative pain, Thoracotomy, Paravertebral block, Erector spina plane 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.
PVBProcedure or surgery
Paravertebral block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level.
ESPBProcedure or surgery
Erector spinae plane block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level.
| Study group | Role | What they receive |
|---|---|---|
| PVB Group | Active comparator | Paravertebral block administered group Receives: Procedure: PVB |
| ESPB group | Active comparator | Erector spinae plane block administered group Receives: Procedure: ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Morphine consumption (mg) of patients with patient controlled analgesia device
Measured: Postoperative 24th hour
NRS score
Numerating rating scale of the patients (between 0 and 10, 0 represents no pain and 10 represents the worst pain ever possible.
Measured: Postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start15 Oct 2020
- Primary completion5 Jan 2022
- Study completion25 Jan 2022
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Duran, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999319
- Sponsor's protocol ID
- GOKAEK-2020/18.09
- Status last verified
- Jan 2022
- First submitted
- 5 Aug 2021
- Last updated
- 26 Jan 2022
- 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 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Morphine Consumption at Postoperative 24th Hour in Thoracotomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04999319
- Acronym / sponsor ID
- GOKAEK-2020/18.09
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Thoracotomy, Paravertebral block, Erector spina plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 10 Aug 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.
Importance of effective postoperative pain management is well known. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Thoracotomy operations are associated with high levels of pain. With the use of ultrasound, many regional anesthesia techniques were described to provide effective postoperative analgesia. The aim of this study was to compare the postoperative effect of paravertebral block (PVB) and erector spinal plane block (ESPB) in thoracotomies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVB Group | Active comparator | Procedure: PVBParavertebral block administered group |
| ESPB group | Active comparator | Procedure: ESPBErector spinae plane block administered group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-III patients undergo elective thoracotomy surgeries.
Key exclusion criteria (4 listed)
- Obesity (BMI > 35 kg/m2)
- Infection of the skin at the site of the needle puncture area
- Patients with known allergies to any of the study drugs
- Coagulopathy
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 |
|---|---|---|
| PVBParavertebral block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level. | Procedure or surgery | PVB Group |
| ESPBErector spinae plane block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level. | Procedure or surgery | ESPB group |
Primary outcome
Morphine consumption
Time frame: Postoperative 24th hour
Morphine consumption (mg) of patients with patient controlled analgesia device
NRS score
Time frame: Postoperative 24th hour
Numerating rating scale of the patients (between 0 and 10, 0 represents no pain and 10 represents the worst pain ever possible.
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 26 Jan 2022.
- 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.
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 study testing PVB and ESPB in people with Postoperative Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 4 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 26 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 Turkey (Türkiye). 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?
Morphine consumption (time frame: Postoperative 24th hour). The study lists 2 primary outcomes in all. 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 26 Jan 2022; AzTrials last refreshed its copy on 27 Oct 2026.