Postoperative PainPhase 4NCT02412930
Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol in Percutaneous Nephrolithotomy
A Phase 4 study testing Ultrasound-guided Paravertebral Block, Group Tramadol and Bupivacaine in people with Postoperative Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Paravertebral block has been widely used for analgesia. The aim of this study,comparison of the effect of ultrasound-guided paravertebral block versus intravenous tramadol for postoperative pain control in percutaneous nephrolithotomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ultrasound-guided Paravertebral Block, Group Tramadol and Bupivacaine
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2012to Apr 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 53 patients scheduled for percutaneous nephrolithotomy (PNL),
- 18-70 years of age,
- weight between 50-100 kg,
- American Society of Anesthesiologists (ASA) classification I-II were included
Who cannot join
- The exclusion criteria were refusals by patients,
- coagulation abnormalities,
- patients with spinal deformity,
- cutaneous infection at the injection site and
- a known allergy to drugs.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University Faculty of Medicine
Adana, 01230
About this study
Official title: Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol for Postoperative Pain Control in Percutaneous Nephrolithotomy
Paravertebral block has been widely used for analgesia. The aim of this study,comparison of the effect of ultrasound-guided paravertebral block versus intravenous tramadol for postoperative pain control in percutaneous nephrolithotomy.
Read the detailed description
The study protocol was approved by the Local Ethical Committee. Written informed consent was obtained from all patients, before starting to surgery.
The patients were given no premedication. The demographic data of patients (age, gender, the presence of other diseases) were recorded, preoperatively. All patients were applied standard monitoring in the operating room. After the induction of anesthesia provided intravenously propofol (2-3mg/kg) and rocuronium bromide (0.5 mgkg-1), all patients were intubated with a suitable endotracheal tube. Anesthesia maintenance was provided with 1-2% sevoflurane and a 60% nitrous oxide-40% oxygen gas mixture. 0.9% NaCl (5-10 mLkg-1) was started as fluid resuscitation. Urinary catheter was inserted before placement, and then all patients were placed in the prone position.
Postoperatively, duration of surgery, systolic and diastolic blood pressures, heart rate, peripheral oxygen saturation (SBP, DBP, HR, and SpO2), visual analog scales (VAS), side effects such as vomiting and nausea, complications such as pneumothorax, tramadol consumption and additional analgesic requirements of patients were recorded at 1, 2, 4, 6, 12 and 24 h in the postoperative period. These parameters were evaluated by an anesthesiologist in the first 24 hours postoperatively. If the VAS score was >4, patients in both groups were administered diclofenac.
- Conditions
- Postoperative Pain
- Being tested
- Ultrasound-guided Paravertebral Block, Group Tramadol, Bupivacaine, Ultrasound
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Paravertebral BlockProcedure or surgery
paravertebral block was performed by ultrasound guidance at T11, T12 and L1 levels, using 0.5% bupivacaine total dose of 15 mL in group P. The injection site was covered with sterile drapes, after cleaning with 10% povidone-iodine solution.
After, patients in both groups were performed patient controlled analgesia (PCA). The PCA was prepared with 400 mg tramadol into 100 mL of saline. The doses of tramadol in the PCA were bolus dose 0.1 mgkg-1 every 20 minutes without a background infusion.
Group TramadolDrug
Patients in group T were given intravenously a loading dose of tramadol of 1 mgkg-1, 45 minutes before the end of surgery. After,patients in both groups were performed patient controlled analgesia (PCA). The PCA (CADD Legacy PCA pump, Smiths Medical MD, Inc., St. Paul, MN) was prepared with 400 mg tramadol into 100 mL of saline. The doses of tramadol in the PCA were bolus dose 0.1 mgkg-1 every 20 minutes without a background infusion.
BupivacaineDrug
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Group Paravertebral Block | Active comparator | With ultrasound guidance at T10 to L1 levels, using 0.5% bupivacaine total dose of 15 mL in group P. 5 mL bupivacaine 0.5% was injected in each dermatome level. Receives: Procedure: Ultrasound-guided Paravertebral Block; Drug: Group Tramadol; Drug: Bupivacaine; Device: Ultrasound |
| Group tramadol | Placebo comparator | Patients in group T were given a loading dose of tramadol of 1 mgkg-1 Receives: Drug: Group Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Postoperative pain degree was evaluated by Visual Analogue Scale
Measured: up to 24 hours
Secondary outcomes (1)
tramadol consumption
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startMar 2012
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra, Cukurova University
- Investigators
- Zehra Hatipoğlu, Assist Prof, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412930
- Sponsor's protocol ID
- 5/8-2012
- Status last verified
- Mar 2017
- First submitted
- 27 Mar 2015
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hatipoglu Z, Gulec E, Turktan M, Izol V, Aridogan A, Gunes Y, Ozcengiz D. Comparative study of ultrasound-guided paravertebral block versus intravenous tramadol for postoperative pain control in percutaneous nephrolithotomy. BMC Anesthesiol. 2018 Feb 17;18(1):24. doi: 10.1186/s12871-018-0479-7.
PubMed 29454333
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol for Postoperative Pain Control in Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT02412930
- Acronym / sponsor ID
- 5/8-2012
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 9 Apr 2015 (estimated)
- 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.
Paravertebral block has been widely used for analgesia. The aim of this study,comparison of the effect of ultrasound-guided paravertebral block versus intravenous tramadol for postoperative pain control in percutaneous nephrolithotomy.
Detailed description
The study protocol was approved by the Local Ethical Committee. Written informed consent was obtained from all patients, before starting to surgery.
The patients were given no premedication. The demographic data of patients (age, gender, the presence of other diseases) were recorded, preoperatively. All patients were applied standard monitoring in the operating room. After the induction of anesthesia provided intravenously propofol (2-3mg/kg) and rocuronium bromide (0.5 mgkg-1), all patients were intubated with a suitable endotracheal tube. Anesthesia maintenance was provided with 1-2% sevoflurane and a 60% nitrous oxide-40% oxygen gas mixture. 0.9% NaCl (5-10 mLkg-1) was started as fluid resuscitation. Urinary catheter was inserted before placement, and then all patients were placed in the prone position.
Postoperatively, duration of surgery, systolic and diastolic blood pressures, heart rate, peripheral oxygen saturation (SBP, DBP, HR, and SpO2), visual analog scales (VAS), side effects such as vomiting and nausea, complications such as pneumothorax, tramadol consumption and additional analgesic requirements of patients were recorded at 1, 2, 4, 6, 12 and 24 h in the postoperative period. These parameters were evaluated by an anesthesiologist in the first 24 hours postoperatively. If the VAS score was >4, patients in both groups were administered diclofenac.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Paravertebral Block | Active comparator | Procedure: Ultrasound-guided Paravertebral Block, Drug: Group Tramadol, Drug: Bupivacaine, Device: UltrasoundWith ultrasound guidance at T10 to L1 levels, using 0.5% bupivacaine total dose of 15 mL in group P. 5 mL bupivacaine 0.5% was injected in each dermatome level. |
| Group tramadol | Placebo comparator | Drug: Group TramadolPatients in group T were given a loading dose of tramadol of 1 mgkg-1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 53 patients scheduled for percutaneous nephrolithotomy (PNL),
- 18-70 years of age,
- weight between 50-100 kg,
- American Society of Anesthesiologists (ASA) classification I-II were included
Key exclusion criteria (5 listed)
- The exclusion criteria were refusals by patients,
- coagulation abnormalities,
- patients with spinal deformity,
- cutaneous infection at the injection site and
- a known allergy to drugs.
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 Paravertebral Blockparavertebral block was performed by ultrasound guidance at T11, T12 and L1 levels, using 0.5% bupivacaine total dose of 15 mL in group P. The injection site was covered with sterile drapes, after cleaning with 10% povidone-iodine solution. After, patients in both groups were performed patient controlled analgesia (PCA). The PCA was prepared with 400 mg tramadol into 100 mL of saline. The doses of tramadol in the PCA were bolus dose 0.1 mgkg-1 every 20 minutes without a background infusion. | Procedure or surgery | Group Paravertebral Block |
| Group TramadolPatients in group T were given intravenously a loading dose of tramadol of 1 mgkg-1, 45 minutes before the end of surgery. After,patients in both groups were performed patient controlled analgesia (PCA). The PCA (CADD Legacy PCA pump, Smiths Medical MD, Inc., St. Paul, MN) was prepared with 400 mg tramadol into 100 mL of saline. The doses of tramadol in the PCA were bolus dose 0.1 mgkg-1 every 20 minutes without a background infusion. | Drug | Group Paravertebral Block, Group tramadol |
| Bupivacaine | Drug | Group Paravertebral Block |
| Ultrasound | Device | Group Paravertebral Block |
Primary outcome
Visual Analogue Scale
Time frame: up to 24 hours
Postoperative pain degree was evaluated by Visual Analogue Scale
1 secondary outcome
tramadol consumption
Time frame: up to 24 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 22 Mar 2017.
- Derived from this study: PubMed 29454333Hatipoglu Z, Gulec E, Turktan M, Izol V, Aridogan A, Gunes Y, Ozcengiz D. Comparative study of ultrasound-guided paravertebral block versus intravenous tramadol for postoperative pain control in percutaneous nephrolithotomy. BMC Anesthesiol. 2018 Feb 17;18(1):24. doi: 10.1186/s12871-018-0479-7.
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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.
Zehra Hatipoğlu, Assist Prof principal investigator
Cukurova 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 Ultrasound-guided Paravertebral Block, Group Tramadol and Bupivacaine in people with Postoperative Pain, run by Cukurova 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 4 inclusion and 5 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 22 Mar 2017. 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. Some participants in this study may receive a placebo. 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?
Visual Analogue Scale (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02412930, which also lists 1 linked publication.
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 22 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.