Pain, PostoperativeNCT02671851
Ultrasound-Guided Thoracic Paravertebral Blocks in Patients Undergoing Reduction Mammoplasty
An observational study of Pain, Postoperative, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative analgesia in mastectomy, thoracic and video-assisted thoracic surgeries. Objective: To assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA) could postpone time to first pain and improve postoperative… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Thoracic paravertebral blocks (TPVBs) and IV metamizole sodium, paracetamol
- Type of treatment
- Injection or infusion
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Jan 2016
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients undergoing bilateral reduction mammoplasty
Who may be able to join
- ASA I-III patients who underwent bilateral reduction mammoplasty
Who cannot join
- Patients with deficient data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Department of Anaesthesiology
Istanbul, Istanbul, 34093
About this study
Official title: Ultrasound-Guided Bilateral Thoracic Paravertebral Blocks as an Adjunct to General Anaesthesia in Patients Undergoing Reduction Mammoplasty: A Historical Cohort Study
Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative analgesia in mastectomy, thoracic and video-assisted thoracic surgeries.
Objective: To assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA) could postpone time to first pain and improve postoperative analgesia in patients undergoing bilateral reduction mammoplasty.
Read more
Design: A historical cohort study. Patients: Of the 70 female patients who underwent bilateral reduction mammoplasty, 64 patients had complete data in the acute pain/regional anaesthesia database.
Intervention: Thirty patients, received only GA, were included in Group GA. Thirty-four patients, received bilateral single injection ultrasound-guided TPVBs with 20 mL bupivacaine 0.375% as an adjunct to GA, were included in Group TPVBs. Patients in both groups were administered intraoperative fentanyl if heart rate or mean arterial pressure increased >20% above pre-induction values, postoperative tramadol 1mg/kg in the postoperative care unit (PACU) if numeric rating scale (NRS) was ≥4, and rescue analgesics as metamizole sodium 4x1g and/or paracetamol 3x1g on wards (NRS≥4).
Main outcome measures: The primary endpoint was time to first pain after the surgery. Secondary endpoints were intra- and postoperative opioid and other rescue analgesic requirements, length of stay in the PACU, pain scores, incidence of postoperative nausea and vomiting (PONV), and patient and surgeon satisfaction through the postoperative first 2 days.
Read the detailed description
Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative analgesia in mastectomy, thoracic and video-assisted thoracic surgeries.
Objective: The objective was to assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA) could postpone time to first pain and improve postoperative analgesia in patients undergoing bilateral reduction mammoplasty.
Design: A historical cohort study. Patients: Of the 70 female patients who underwent bilateral reduction mammaplasty, 64 patients had complete data in the acute pain/regional anaesthesia database.
Intervention: Standard monitoring was applied before any anesthetic techniques were performed. All patients were given sedation in the form of midazolam 1-2 mg and fentanyl 50-100 µg. Patients underwent bilateral reduction mammaplasty were distributed to two groups due to their data: 1) Patients received only general anaesthesia (GA) were included in Group GA, and 2) Patients received preoperative US-guided TPVBs as an adjunct to GA were included in Group TPVBs. Thirty patients were in Group GA. Thirty-four patients who were in Group TPVBs received bilateral single injection ultrasound-guided TPVBs with 20 mL bupivacaine 0.375% (20 mL per injection) at the level of T3-4, as an adjunct to GA. Patients in both groups were administered intraoperative fentanyl if heart rate or mean arterial pressure increased >20% above pre-induction values. They also received postoperative tramadol 1mg/kg in the postoperative care unit (PACU) and rescue analgesics as metamizole sodium 4x1g and/or paracetamol 3x1g on wards, if numeric rating scale (NRS) was ≥4.
Main outcome measures: The primary endpoint was time to first pain after the surgery. Secondary endpoints were intra- and postoperative opioid and other rescue analgesic requirements, length of stay in the PACU, pain scores, incidence of postoperative nausea and vomiting (PONV), and patient and surgeon satisfaction through the postoperative first 2 days.
- Conditions
- Pain, Postoperative
- Being tested
- Thoracic paravertebral blocks (TPVBs), IV metamizole sodium, paracetamol
- Keywords
- Thoracic Paravertebral Blocks, Ultrasound Guidance, Reduction Mammoplasty, Time to First Pain, Postoperative Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic paravertebral blocks (TPVBs)Drug
Also called Bupivacaine,fentanyl,tramadol,metamizole sodium,paracetamol
Patients received bilateral single injection ultrasound-guided TPVBs with 20mL bupivacaine 0.375% at the level of T3-T4 as an adjunct to GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used.
IV metamizole sodium, paracetamolDrug
Also called Fentanyl,tramadol,metamizole sodium,paracetamol
Patients received only standardized GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic paravertebral blocks (TPVBs) | Patients received bilateral single injection ultrasound-guided TPVBs at the level of T3-T4 with 20 mL bupivacaine 0.375% as an adjunct to general anaesthesia. IV metamizole sodium and paracetamol were rescue analgesics. Receives: Drug: Thoracic paravertebral blocks (TPVBs) | |
| IV metamizole sodium, paracetamol | Patients received only standardized general anaesthesia. IV metamizole sodium and paracetamol were rescue analgesics. Receives: Drug: IV metamizole sodium, paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first pain
Postoperative first pain description NRS ≥4
Measured: 0-48 hours
Secondary outcomes (8)
Fentanyl use
Intraoperative fentanyl was used if heart rate or mean arterial pressure increased >20% above preinduction values
Measured: During the surgery
Tramadol use
Postoperative pain NRS ≥4 in the postoperative care unit
Measured: 0-2 hours
Rescue analgesic requirement
Postoperative pain NRS ≥4 on the wards
Measured: 0-48 hours
Length of stay in the PACU
White's Fast-Tracking Scoring System ≥12 was used for PACU discharge with no score of <1 in any category
Measured: 0-2 hours
Pain (NRS) scores
Numeric rating scale (NRS) pain scores (0: no pain, 10: worst pain imaginable)
Measured: 0-48 hours
Incidence of Postoperative nausea and vomiting (PONV)
Incidence of PONV
Measured: 0-48 hours
Patient satisfaction (Satisfaction scores)
Satisfaction scores (0: very unsatisfied, 3: very satisfied)
Measured: 0-48 hours
Surgeon satisfaction (Satisfaction scores)
Satisfaction scores (0: very unsatisfied, 3: very satisfied)
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Aysu Salviz, MD, Istanbul University
- Investigators
- Emine A Salviz, MD, Principal investigator, Design and conduct the study, review and analyze the data, and write the manuscript
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671851
- Sponsor's protocol ID
- 2016/83
- Status last verified
- Feb 2016
- First submitted
- 22 Jan 2016
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kaya FN, Turker G, Mogol EB, Bayraktar S. Thoracic paravertebral block for video-assisted thoracoscopic surgery: single injection versus multiple injections. J Cardiothorac Vasc Anesth. 2012 Feb;26(1):90-4. doi: 10.1053/j.jvca.2011.09.008. Epub 2011 Nov 4.
PubMed 22055006Kaya FN, Turker G, Basagan-Mogol E, Goren S, Bayram S, Gebitekin C. Preoperative multiple-injection thoracic paravertebral blocks reduce postoperative pain and analgesic requirements after video-assisted thoracic surgery. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):639-43. doi: 10.1053/j.jvca.2006.03.022. Epub 2006 Aug 8.
PubMed 17023279Moller JF, Nikolajsen L, Rodt SA, Ronning H, Carlsson PS. Thoracic paravertebral block for breast cancer surgery: a randomized double-blind study. Anesth Analg. 2007 Dec;105(6):1848-51, table of contents. doi: 10.1213/01.ane.0000286135.21333.fd.
PubMed 18042892Terheggen MA, Wille F, Borel Rinkes IH, Ionescu TI, Knape JT. Paravertebral blockade for minor breast surgery. Anesth Analg. 2002 Feb;94(2):355-9, table of contents. doi: 10.1097/00000539-200202000-00023.
PubMed 11812698Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.
PubMed 10825328
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Bilateral Thoracic Paravertebral Blocks as an Adjunct to General Anaesthesia in Patients Undergoing Reduction Mammoplasty: A Historical Cohort Study
- ClinicalTrials.gov ID
- NCT02671851
- Acronym / sponsor ID
- 2016/83
- Conditions
- Pain, Postoperative
- Keywords
- Thoracic Paravertebral Blocks, Ultrasound Guidance, Reduction Mammoplasty, Time to First Pain, Postoperative Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Feb 2016 (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.
Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative analgesia in mastectomy, thoracic and video-assisted thoracic surgeries.
Objective: To assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA) could postpone time to first pain and improve postoperative analgesia in patients undergoing bilateral reduction mammoplasty.
Design: A historical cohort study. Patients: Of the 70 female patients who underwent bilateral reduction mammoplasty, 64 patients had complete data in the acute pain/regional anaesthesia database.
Intervention: Thirty patients, received only GA, were included in Group GA. Thirty-four patients, received bilateral single injection ultrasound-guided TPVBs with 20 mL bupivacaine 0.375% as an adjunct to GA, were included in Group TPVBs. Patients in both groups were administered intraoperative fentanyl if heart rate or mean arterial pressure increased >20% above pre-induction values, postoperative tramadol 1mg/kg in the postoperative care unit (PACU) if numeric rating scale (NRS) was ≥4, and rescue analgesics as metamizole sodium 4x1g and/or paracetamol 3x1g on wards (NRS≥4).
Main outcome measures: The primary endpoint was time to first pain after the surgery. Secondary endpoints were intra- and postoperative opioid and other rescue analgesic requirements, length of stay in the PACU, pain scores, incidence of postoperative nausea and vomiting (PONV), and patient and surgeon satisfaction through the postoperative first 2 days.
Detailed description
Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative analgesia in mastectomy, thoracic and video-assisted thoracic surgeries.
Objective: The objective was to assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA) could postpone time to first pain and improve postoperative analgesia in patients undergoing bilateral reduction mammoplasty.
Design: A historical cohort study. Patients: Of the 70 female patients who underwent bilateral reduction mammaplasty, 64 patients had complete data in the acute pain/regional anaesthesia database.
Intervention: Standard monitoring was applied before any anesthetic techniques were performed. All patients were given sedation in the form of midazolam 1-2 mg and fentanyl 50-100 µg. Patients underwent bilateral reduction mammaplasty were distributed to two groups due to their data: 1) Patients received only general anaesthesia (GA) were included in Group GA, and 2) Patients received preoperative US-guided TPVBs as an adjunct to GA were included in Group TPVBs. Thirty patients were in Group GA. Thirty-four patients who were in Group TPVBs received bilateral single injection ultrasound-guided TPVBs with 20 mL bupivacaine 0.375% (20 mL per injection) at the level of T3-4, as an adjunct to GA. Patients in both groups were administered intraoperative fentanyl if heart rate or mean arterial pressure increased >20% above pre-induction values. They also received postoperative tramadol 1mg/kg in the postoperative care unit (PACU) and rescue analgesics as metamizole sodium 4x1g and/or paracetamol 3x1g on wards, if numeric rating scale (NRS) was ≥4.
Main outcome measures: The primary endpoint was time to first pain after the surgery. Secondary endpoints were intra- and postoperative opioid and other rescue analgesic requirements, length of stay in the PACU, pain scores, incidence of postoperative nausea and vomiting (PONV), and patient and surgeon satisfaction through the postoperative first 2 days.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic paravertebral blocks (TPVBs) | – | Drug: Thoracic paravertebral blocks (TPVBs)Patients received bilateral single injection ultrasound-guided TPVBs at the level of T3-T4 with 20 mL bupivacaine 0.375% as an adjunct to general anaesthesia. IV metamizole sodium and paracetamol were rescue analgesics. |
| IV metamizole sodium, paracetamol | – | Drug: IV metamizole sodium, paracetamolPatients received only standardized general anaesthesia. IV metamizole sodium and paracetamol were rescue analgesics. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients undergoing bilateral reduction mammoplasty
Key inclusion criteria (1 listed)
- ASA I-III patients who underwent bilateral reduction mammoplasty
Key exclusion criteria (1 listed)
- Patients with deficient data
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 |
|---|---|---|
| Thoracic paravertebral blocks (TPVBs)Also: Bupivacaine,fentanyl,tramadol,metamizole sodium,paracetamolPatients received bilateral single injection ultrasound-guided TPVBs with 20mL bupivacaine 0.375% at the level of T3-T4 as an adjunct to GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used. | Drug | Thoracic paravertebral blocks (TPVBs) |
| IV metamizole sodium, paracetamolAlso: Fentanyl,tramadol,metamizole sodium,paracetamolPatients received only standardized GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used. | Drug | IV metamizole sodium, paracetamol |
Primary outcome
Time to first pain
Time frame: 0-48 hours
Postoperative first pain description NRS ≥4
8 secondary outcomes
Fentanyl use
Time frame: During the surgery
Tramadol use
Time frame: 0-2 hours
Rescue analgesic requirement
Time frame: 0-48 hours
Length of stay in the PACU
Time frame: 0-2 hours
Pain (NRS) scores
Time frame: 0-48 hours
Incidence of Postoperative nausea and vomiting (PONV)
Time frame: 0-48 hours
Patient satisfaction (Satisfaction scores)
Time frame: 0-48 hours
Surgeon satisfaction (Satisfaction scores)
Time frame: 0-48 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 10 Feb 2016.
- Results publication: PubMed 22055006Kaya FN, Turker G, Mogol EB, Bayraktar S. Thoracic paravertebral block for video-assisted thoracoscopic surgery: single injection versus multiple injections. J Cardiothorac Vasc Anesth. 2012 Feb;26(1):90-4. doi: 10.1053/j.jvca.2011.09.008. Epub 2011 Nov 4.
- Results publication: PubMed 17023279Kaya FN, Turker G, Basagan-Mogol E, Goren S, Bayram S, Gebitekin C. Preoperative multiple-injection thoracic paravertebral blocks reduce postoperative pain and analgesic requirements after video-assisted thoracic surgery. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):639-43. doi: 10.1053/j.jvca.2006.03.022. Epub 2006 Aug 8.
- Results publication: PubMed 18042892Moller JF, Nikolajsen L, Rodt SA, Ronning H, Carlsson PS. Thoracic paravertebral block for breast cancer surgery: a randomized double-blind study. Anesth Analg. 2007 Dec;105(6):1848-51, table of contents. doi: 10.1213/01.ane.0000286135.21333.fd.
- Results publication: PubMed 11812698Terheggen MA, Wille F, Borel Rinkes IH, Ionescu TI, Knape JT. Paravertebral blockade for minor breast surgery. Anesth Analg. 2002 Feb;94(2):355-9, table of contents. doi: 10.1097/00000539-200202000-00023.
- Results publication: PubMed 10825328Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.
- 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.
Emine A Salviz, MD principal investigator
Design and conduct the study, review and analyze the data, and write the manuscript
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Istanbul 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 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 10 Feb 2016. 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?
Time to first pain (time frame: 0-48 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 NCT02671851, which also lists 5 linked publications.
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 10 Feb 2016.