Breast Cancer FemaleNCT04056676
Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery
A study testing Thoracic paravertebral block under ultrasound guidance, Intraoperative modified PEC block and GA with ETT in people with Breast Cancer Female and Pain, Postoperative, run by Mahidol University at 1 site in Thailand.
Trial summary
To compare efficacy and safety of adding thoracic paravertebral nerve blocks to modified PEC block versus modified PEC block only in breast cancer surgery. This study evaluate systemic opioid requirement in 48 hours in primary outcome and the analgesic profile ( pain score at rest and on shoulder movement)… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Female, Pain, Postoperative
- What is being tested?
- Thoracic paravertebral block under ultrasound guidance, Intraoperative modified PEC block and GA with ETT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2019to 1 Mar 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) grade I-III
- Aged ≥ 18-80 years old
- Elective unilateral total mastectomy with sentinel lymph node biopsy or lymph node dissection
Who cannot join
- Patient refusal
- Language barrier or inability to communicate with the operating team
- Allergy to local anesthetic
- Bleeding disorder
- Previous breast surgery or thoracic radiation therapy
- BMI ≥ 30
- Patient who can not understand the proper use of intravenous patient-controlled analgesia machine or who has the problem with communication
- Chronic pain patient
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
Suwimon Tangwiwat, M.D, (66)81-645-6167, stangwiwat@yahoo.com
About this study
Official title: Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery, Prospective Randomized Controlled Study
To compare efficacy and safety of adding thoracic paravertebral nerve blocks to modified PEC block versus modified PEC block only in breast cancer surgery. This study evaluate systemic opioid requirement in 48 hours in primary outcome and the analgesic profile ( pain score at rest and on shoulder movement), opioid-related side effects and nerve blocks complications.
Read the detailed description
Regional anesthesia has been used and studied extensively in breast surgery as an opioid-sparing strategy, with block of the intercostal supply by thoracic paravertebral block (TPVB) becoming a popular technique.
This prospective randomized controlled trial is aimed to study the proper regional nerve block technique to reach the postoperative opioid-free requirement modality for breast cancer surgery.
- Conditions
- Breast Cancer Female, Pain, Postoperative
- Being tested
- Thoracic paravertebral block under ultrasound guidance, Intraoperative modified PEC block, GA with ETT
- Keywords
- Postoperative pain, Thoracic paravertebral block, Modified PEC block, Breast cancer, Total mastectomy with sentinel lymph node clearance
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic paravertebral block under ultrasound guidanceProcedure or surgery
Also called USG-TPVB
Ultrasound-guided thoracic paravertebral blocks in T2, T4 level
Intraoperative modified PEC blockProcedure or surgery
Also called Modified PEC block
Pectoral nerve block by surgeon under direct vision after total mastectomy
GA with ETTProcedure or surgery
General anesthesia with endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative modified PEC block only | Active comparator | Intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon Receives: Procedure: Intraoperative modified PEC block; Procedure: GA with ETT |
| Adding preoperative thoracic paravertebral nerve block | Experimental | Preoperative thoracic paravertebral nerve block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug and intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon Receives: Procedure: Thoracic paravertebral block under ultrasound guidance; Procedure: Intraoperative modified PEC block; Procedure: GA with ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative fentanyl consumption
Cumulative fentanyl consumption within postoperative 24 hours
Measured: at postoperative 24 hours
Postoperative fentanyl consumption
Cumulative fentanyl consumption within postoperative 24-48 hours
Measured: at postoperative 48 hours
Secondary outcomes (17)
Intraoperative fentanyl use
Dosage of intraoperative fentanyl usage in micrograms
Measured: Intraoperation
Postoperative pain score at rest
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Measured: at postoperative 0 hour (PACU arrival)
Postoperative pain score at rest
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Measured: at postoperative 30 min (in PACU)
Postoperative pain score at rest
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Measured: at postoperative 1 hour (in PACU)
Postoperative pain score at rest
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Measured: Postoperative 6 hour (at ward)
Postoperative pain score at rest
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Measured: Postoperative 12 hour (at ward)
Postoperative pain score at rest
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Measured: Postoperative 18 hour (at ward)
Postoperative pain score at rest
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Measured: Postoperative 24 hour (at ward)
Postoperative pain score on shoulder movement
Numeric rating score ((0= no pain, 10= worst pain imaginable)
Measured: Postoperative 1 hour (at PACU)
Postoperative pain score on shoulder movement
Numeric rating score ((0= no pain, 10= worst pain imaginable)
Measured: Postoperative first day (at ward)
Postoperative pain score on shoulder movement
Numeric rating score ((0= no pain, 10= worst pain imaginable)
Measured: Postoperative second day (at ward)
First time to fentanyl requirement by IV PCA
time to require fentanyl patient-controlled intravenous analgesia
Measured: Within 24 hours
Percentage of patients presenting with opioid-related adverse effects
adverse effects include postoperative nausea, vomiting, dizziness, pruritus
Measured: Within 48 hours
Percentage of patients presenting with nerve block complications
nerve block complications include pneumothorax, hypotension, local anesthetic systemic toxicity, Horner syndrome
Measured: Within 48 hours
Length of hospital stay
Number of hospital admission days
Measured: From preoperative admission until hospital discharge
Patient's satisfaction scale score
Satisfaction scale score 0-10 (0= highly unsatisfied, 10= highly satisfied)
Measured: At postoperative 48 hours
Cost effectiveness analysis
Cost of adding nerve block and postoperative pain score
Measured: Within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Aug 2019
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Mahidol 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group A Intraoperative modified PEC block only group B Preoperative thoracic paravertebral block plus intraoperative modified PEC block
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suwimon Tangwiwat, Mahidol University
- Investigators
- Suwimon Tangwiwat, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056676
- Sponsor's protocol ID
- SI 475/2019
- Status last verified
- May 2021
- First submitted
- 8 Aug 2019
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Missair A, Cata JP, Votta-Velis G, Johnson M, Borgeat A, Tiouririne M, Gottumukkala V, Buggy D, Vallejo R, Marrero EB, Sessler D, Huntoon MA, Andres J, Casasola OL. Impact of perioperative pain management on cancer recurrence: an ASRA/ESRA special article. Reg Anesth Pain Med. 2019 Jan;44(1):13-28. doi: 10.1136/rapm-2018-000001.
PubMed 30640648Woodworth GE, Ivie RMJ, Nelson SM, Walker CM, Maniker RB. Perioperative Breast Analgesia: A Qualitative Review of Anatomy and Regional Techniques. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):609-631. doi: 10.1097/AAP.0000000000000641.
PubMed 28820803Wynne R, Lui N, Tytler K, Koffsovitz C, Kirwa V, Riedel B, Ryan S. The Trajectory of Postoperative Pain Following Mastectomy with and without Paravertebral Block. Pain Manag Nurs. 2017 Aug;18(4):234-242. doi: 10.1016/j.pmn.2017.03.003. Epub 2017 Jun 7.
PubMed 28601480Syal K, Chandel A. Comparison of the post-operative analgesic effect of paravertebral block, pectoral nerve block and local infiltration in patients undergoing modified radical mastectomy: A randomised double-blind trial. Indian J Anaesth. 2017 Aug;61(8):643-648. doi: 10.4103/ija.IJA_81_17.
PubMed 28890559Terkawi AS, Tsang S, Sessler DI, Terkawi RS, Nunemaker MS, Durieux ME, Shilling A. Improving Analgesic Efficacy and Safety of Thoracic Paravertebral Block for Breast Surgery: A Mixed-Effects Meta-Analysis. Pain Physician. 2015 Sep-Oct;18(5):E757-80.
PubMed 26431130Klein 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 10825328Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
PubMed 25376971
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery, Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04056676
- Acronym / sponsor ID
- SI 475/2019
- Conditions
- Breast Cancer Female, Pain, Postoperative
- Keywords
- Postoperative pain, Thoracic paravertebral block, Modified PEC block, Breast cancer, Total mastectomy with sentinel lymph node clearance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 14 Aug 2019 (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.
To compare efficacy and safety of adding thoracic paravertebral nerve blocks to modified PEC block versus modified PEC block only in breast cancer surgery. This study evaluate systemic opioid requirement in 48 hours in primary outcome and the analgesic profile ( pain score at rest and on shoulder movement), opioid-related side effects and nerve blocks complications.
Detailed description
Regional anesthesia has been used and studied extensively in breast surgery as an opioid-sparing strategy, with block of the intercostal supply by thoracic paravertebral block (TPVB) becoming a popular technique.
This prospective randomized controlled trial is aimed to study the proper regional nerve block technique to reach the postoperative opioid-free requirement modality for breast cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- group A Intraoperative modified PEC block only group B Preoperative thoracic paravertebral block plus intraoperative modified PEC block
| Arm | Type | Receives |
|---|---|---|
| Intraoperative modified PEC block only | Active comparator | Procedure: Intraoperative modified PEC block, Procedure: GA with ETTIntraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon |
| Adding preoperative thoracic paravertebral nerve block | Experimental | Procedure: Thoracic paravertebral block under ultrasound guidance, Procedure: Intraoperative modified PEC block, Procedure: GA with ETTPreoperative thoracic paravertebral nerve block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug and intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) grade I-III
- Aged ≥ 18-80 years old
- Elective unilateral total mastectomy with sentinel lymph node biopsy or lymph node dissection
Key exclusion criteria (8 listed)
- Patient refusal
- Language barrier or inability to communicate with the operating team
- Allergy to local anesthetic
- Bleeding disorder
- Previous breast surgery or thoracic radiation therapy
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 block under ultrasound guidanceAlso: USG-TPVBUltrasound-guided thoracic paravertebral blocks in T2, T4 level | Procedure or surgery | Adding preoperative thoracic paravertebral nerve block |
| Intraoperative modified PEC blockAlso: Modified PEC blockPectoral nerve block by surgeon under direct vision after total mastectomy | Procedure or surgery | Adding preoperative thoracic paravertebral nerve block, Intraoperative modified PEC block only |
| GA with ETTGeneral anesthesia with endotracheal intubation | Procedure or surgery | Adding preoperative thoracic paravertebral nerve block, Intraoperative modified PEC block only |
Primary outcome
Postoperative fentanyl consumption
Time frame: at postoperative 24 hours
Cumulative fentanyl consumption within postoperative 24 hours
Postoperative fentanyl consumption
Time frame: at postoperative 48 hours
Cumulative fentanyl consumption within postoperative 24-48 hours
17 secondary outcomes
Intraoperative fentanyl use
Time frame: Intraoperation
Postoperative pain score at rest
Time frame: at postoperative 0 hour (PACU arrival)
Postoperative pain score at rest
Time frame: at postoperative 30 min (in PACU)
Postoperative pain score at rest
Time frame: at postoperative 1 hour (in PACU)
Postoperative pain score at rest
Time frame: Postoperative 6 hour (at ward)
Postoperative pain score at rest
Time frame: Postoperative 12 hour (at ward)
Postoperative pain score at rest
Time frame: Postoperative 18 hour (at ward)
Postoperative pain score at rest
Time frame: Postoperative 24 hour (at ward)
Postoperative pain score on shoulder movement
Time frame: Postoperative 1 hour (at PACU)
Postoperative pain score on shoulder movement
Time frame: Postoperative first day (at ward)
Postoperative pain score on shoulder movement
Time frame: Postoperative second day (at ward)
First time to fentanyl requirement by IV PCA
Time frame: Within 24 hours
Percentage of patients presenting with opioid-related adverse effects
Time frame: Within 48 hours
Percentage of patients presenting with nerve block complications
Time frame: Within 48 hours
Length of hospital stay
Time frame: From preoperative admission until hospital discharge
Patient's satisfaction scale score
Time frame: At postoperative 48 hours
Cost effectiveness analysis
Time frame: Within 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Background: PubMed 30640648Missair A, Cata JP, Votta-Velis G, Johnson M, Borgeat A, Tiouririne M, Gottumukkala V, Buggy D, Vallejo R, Marrero EB, Sessler D, Huntoon MA, Andres J, Casasola OL. Impact of perioperative pain management on cancer recurrence: an ASRA/ESRA special article. Reg Anesth Pain Med. 2019 Jan;44(1):13-28. doi: 10.1136/rapm-2018-000001.
- Background: PubMed 28820803Woodworth GE, Ivie RMJ, Nelson SM, Walker CM, Maniker RB. Perioperative Breast Analgesia: A Qualitative Review of Anatomy and Regional Techniques. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):609-631. doi: 10.1097/AAP.0000000000000641.
- Background: PubMed 28601480Wynne R, Lui N, Tytler K, Koffsovitz C, Kirwa V, Riedel B, Ryan S. The Trajectory of Postoperative Pain Following Mastectomy with and without Paravertebral Block. Pain Manag Nurs. 2017 Aug;18(4):234-242. doi: 10.1016/j.pmn.2017.03.003. Epub 2017 Jun 7.
- Background: PubMed 28890559Syal K, Chandel A. Comparison of the post-operative analgesic effect of paravertebral block, pectoral nerve block and local infiltration in patients undergoing modified radical mastectomy: A randomised double-blind trial. Indian J Anaesth. 2017 Aug;61(8):643-648. doi: 10.4103/ija.IJA_81_17.
- Background: PubMed 26431130Terkawi AS, Tsang S, Sessler DI, Terkawi RS, Nunemaker MS, Durieux ME, Shilling A. Improving Analgesic Efficacy and Safety of Thoracic Paravertebral Block for Breast Surgery: A Mixed-Effects Meta-Analysis. Pain Physician. 2015 Sep-Oct;18(5):E757-80.
- Background: 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.
- Background: PubMed 25376971Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
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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.
Suwimon Tangwiwat, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic paravertebral block under ultrasound guidance, Intraoperative modified PEC block and GA with ETT in people with Breast Cancer Female and Pain, Postoperative, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 May 2021. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suwimon Tangwiwat, MD (66816456167, stangwiwat@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative fentanyl consumption (time frame: at postoperative 24 hours). 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?
On the ClinicalTrials.gov record for NCT04056676, which also lists 7 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 24 May 2021.