AnesthesiaNCT03740815
Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection
A study testing Serratus plane block, Axillary dissection and Intravenous sedation in people with Anesthesia and Regional Anesthesia Morbidity, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
Trial summary
INTRODUCTION: The axillary lymphadenectomy procedure is known to be associated with late postoperative complications, such as chronic pain and changes in shoulder mobility. Recently, several thoracic ultrasound guided interfascial blocks have been described, including serratus plane block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Regional Anesthesia Morbidity, Axillary Metastases
- What is being tested?
- Serratus plane block, Axillary dissection and Intravenous sedation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Sep 2018to 2 Mar 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergo axillary dissection due to metastatic skin or soft tissue cancer;
- ASA physical status classification between I and III;
- have signed the informed consent.
Who cannot join
- weight less than 40 kilograms;
- tumor affecting topography to be blocked;
- presence of ulcerated lesion in the axilla;
- presence of coagulopathy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital do Câncer II - National Cancer Institute of Brazil (INCA - Brazil)
Rio de Janeiro, Rio de Janeiro/RJ, 20220-410
About this study
Official title: Assessment of the Feasibility of Ultrasound Guided Serratus Plane Block Associated With Sedation as Anesthetic Technique in Axillary Dissection
INTRODUCTION: The axillary lymphadenectomy procedure is known to be associated with late postoperative complications, such as chronic pain and changes in shoulder mobility. Recently, several thoracic ultrasound guided interfascial blocks have been described, including serratus plane block. These blocks were associated with reduced postoperative pain scores in breast surgeries but were never evaluated in axillary dissection. The safety and feasibility of performing axillary dissection under local anesthesia and tumescent anesthesia associated with sedation has been demonstrated in case series, although it is not already the standard technique.
DISCUSSION: This project aims to investigate the feasibility of the serratus plane block associated with intra-venous sedation in a prospective case series including 15 patients submitted to axillary dissection, by scoring patient and surgeon satisfaction with the technique, pain, quality of life with EORTC QLQ-C30 questionnaire, and quality of recovery with QoR-40 questionnaire in the first 30 postoperative days.
Read the detailed description
This study is a prospective case series. All patients should go through a preoperative evaluation with an anesthesiologist. At that time the eligibility for the study will be evaluated and if the patient consent to participate in the study.
The following parameters shall be evaluated in the ambulatory evaluation:
- Age
- Anthropometric data (weight and height);
- Presence of comorbidities;
- Revised cardiac index (LEE);
- Estimation of functional capacity in metabolic equivalents (METs) by history;
- Performance Status by the scale of Eastern Cooperative Oncology Group (ECOG);
- Determination of the physical status by the American Society of Anesthesiologists (ASA) classification;
- QoR-40 recovery quality scale, validated for Brazilian Portuguese;
- Quality of life EORTC QLQ-C30 questionnaire, validated for Brazilian Portuguese.
During the anesthetic procedure, the following standard technique should be applied: peripheral venous access, dipyrone 30 mg/kg, antibiotic according to the institutional protocol, moderate sedation with intravenous propofol in continuous infusion in the absence of any contraindication. Midazolam will be used in case of contraindication to propofol or during the execution of the block according to preference of the researcher who will perform the block. Associated with propofol infusion, the alpha agonist dexmedetomidine may be used in continuous infusion associated with fentanyl, tramadol, dextroketamine, magnesium sulfate, dipyrone and tenoxicam, whose uses will be evaluated on a case-by-case basis and will be recorded in the database.
In case of conversion to general anesthesia, the airway control should be carried out preferably with laryngeal mask, with the orotracheal intubation as an alternative option. The maintenance of anesthesia will be in this case using propofol continuous infusion in the absence of contraindications, otherwise sevoflurane will be used. Postoperative nausea and vomiting prophylaxis will be done with four milligrams of dexamethasone and ondansetron.
Patients will be submitted serratus plane block according to the technique described in Blanco. The patients will be positioned in a supine position. The transducer of the ultrasound device is protected with sterile cover. The ultrasound probe is positioned in the mid clavicular region of the thoracic wall in a sagittal plane. Using a nether-lateral path with the probe, will be counted the ribs, until the fifth rib is identified in the mid axillary line. In this position, over the fifth rib, the latissimus dorsi muscle superficially and the serratus muscle deeper and lower can be easily observed. The identification of the thoracodorsal artery with use of doppler imaging assists in identifying the superficial plane to the serratus muscle. Once identified the structures, the needle is introduced in the plane of the transducer positioning its tip on the surface of the serratus muscle. Then 40 ml of solution with 1% lidocaine, adrenaline 1:200,000 and ropivacaine 0.5% are injected in patients above 50kg and 32ml of the same solution in patients with body weight between 40 and 50kg aiming to respect the maximum dose of local anesthetic recommended.
At the end of the surgical procedure the patient will be referred to the anesthetic recovery unit. The extension of the blockade will be then evaluated. They will be discharged to ward as soon as they get the discharge criteria.
The surgical time, time for execution of the blockage (counted from the placement of the sterile field until the removal of the needle), the surgical room time, estimated bleeding, presence of surgical complications or anesthetic and number of lymph nodes extracted will be registered. At the end of the surgery the surgeon will be asked to fill out a range of Likert 5 points on his opinion on the quality of anesthesia (extremely satisfied, satisfied, not satisfied or dissatisfied, dissatisfied, extremely dissatisfied) and to compare the quality of anesthesia with general anesthesia on a 3-point scale (indistinguishable from general anesthesia, sufficient to perform the procedure, extremely challenging/inadequate).
On the first day of postoperative the standard analgesia will be carried out with dipyrone 30 mg/kg IV every 4 hours, associated with tenoxicam 20mg every 12 hours. In case of contraindication to dipyrone, will be administered paracetamol 500 mg VO every 6 hours. As a rescue therapy the default option is tramadol 50mg IV up to every 4 hours (daily maximum dose of 300mg/day and morphine 4 mg each hour (in case of allergy or intolerance to tramadol and rescue the tramadol). If necessary more than 24 hours of hospitalization, postoperative analgesia will be performed as option of the assistant team. The use of postoperative painkillers will be recorded in the database.
All patients should be evaluated on the first postoperative day with record of the verbal numerical scale for the evaluation of pain at rest, cough and abduction of 90 Degrees of the member and the presence of adverse effects. They be asked to fill the scale of Likert of 5 points with his opinion on the quality of anesthesia (extremely satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, extremely dissatisfied) and the scale of recovery quality QoR-40. Between the twenty-eighth and the thirtieth-fifth postoperative day All patients will be reassessed, occasion where the scale of recovery quality QoR-40 and the scale of quality of life EORTC QLQ-C30, presence of surgical wound infection will be applied, cutaneous necrosis, seroma, lymphedema, lymphatic fistula and date of drain removal.
- Conditions
- Anesthesia, Regional Anesthesia Morbidity, Axillary Metastases, Nerve Block, Analgesia, Skin Cancer
- Being tested
- Serratus plane block, Axillary dissection, Intravenous sedation
- Medical subject headings
- Agnosia, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus plane blockProcedure or surgery
Ultrasound guided injection of local anesthetic between latissimus dorsi and serratus muscles at mid axillary line.
Axillary dissectionProcedure or surgery
Also called Axillary limphadenectomy
Axillary dissection is a surgical procedure that incises the axilla to identify, examine, or remove lymph nodes.
Intravenous sedationProcedure or surgery
Also called Sedation
Administration of sedatives thru an intravenous access to achieve relaxion and improve operative conditions.
| Study group | Role | What they receive |
|---|---|---|
| Serratus plane block plus sedation | Experimental | Serratus plane block plus intravenous sedation as anesthetic technique during axillary dissection procedure. Receives: Procedure: Serratus plane block; Procedure: Axillary dissection; Procedure: Intravenous sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who needed conversion to general anesthesia
Percentage of patients who needed conversion to general anesthesia. A percentage from 0 to 100%, where 0% means that no patient needs technique conversion to general anesthesia and 100% means that all patients need it.
Measured: Intraoperative
Secondary outcomes (7)
The 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire.
The QLQ-C30 is composed of multi-item scales and single-item measures. These include:
- A global health status / QoL scale
- Five functional scales (Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning)
- Three symptom scales (Fatigue, Nausea and vomiting, Pain)
- Six single items (Dyspnoea, Insomnia, Appetite loss, Constipation, Diarrhoea, Financial difficulties) Each of the multi-item scales includes a different set of items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems . The scales are scored as described as described in EORTC QLQ-C30 Scoring Manual. 2001 EORTC, Brussels.
Measured: Preoperative and in Postoperative day 30
QoR-40 questionnaire
Quality of Recovery - 40 Item questionnaire
QoR-40 score is a score developed to estimate the quality of recovery after anesthesia. It consists of a 40-item questionnaire with items on a five- point Likert scale (for positive items, 1 'none of the time' to 5 'all of the time'; for negative items the scoring was reversed). It is scored as follows:
QoR-40 dimensions
- Emotional state (9-45)
- Physical comfort (12-60)
- Psychological support (7-35)
- Physical independence (5-25)
- Pain (7-35) Global QoR-40 (40-200)
Measured: Preoperative, First postoperative day visit and in Postoperative day 30
Surgeon satisfaction - 5 points Likert scale
A five points Likert scale will be applied to the main surgeon responsible for the operation.
The surgeon will be asked to fill out a Likert 5 points scale to access his opinion about the quality of anesthesia (extremely satisfied, satisfied, not satisfied or dissatisfied, dissatisfied, extremely dissatisfied).
Measured: Imediate postoperative period
Patient satisfaction - 5 points Likert scale
A five points Likert scale will be applied to the patient in the first postoperative day visit to access his opinion about the quality of the anesthesia (extremely satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, extremely dissatisfied).
Measured: First postoperative day visit
Numeric pain rating scale (0-10)
Eleven point numeric pain rating scale (0 means no pain and 10 means worst possible pain).
Measured: Preoperative, postoperative day 1 and 30
Analgesic requirement
All the anesthetics and analgesics used in intraoperative and postoperative period will be recorded. Doses will be recorded in database.
Measured: Intraoperative and postoperative day one (cumulative dose)
Number of lymph nodes extracted
Number of lymph nodes extracted according to anatomopathological report.
Measured: Postoperative day 30 (according to anatomopathological report)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start25 Sep 2018
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Daniele Theobald, MD, Principal investigator, National Cancer Institute of Brazil (INCA - Brazil)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740815
- Sponsor's protocol ID
- CAAE 89037818.0.0000.5274
- Status last verified
- Aug 2021
- First submitted
- 25 Jun 2018
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fecho K, Miller NR, Merritt SA, Klauber-Demore N, Hultman CS, Blau WS. Acute and persistent postoperative pain after breast surgery. Pain Med. 2009 May-Jun;10(4):708-15. doi: 10.1111/j.1526-4637.2009.00611.x. Epub 2009 Apr 22.
PubMed 19453965Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.
PubMed 21435953Stoffels I, Dissemond J, Korber A, Hillen U, Poeppel T, Schadendorf D, Klode J. Reliability and cost-effectiveness of sentinel lymph node excision under local anaesthesia versus general anaesthesia for malignant melanoma: a retrospective analysis in 300 patients with malignant melanoma AJCC Stages I and II. J Eur Acad Dermatol Venereol. 2011 Mar;25(3):306-10. doi: 10.1111/j.1468-3083.2010.03786.x.
PubMed 20626530Stoffels I, Dissemond J, Schulz A, Hillen U, Schadendorf D, Klode J. Reliability and cost-effectiveness of complete lymph node dissection under tumescent local anaesthesia vs. general anaesthesia: a retrospective analysis in patients with malignant melanoma AJCC stage III. J Eur Acad Dermatol Venereol. 2012 Feb;26(2):200-6. doi: 10.1111/j.1468-3083.2011.04036.x. Epub 2011 Mar 17.
PubMed 21414036Pawa A, Wight J, Onwochei DN, Vargulescu R, Reed I, Chrisman L, Pushpanathan E, Kothari A, El-Boghdadly K. Combined thoracic paravertebral and pectoral nerve blocks for breast surgery under sedation: a prospective observational case series. Anaesthesia. 2018 Apr;73(4):438-443. doi: 10.1111/anae.14213. Epub 2018 Jan 12.
PubMed 29327341Woodworth 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 28820803Kwekkeboom K. Postmastectomy pain syndromes. Cancer Nurs. 1996 Feb;19(1):37-43. doi: 10.1097/00002820-199602000-00005.
PubMed 8904385Vecht CJ, Van de Brand HJ, Wajer OJ. Post-axillary dissection pain in breast cancer due to a lesion of the intercostobrachial nerve. Pain. 1989 Aug;38(2):171-6. doi: 10.1016/0304-3959(89)90235-2.
PubMed 2780072Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
PubMed 22939099Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14.
PubMed 20947592Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
PubMed 23923989Lee TH, Marcantonio ER, Mangione CM, Thomas EJ, Polanczyk CA, Cook EF, Sugarbaker DJ, Donaldson MC, Poss R, Ho KK, Ludwig LE, Pedan A, Goldman L. Derivation and prospective validation of a simple index for prediction of cardiac risk of major noncardiac surgery. Circulation. 1999 Sep 7;100(10):1043-9. doi: 10.1161/01.cir.100.10.1043.
PubMed 10477528Jette M, Sidney K, Blumchen G. Metabolic equivalents (METS) in exercise testing, exercise prescription, and evaluation of functional capacity. Clin Cardiol. 1990 Aug;13(8):555-65. doi: 10.1002/clc.4960130809.
PubMed 2204507Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.
PubMed 7165009Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
PubMed 10740540
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Feasibility of Ultrasound Guided Serratus Plane Block Associated With Sedation as Anesthetic Technique in Axillary Dissection
- ClinicalTrials.gov ID
- NCT03740815
- Acronym / sponsor ID
- CAAE 89037818.0.0000.5274
- Conditions
- Anesthesia, Regional Anesthesia Morbidity, Axillary Metastases, Nerve Block, Analgesia, Skin Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 14 Nov 2018 (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.
INTRODUCTION: The axillary lymphadenectomy procedure is known to be associated with late postoperative complications, such as chronic pain and changes in shoulder mobility. Recently, several thoracic ultrasound guided interfascial blocks have been described, including serratus plane block. These blocks were associated with reduced postoperative pain scores in breast surgeries but were never evaluated in axillary dissection. The safety and feasibility of performing axillary dissection under local anesthesia and tumescent anesthesia associated with sedation has been demonstrated in case series, although it is not already the standard technique.
DISCUSSION: This project aims to investigate the feasibility of the serratus plane block associated with intra-venous sedation in a prospective case series including 15 patients submitted to axillary dissection, by scoring patient and surgeon satisfaction with the technique, pain, quality of life with EORTC QLQ-C30 questionnaire, and quality of recovery with QoR-40 questionnaire in the first 30 postoperative days.
Detailed description
This study is a prospective case series. All patients should go through a preoperative evaluation with an anesthesiologist. At that time the eligibility for the study will be evaluated and if the patient consent to participate in the study.
The following parameters shall be evaluated in the ambulatory evaluation:
- Age
- Anthropometric data (weight and height);
- Presence of comorbidities;
- Revised cardiac index (LEE);
- Estimation of functional capacity in metabolic equivalents (METs) by history;
- Performance Status by the scale of Eastern Cooperative Oncology Group (ECOG);
- Determination of the physical status by the American Society of Anesthesiologists (ASA) classification;
- QoR-40 recovery quality scale, validated for Brazilian Portuguese;
- Quality of life EORTC QLQ-C30 questionnaire, validated for Brazilian Portuguese.
During the anesthetic procedure, the following standard technique should be applied: peripheral venous access, dipyrone 30 mg/kg, antibiotic according to the institutional protocol, moderate sedation with intravenous propofol in continuous infusion in the absence of any contraindication. Midazolam will be used in case of contraindication to propofol or during the execution of the block according to preference of the researcher who will perform the block. Associated with propofol infusion, the alpha agonist dexmedetomidine may be used in continuous infusion associated with fentanyl, tramadol, dextroketamine, magnesium sulfate, dipyrone and tenoxicam, whose uses will be evaluated on a case-by-case basis and will be recorded in the database.
In case of conversion to general anesthesia, the airway control should be carried out preferably with laryngeal mask, with the orotracheal intubation as an alternative option. The maintenance of anesthesia will be in this case using propofol continuous infusion in the absence of contraindications, otherwise sevoflurane will be used. Postoperative nausea and vomiting prophylaxis will be done with four milligrams of dexamethasone and ondansetron.
Patients will be submitted serratus plane block according to the technique described in Blanco. The patients will be positioned in a supine position. The transducer of the ultrasound device is protected with sterile cover. The ultrasound probe is positioned in the mid clavicular region of the thoracic wall in a sagittal plane. Using a nether-lateral path with the probe, will be counted the ribs, until the fifth rib is identified in the mid axillary line. In this position, over the fifth rib, the latissimus dorsi muscle superficially and the serratus muscle deeper and lower can be easily observed. The identification of the thoracodorsal artery with use of doppler imaging assists in identifying the superficial plane to the serratus muscle. Once identified the structures, the needle is introduced in the plane of the transducer positioning its tip on the surface of the serratus muscle. Then 40 ml of solution with 1% lidocaine, adrenaline 1:200,000 and ropivacaine 0.5% are injected in patients above 50kg and 32ml of the same solution in patients with body weight between 40 and 50kg aiming to respect the maximum dose of local anesthetic recommended.
At the end of the surgical procedure the patient will be referred to the anesthetic recovery unit. The extension of the blockade will be then evaluated. They will be discharged to ward as soon as they get the discharge criteria.
The surgical time, time for execution of the blockage (counted from the placement of the sterile field until the removal of the needle), the surgical room time, estimated bleeding, presence of surgical complications or anesthetic and number of lymph nodes extracted will be registered. At the end of the surgery the surgeon will be asked to fill out a range of Likert 5 points on his opinion on the quality of anesthesia (extremely satisfied, satisfied, not satisfied or dissatisfied, dissatisfied, extremely dissatisfied) and to compare the quality of anesthesia with general anesthesia on a 3-point scale (indistinguishable from general anesthesia, sufficient to perform the procedure, extremely challenging/inadequate).
On the first day of postoperative the standard analgesia will be carried out with dipyrone 30 mg/kg IV every 4 hours, associated with tenoxicam 20mg every 12 hours. In case of contraindication to dipyrone, will be administered paracetamol 500 mg VO every 6 hours. As a rescue therapy the default option is tramadol 50mg IV up to every 4 hours (daily maximum dose of 300mg/day and morphine 4 mg each hour (in case of allergy or intolerance to tramadol and rescue the tramadol). If necessary more than 24 hours of hospitalization, postoperative analgesia will be performed as option of the assistant team. The use of postoperative painkillers will be recorded in the database.
All patients should be evaluated on the first postoperative day with record of the verbal numerical scale for the evaluation of pain at rest, cough and abduction of 90 Degrees of the member and the presence of adverse effects. They be asked to fill the scale of Likert of 5 points with his opinion on the quality of anesthesia (extremely satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, extremely dissatisfied) and the scale of recovery quality QoR-40. Between the twenty-eighth and the thirtieth-fifth postoperative day All patients will be reassessed, occasion where the scale of recovery quality QoR-40 and the scale of quality of life EORTC QLQ-C30, presence of surgical wound infection will be applied, cutaneous necrosis, seroma, lymphedema, lymphatic fistula and date of drain removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serratus plane block plus sedation | Experimental | Procedure: Serratus plane block, Procedure: Axillary dissection, Procedure: Intravenous sedationSerratus plane block plus intravenous sedation as anesthetic technique during axillary dissection procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergo axillary dissection due to metastatic skin or soft tissue cancer;
- ASA physical status classification between I and III;
- have signed the informed consent.
Key exclusion criteria (4 listed)
- weight less than 40 kilograms;
- tumor affecting topography to be blocked;
- presence of ulcerated lesion in the axilla;
- presence of 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 |
|---|---|---|
| Serratus plane blockUltrasound guided injection of local anesthetic between latissimus dorsi and serratus muscles at mid axillary line. | Procedure or surgery | Serratus plane block plus sedation |
| Axillary dissectionAlso: Axillary limphadenectomyAxillary dissection is a surgical procedure that incises the axilla to identify, examine, or remove lymph nodes. | Procedure or surgery | Serratus plane block plus sedation |
| Intravenous sedationAlso: SedationAdministration of sedatives thru an intravenous access to achieve relaxion and improve operative conditions. | Procedure or surgery | Serratus plane block plus sedation |
Primary outcome
Percentage of patients who needed conversion to general anesthesia
Time frame: Intraoperative
Percentage of patients who needed conversion to general anesthesia. A percentage from 0 to 100%, where 0% means that no patient needs technique conversion to general anesthesia and 100% means that all patients need it.
7 secondary outcomes
The 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire.
Time frame: Preoperative and in Postoperative day 30
QoR-40 questionnaire
Time frame: Preoperative, First postoperative day visit and in Postoperative day 30
Surgeon satisfaction - 5 points Likert scale
Time frame: Imediate postoperative period
Patient satisfaction - 5 points Likert scale
Time frame: First postoperative day visit
Numeric pain rating scale (0-10)
Time frame: Preoperative, postoperative day 1 and 30
Analgesic requirement
Time frame: Intraoperative and postoperative day one (cumulative dose)
Number of lymph nodes extracted
Time frame: Postoperative day 30 (according to anatomopathological report)
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 8 Apr 2022.
- Background: PubMed 19453965Fecho K, Miller NR, Merritt SA, Klauber-Demore N, Hultman CS, Blau WS. Acute and persistent postoperative pain after breast surgery. Pain Med. 2009 May-Jun;10(4):708-15. doi: 10.1111/j.1526-4637.2009.00611.x. Epub 2009 Apr 22.
- Background: PubMed 21435953Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.
- Background: PubMed 20626530Stoffels I, Dissemond J, Korber A, Hillen U, Poeppel T, Schadendorf D, Klode J. Reliability and cost-effectiveness of sentinel lymph node excision under local anaesthesia versus general anaesthesia for malignant melanoma: a retrospective analysis in 300 patients with malignant melanoma AJCC Stages I and II. J Eur Acad Dermatol Venereol. 2011 Mar;25(3):306-10. doi: 10.1111/j.1468-3083.2010.03786.x.
- Background: PubMed 21414036Stoffels I, Dissemond J, Schulz A, Hillen U, Schadendorf D, Klode J. Reliability and cost-effectiveness of complete lymph node dissection under tumescent local anaesthesia vs. general anaesthesia: a retrospective analysis in patients with malignant melanoma AJCC stage III. J Eur Acad Dermatol Venereol. 2012 Feb;26(2):200-6. doi: 10.1111/j.1468-3083.2011.04036.x. Epub 2011 Mar 17.
- Background: PubMed 29327341Pawa A, Wight J, Onwochei DN, Vargulescu R, Reed I, Chrisman L, Pushpanathan E, Kothari A, El-Boghdadly K. Combined thoracic paravertebral and pectoral nerve blocks for breast surgery under sedation: a prospective observational case series. Anaesthesia. 2018 Apr;73(4):438-443. doi: 10.1111/anae.14213. Epub 2018 Jan 12.
- 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 8904385Kwekkeboom K. Postmastectomy pain syndromes. Cancer Nurs. 1996 Feb;19(1):37-43. doi: 10.1097/00002820-199602000-00005.
- Background: PubMed 2780072Vecht CJ, Van de Brand HJ, Wajer OJ. Post-axillary dissection pain in breast cancer due to a lesion of the intercostobrachial nerve. Pain. 1989 Aug;38(2):171-6. doi: 10.1016/0304-3959(89)90235-2.
- Background: PubMed 22939099Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
- Background: PubMed 20947592Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14.
- Background: PubMed 23923989Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
- Background: PubMed 10477528Lee TH, Marcantonio ER, Mangione CM, Thomas EJ, Polanczyk CA, Cook EF, Sugarbaker DJ, Donaldson MC, Poss R, Ho KK, Ludwig LE, Pedan A, Goldman L. Derivation and prospective validation of a simple index for prediction of cardiac risk of major noncardiac surgery. Circulation. 1999 Sep 7;100(10):1043-9. doi: 10.1161/01.cir.100.10.1043.
- EORTC QLQ-C30 Scoring Manual. 2001 EORTC, Brussels. ISBN 2-9300 64-22-6.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Daniele Theobald, MD principal investigator
National Cancer Institute of Brazil (INCA - Brazil)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus plane block, Axillary dissection and Intravenous sedation in people with Anesthesia and Regional Anesthesia Morbidity, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
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 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 8 Apr 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 Brazil. 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?
Percentage of patients who needed conversion to general anesthesia (time frame: Intraoperative). 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 NCT03740815, which also lists 18 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 8 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.