Condition or disease | Intervention/treatment | Phase |
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Postoperative Pain | Drug: sevoflurane and fentanil Drug: sevoflurane and fentanil plus PECS II block | Phase 4 |
The advent of ultrasound made possible greater safety and the creation of new peripheral blocks that aim to reduce the morbidity of the anesthetic technique on the cancer patient. Pectoral nerve block (PEC Block) is technically simple and easily reproducible. Inspired by the infraclavicular approach, it aims at the anesthesia of the pectoral, intercostobrachial, intercostal III-IV-V-VI nerves and the long thoracic nerve 8 being a safe, reproducible technique with little discomfort for the patients, with few complications and allowing a good control of acute pain.
The hypothesis is that the realization of pectoral nerve block provides a good alternative to epidural or paravertebral block with a lower risk for the patient and that is shown as an optimal anesthetic option with reduction in postoperative pain, anesthetic and opioid consumption. Main objective is the evaluation of postoperative pain through opioid consumption in the first 24 hours postoperatively.
Patients will undergo a prospective, randomized, single blind, placebo controlled study in which the examiners responsible for the postoperative evaluation will not know which of the two groups were randomly assigned: 40 patients in the Control and 40 patients in the PECS Group . Patients will be randomized through a list generated by www.randomizer.org into two groups.
Patients will receive standard monitoring, pre-anesthetic medication with midazolam 0.05 mg / kg EV. All patients will receive balanced general anesthesia with fentanyl 2 mcg / kg, lidocaine 2 mg / kg, propofol 1-2 mg / kg, cisatracurium 0.15 mg / kg or Rocuronium 0.6 mg / kg. The PECS II group will receive an injection of 20mL of 0.5% Ropivacaine between the serratus and the smaller pectoralis and 10mL of 0.5% ropivacaine between the pectoralis major and minor muscles with the aid of ultrasonography. Maintenance of anesthesia in the two groups: general anesthesia balanced with sevoflurane (with and fraction expired from 1 to 3%, to maintain BIS between 40 and 60). Prophylaxis for postoperative nausea and vomiting will be performed with slow intravenous administration following the anesthetic induction of Dexamethasone 4 mg, and at the end of the surgery slow intravenous administration of Ondansetron 4 mg. At the end of surgery, patients in both groups will receive Dipyrone 2 g and Parecoxib 40 mg. Patients will be evaluated in the postoperative times: T1: arrival at the PACU, T2: 3 hours postoperatively or discharge from the PACU), T3: 12 hours postoperative, T4: 24 hours postoperative.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Pectoralis and Serratus Nerve Blocks for Mastectomy: a Prospective, Randomized, Single-blind, Controlled Trial |
Actual Study Start Date : | July 1, 2018 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | July 2020 |
Arm | Intervention/treatment |
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Placebo Comparator: Placebo group
Patients in placebo group will receive general balanced inhaled anesthesia with sevoflurane and fentanil
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Drug: sevoflurane and fentanil
Patients will receive standard general anesthesia
Other Name: Standard general anesthesia
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Active Comparator: PECS II group
Patients in PECS II group will receive general balanced inhaled anesthesia with sevoflurane and fentanil
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Drug: sevoflurane and fentanil plus PECS II block
Pacients will receive standard general anesthesia with sevoflurane and fentanil associated to PECS II block
Other Name: Standard general anesthesia plus PECS II block
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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Fabricio T Mendonça, MD | +5561981882640 | correidofabricio@gmail.com |
Brazil | |
Hospital de Base do Distrito Federal | Recruiting |
Brasilia, DF, Brazil, 70680250 | |
Contact: Jamil Elias, MD 556133151588 uamphbdf@gmail.com | |
Contact: Viviane Rezende, MD 556133151331 vrezende@icab.med.br |
Principal Investigator: | Fabricio T Mendonça, MD | Hospital de Base do Distrito Federal |
Tracking Information | |||||
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First Submitted Date ICMJE | May 25, 2019 | ||||
First Posted Date ICMJE | May 29, 2019 | ||||
Last Update Posted Date | May 31, 2019 | ||||
Actual Study Start Date ICMJE | July 1, 2018 | ||||
Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Pain Scores on the Visual Analogue Scale [ Time Frame: Within the first 24 hours after surgery ] Quantify pain by Visual Analogue Scale (VAS, ranging from 0 to 10 cm, zero being found when the patient is no pain and ten, with maximum or un bearable pain
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Pectoralis and Serratus Nerve Blocks for Mastectomy: a Prospective, Randomized, Single-blind Trial | ||||
Official Title ICMJE | Pectoralis and Serratus Nerve Blocks for Mastectomy: a Prospective, Randomized, Single-blind, Controlled Trial | ||||
Brief Summary | Pectoral nerve block provides a good alternative to epidural or paravertebral block with a lower risk for the patient and that is shown as an optimal anesthetic option with reduction in postoperative pain, anesthetic and opioid consumption. The main objective of this study is to evaluate the quality of the perioperative analgesia of the PECS block in patients electively escalated for the accomplishment of mastectomy under general anesthesia. | ||||
Detailed Description |
The advent of ultrasound made possible greater safety and the creation of new peripheral blocks that aim to reduce the morbidity of the anesthetic technique on the cancer patient. Pectoral nerve block (PEC Block) is technically simple and easily reproducible. Inspired by the infraclavicular approach, it aims at the anesthesia of the pectoral, intercostobrachial, intercostal III-IV-V-VI nerves and the long thoracic nerve 8 being a safe, reproducible technique with little discomfort for the patients, with few complications and allowing a good control of acute pain. The hypothesis is that the realization of pectoral nerve block provides a good alternative to epidural or paravertebral block with a lower risk for the patient and that is shown as an optimal anesthetic option with reduction in postoperative pain, anesthetic and opioid consumption. Main objective is the evaluation of postoperative pain through opioid consumption in the first 24 hours postoperatively. Patients will undergo a prospective, randomized, single blind, placebo controlled study in which the examiners responsible for the postoperative evaluation will not know which of the two groups were randomly assigned: 40 patients in the Control and 40 patients in the PECS Group . Patients will be randomized through a list generated by www.randomizer.org into two groups. Patients will receive standard monitoring, pre-anesthetic medication with midazolam 0.05 mg / kg EV. All patients will receive balanced general anesthesia with fentanyl 2 mcg / kg, lidocaine 2 mg / kg, propofol 1-2 mg / kg, cisatracurium 0.15 mg / kg or Rocuronium 0.6 mg / kg. The PECS II group will receive an injection of 20mL of 0.5% Ropivacaine between the serratus and the smaller pectoralis and 10mL of 0.5% ropivacaine between the pectoralis major and minor muscles with the aid of ultrasonography. Maintenance of anesthesia in the two groups: general anesthesia balanced with sevoflurane (with and fraction expired from 1 to 3%, to maintain BIS between 40 and 60). Prophylaxis for postoperative nausea and vomiting will be performed with slow intravenous administration following the anesthetic induction of Dexamethasone 4 mg, and at the end of the surgery slow intravenous administration of Ondansetron 4 mg. At the end of surgery, patients in both groups will receive Dipyrone 2 g and Parecoxib 40 mg. Patients will be evaluated in the postoperative times: T1: arrival at the PACU, T2: 3 hours postoperatively or discharge from the PACU), T3: 12 hours postoperative, T4: 24 hours postoperative. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Postoperative Pain | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | O'Scanaill P, Keane S, Wall V, Flood G, Buggy DJ. Single-shot pectoral plane (PECs I and PECs II) blocks versus continuous local anaesthetic infusion analgesia or both after non-ambulatory breast-cancer surgery: a prospective, randomised, double-blind trial. Br J Anaesth. 2018 Apr;120(4):846-853. doi: 10.1016/j.bja.2017.11.112. Epub 2018 Feb 14. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
80 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 2020 | ||||
Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Brazil | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03966326 | ||||
Other Study ID Numbers ICMJE | PECS II block | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Fabricio Tavares Mendonca, Hospital de Base | ||||
Study Sponsor ICMJE | Hospital de Base | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Hospital de Base | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |