Postoperative PainNCT03899545
Serratus Plane Plus Pectoral I Block Versus Serratus Plane Block for Perioperative Analgesia in Breast Cancer Surgery
A study testing Serratus Plane Block and Serratus Plane Block plus Pectoral I Block in people with Postoperative Pain and Postoperative Nausea, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer is the most common malignancy in women at worldwide. Even a minor breast surgery can cause significant postoperative pain (PP) (1). PP could be converted into chronic pain in 25-40% of cases. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea, Patient Satisfaction
- What is being tested?
- Serratus Plane Block and Serratus Plane Block plus Pectoral I Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2019to 20 Sep 2019
- 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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-2-3
- Patients scheduled for elective surgery
Who cannot join
- Previous neurological disease symptom (TIA, syncope, dementia, etc.)
- Allergy to drugs
- Major cardiac disease
- Renal failure
- Psychiatric disease
- Patients who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Serratus Plane Plus Pectoral I Block Provide Better Perioperative Analgesia in Ambulatory Breast Cancer Surgery When Compared to Serratus Plane Block Alone
Breast cancer is the most common malignancy in women at worldwide. Even a minor breast surgery can cause significant postoperative pain (PP) (1). PP could be converted into chronic pain in 25-40% of cases. Inadequate PP control is associated with increased morbidity, delay in wound healing, prolonged hospital stay, increased opioid use, increased side effects and high cost of care. For these reasons, regional anesthetic techniques are recommended for effective PP management. Some of recent studies suggest that ultrasound-guided pectoral I (PI), pectoral II (PII) and serratus plan block (SPB) may be an alternative to thoracic epidural analgesia and paravertebral block applications because of the ease of administration, low side effect profile and adequate analgesia in breast surgery. (2,3).
Read the detailed description
In breast surgeries, the serratus plane block has recently been described and rapidly became popular. The serratus plane block is called the modified pectoral II block. Local anesthetic drugs are injected onto the serratus muscle by targeting thoracodorsal nerve, thoracicus longus nerve, lateral and anterior branches of the T2-T9 intercostal nerves. In the pectoral I (Pecs I) block, the medial and lateral pectoral nerves of the brachial plexus are targeted. Additionally, Pecs I block can be effective for analgesia in axillary dissection. In the literature, there are studies comparing pectoral I + II blocks and serratus plane block in terms of analgesic efficacy in breast surgery. The aim of this study was to evaluate the postoperative analgesic efficiency of serratus plane block and serratus plan block plus pectoral I block combination.
Participans will be informed about the potential benefits and complications after the study protocol has been fully and thoroughly explained. After premedication with 0.03 mg / kg iv midazolam, participans will be noninvasively monitored by taking into the operating room (heart rate, blood pressure, pulse oximetry). Anesthesia induction will delivered with fentanyl 1mcg / kg, propofol 1.5-2 mg / kg and rocuronium 0.5 mg / kg. The maintenance of anesthesia will be achieved by infusion of sevoflurane 1-3% in 50% O2/50% medical air. The depth of anesthesia will be evaluated with bispectral index monitoring and will be kept between 40 and 60.. Thirty minutes before end of the surgery, all patients were intravenously administered 20 mg tenoxicam HCl and 1gr paracetamol.
SPB plus Pecs I block technique: Bupivacaine/lidocaine mixture will be injected onto the serratus muscle and injected between the pectoralis minor/pectoralis major muscles.
SPB technique: Bupivacaine/lidocaine mixture will be injected onto the serratus muscle.
After the surgery, 1 g paracetamol was intravenously administered once every 8 h. Postoperative pain was assessed using VAS (VAS 0 = no pain, VAS 10 = most severe pain ). Morphine 0.1mg / kg will be used as rescue analgesic drug.Duration at PACU was recorded right from 0 h. VAS scores at 0, 1,2, 6, 12 and 24 h were recorded. PONV was evaluated using a numeric ranking scale (0 = no PONV, 1 = mild nausea, 2 = severe nausea or vomiting once attack, and 3 = vomiting more than once attack). If PONV score was >2, the antiemetic metoclopramide Hcl 10mg was intravenously administered.
- Being tested
- Serratus Plane Block, Serratus Plane Block plus Pectoral I Block
- Keywords
- serratus plane block, pectoral I block, breast cancer surgery, perioperative analgesia
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Plane BlockOther
0.5 ml /kg Bupivacaine/lidocaine mixture will be injected onto the serratus muscle
Serratus Plane Block plus Pectoral I BlockOther
0.5 ml / kg %0.25 Bupivacaine/ %1 lidocaine mixture will be injected onto the serratus muscle and injected between the pectoralis minor/pectoralis major muscles.2/3 of the total drug will be applied for the serratus plane block and 1/3 of the total drug for the pectoral I block. If the total amount of the drug is less than 30 ml, it will be completed with isotonic saline to 30 ml.
| Study group | Role | What they receive |
|---|---|---|
| Serratus Plane Block | Experimental | Serratus plane block will be applied after induction of general anesthesia. Receives: Other: Serratus Plane Block |
| Serratus Plane Block plus Pectoral I block | Active comparator | Serratus plane plus pectoral I block will be applied after induction of general anesthesia. Receives: Other: Serratus Plane Block plus Pectoral I Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity score
Self reported pain intensity in the postoperative 0, 1,2,6,12 and 24 hour. Each item is scored 0-10 (0: no pain 10: pain as bad as can be)
Measured: 24 hour
Secondary outcomes (5)
İntraoperative fentanyl requirement
Total amount of fentanyl use
Measured: during surgery
time to first analgesic request
time to first analgesic use
Measured: 24 hour
Postoperative opioid consumption
If pain intensity score >4 morphine 0,1 mg/kg will be given to the patient. The total amount of morphine requirement will be recorded.
Measured: 24 hour
Postoperative nausea and vomiting
Nausea and vomiting intensity score measured by numeric rank score (0:no nausea and no vomiting, 1: have nausea, no vomiting, 2: once vomiting, 3: two or more vomiting).
Measured: 24 hour
Patient satisfaction: score
Will be scored between 1-5 (1- very bad 5-very good).
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start6 Apr 2019
- Primary completion5 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Yeşiltaş, Bezmialem Vakif University
- Investigators
- Serdar Yeşiltaş, MD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899545
- Sponsor's protocol ID
- 71306642-5/24
- Status last verified
- Feb 2020
- First submitted
- 31 Mar 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yesiltas S, Turkoz A, Calim M, Yilmaz S, Esen A, Daskaya H, Karaaslan K. Comparison of serratus plane block alone and in combination with pectoral type 1 block for breast cancer surgery: a randomized controlled study. Hippokratia. 2021 Jan-Mar;25(1):8-14.
PubMed 35221650
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Serratus Plane Plus Pectoral I Block Provide Better Perioperative Analgesia in Ambulatory Breast Cancer Surgery When Compared to Serratus Plane Block Alone
- ClinicalTrials.gov ID
- NCT03899545
- Acronym / sponsor ID
- 71306642-5/24
- Keywords
- serratus plane block, pectoral I block, breast cancer surgery, perioperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 6 Apr 2019 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 2 Apr 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.
Breast cancer is the most common malignancy in women at worldwide. Even a minor breast surgery can cause significant postoperative pain (PP) (1). PP could be converted into chronic pain in 25-40% of cases. Inadequate PP control is associated with increased morbidity, delay in wound healing, prolonged hospital stay, increased opioid use, increased side effects and high cost of care. For these reasons, regional anesthetic techniques are recommended for effective PP management. Some of recent studies suggest that ultrasound-guided pectoral I (PI), pectoral II (PII) and serratus plan block (SPB) may be an alternative to thoracic epidural analgesia and paravertebral block applications because of the ease of administration, low side effect profile and adequate analgesia in breast surgery. (2,3).
Detailed description
In breast surgeries, the serratus plane block has recently been described and rapidly became popular. The serratus plane block is called the modified pectoral II block. Local anesthetic drugs are injected onto the serratus muscle by targeting thoracodorsal nerve, thoracicus longus nerve, lateral and anterior branches of the T2-T9 intercostal nerves. In the pectoral I (Pecs I) block, the medial and lateral pectoral nerves of the brachial plexus are targeted. Additionally, Pecs I block can be effective for analgesia in axillary dissection. In the literature, there are studies comparing pectoral I + II blocks and serratus plane block in terms of analgesic efficacy in breast surgery. The aim of this study was to evaluate the postoperative analgesic efficiency of serratus plane block and serratus plan block plus pectoral I block combination.
Participans will be informed about the potential benefits and complications after the study protocol has been fully and thoroughly explained. After premedication with 0.03 mg / kg iv midazolam, participans will be noninvasively monitored by taking into the operating room (heart rate, blood pressure, pulse oximetry). Anesthesia induction will delivered with fentanyl 1mcg / kg, propofol 1.5-2 mg / kg and rocuronium 0.5 mg / kg. The maintenance of anesthesia will be achieved by infusion of sevoflurane 1-3% in 50% O2/50% medical air. The depth of anesthesia will be evaluated with bispectral index monitoring and will be kept between 40 and 60.. Thirty minutes before end of the surgery, all patients were intravenously administered 20 mg tenoxicam HCl and 1gr paracetamol.
SPB plus Pecs I block technique: Bupivacaine/lidocaine mixture will be injected onto the serratus muscle and injected between the pectoralis minor/pectoralis major muscles.
SPB technique: Bupivacaine/lidocaine mixture will be injected onto the serratus muscle.
After the surgery, 1 g paracetamol was intravenously administered once every 8 h. Postoperative pain was assessed using VAS (VAS 0 = no pain, VAS 10 = most severe pain ). Morphine 0.1mg / kg will be used as rescue analgesic drug.Duration at PACU was recorded right from 0 h. VAS scores at 0, 1,2, 6, 12 and 24 h were recorded. PONV was evaluated using a numeric ranking scale (0 = no PONV, 1 = mild nausea, 2 = severe nausea or vomiting once attack, and 3 = vomiting more than once attack). If PONV score was >2, the antiemetic metoclopramide Hcl 10mg was intravenously administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus Plane Block | Experimental | Other: Serratus Plane BlockSerratus plane block will be applied after induction of general anesthesia. |
| Serratus Plane Block plus Pectoral I block | Active comparator | Other: Serratus Plane Block plus Pectoral I BlockSerratus plane plus pectoral I block will be applied after induction of general anesthesia. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1-2-3
- Patients scheduled for elective surgery
Key exclusion criteria (6 listed)
- Previous neurological disease symptom (TIA, syncope, dementia, etc.)
- Allergy to drugs
- Major cardiac disease
- Renal failure
- Psychiatric disease
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 Block0.5 ml /kg Bupivacaine/lidocaine mixture will be injected onto the serratus muscle | Other | Serratus Plane Block |
| Serratus Plane Block plus Pectoral I Block0.5 ml / kg %0.25 Bupivacaine/ %1 lidocaine mixture will be injected onto the serratus muscle and injected between the pectoralis minor/pectoralis major muscles.2/3 of the total drug will be applied for the serratus plane block and 1/3 of the total drug for the pectoral I block. If the total amount of the drug is less than 30 ml, it will be completed with isotonic saline to 30 ml. | Other | Serratus Plane Block plus Pectoral I block |
Primary outcome
Pain intensity score
Time frame: 24 hour
Self reported pain intensity in the postoperative 0, 1,2,6,12 and 24 hour. Each item is scored 0-10 (0: no pain 10: pain as bad as can be)
5 secondary outcomes
İntraoperative fentanyl requirement
Time frame: during surgery
time to first analgesic request
Time frame: 24 hour
Postoperative opioid consumption
Time frame: 24 hour
Postoperative nausea and vomiting
Time frame: 24 hour
Patient satisfaction: score
Time frame: 24 hour
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 25 Feb 2020.
- Derived from this study: PubMed 35221650Yesiltas S, Turkoz A, Calim M, Yilmaz S, Esen A, Daskaya H, Karaaslan K. Comparison of serratus plane block alone and in combination with pectoral type 1 block for breast cancer surgery: a randomized controlled study. Hippokratia. 2021 Jan-Mar;25(1):8-14.
- 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.
Serdar Yeşiltaş, MD principal investigator
Bezmialem Vakif 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 Serratus Plane Block and Serratus Plane Block plus Pectoral I Block in people with Postoperative Pain and Postoperative Nausea, run by Bezmialem Vakif 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 2 inclusion and 6 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 25 Feb 2020. 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?
Pain intensity score (time frame: 24 hour). 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 NCT03899545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.