Pain, PostoperativePhase 4NCT02672813
Ultrasound Guided Pectoral Nerve I and II Blocks in Multimodal Analgesia for Breast Surgery
A Phase 4 study testing Pectoral nerve I and II block in people with Pain, Postoperative, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
The primary objective of this study is to access the effect of Pectoral nerve I and II blocks in breast surgery as measured by consumption of postoperative morphine or its equivalent. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Pectoral nerve I and II block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNepal
- Study dates
- Jul 2015to Sep 2016
- Phase
- Phase 4
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist ( ASA) Physical Status I, II
- Age between 16-65 Years
- Patients Undergoing breast surgery
Who cannot join
- Patient refusal
- Local infection
- Known hypersensitivity or any contraindications to study medication
- History of chronic pain
- Psychiatric illness
- Bilateral breast surgery
- Weight < 40 kg and > 100 kg
Trial locations and contacts
1 site in 1 country.
Krishna Pokharel, MD contact
Nepal1 site, 1 recruiting
- Recruiting
BP Koirala Institute of Health Sciences
Dharān, Sunsari, 56700
Anuranjan Ghimire, MBBS, 09779841551123, anuranjanghimire2@gmail.com
Krishna Pokharel, MD, 09779841986321
About this study
Official title: Ultrasound Guided Pectoral Nerve I and II Blocks in Multimodal Analgesia for Breast Surgery: A Randomized Single Blinded Control Trial
The primary objective of this study is to access the effect of Pectoral nerve I and II blocks in breast surgery as measured by consumption of postoperative morphine or its equivalent.
Read the detailed description
All patients in the study group and their relatives/attendants will be informed about the drugs, Pecs block and research methodology by the principal investigator during the pre-anaesthetic check up, in the evening before surgery. Informed and written consent will be obtained from the patient and/or his/her relatives. In order to assess pain, patient will be familiarized about the use of Numerical Rating Scale (NRS), in a language they can understand. (0 "as no pain at all" to 10 as "worst pain in life"). All of the patients will be premedicated with Tab diazepam 0.2mg/kg (not exceeding 10mg ) given orally night before surgery and in the morning of surgery.
On the day of surgery, after the patient arrives in the patient holding area in the operation theater, peripheral venous assess will be secured with 18G I.V cannula. In the operating room standard monitoring device will be attached to monitor Electrocardiograph ( ECG) , Pulse- oxymetry ( SpO2) , Non-invasive blood pressure ( NIBP), heart rate (HR) and End-tidal CO2 (Capnograph).
All patients will receive a standardized general anesthetic with multimodal analgesia. Preoxygenation will be done with 100% oxygen for three minutes. Induction will be done with loading dose of intravenous Fentanyl 1.5 mcg/kg and Propofol 1- 2 mg/kg and vecuronium 100mcg/kg. Airway will be secured by endotracheal intubation.
After induction of general anesthesia and before the start of surgery,ultrasound guided Pecs block will be performed by using 20-G Tuohy needle under all asceptic precautions. Images will be obtained using a Sonosite ultrasound machine. The probe will be placed at the mid clavicular level and angled inferolaterally,and then the axillary artery and vein will be located. The probe will then be moved laterally until pectoralis minor and serratus anterior are identified. The needle will be advanced in the tissue plane between Pectoralis major muscle (PMm) and Pectoralis minor muscle (Pmm) at the vicinity of pectoral branch of acromiothoracic artery and 10 ml of 0.25 % Ropivacine will be deposited. Similarly, 20ml of 0.25% Ropivacaine will be infiltrated in between Pmm and serratus anterior muscle at the level of third rib. (Blanco, R., Fajardo, M., Parras, M.T. 2006) Anesthesia will be maintained with isoflurane, oxygen, additional vecuronium and fentanyl. We will monitor Blood pressure, heart rate, SpO2, EtCO2, and ECG intraoperatively. During intraoperative period, 1gm of intravenous paracetomol will be given 15 minutes before the completion of surgery, over 15 minutes. Ondensatron (4mg IV) will be administered 15 minutes before the end of surgery as a prophylaxis for postoperative nausea and vomiting. Any episode of intraoperative hypotension (MAP lower than 65 mmHg) and bradycardia (heart rate < 50 bpm) will be treated with ephedrine 5 mg and atropine 0.4 mg IV respectively. On the completion of surgery,neuromuscular blockade will be reversed with 0.05 mg/kg of Neostigmine and 10mcg/kg of glycopyrrolate. The patient will then be extubated and transferred to postoperative recovery room.
In the postoperative recovery unit, blood pressure, pulse rate and oxygen saturation will be monitored for two hours. Assesment of pain scores at rest, coughing and on shoulder abuction along with postoperative nausea and vomiting (PONV) will be done in the postoperative recovery unit mmediately after patient will be transferred. If the patient has NRS of >3/10 at rest, intravenous morphine 2mg will be administered. If the pain is still not controlled, additional morphine of 2 mg can be given at 10 minute interval. PONV will be assessed by a categorical scale from 0 to 2. Intravenous ondensatron 4mg will be given if PONV scale is ≥1. If this proves to be ineffective, metoclopramide 10 mg will be administered. This rescue analgesia and antiemetic regimen will be followed for next 24 hours of surgery.
The patient will be transferred to ward on intravenous Ketorolac 30 mg every 8 hour and Ondensatron 4mg 8 hourly for 24 hours.
NRS for pain will be assessed immediately in postoperative recovery room and then at 2,4,8,12 and 24 hours of initial assessment.(on transfer to recovery). NRS will be calculated as 0 being "no pain" and 10 being "worst pain". NRS will also be assessed during coughing and abduction of ipsilateral shoulder in the at 0,2,8,12 and 24 hours of surgery. Similarly sedation score is also assessed at 0.2.4,8,12,and 24 hours after surgery ( 0 indicates the time of transfer to recovery and 2,4,8,12, and 24 meaning the time interval after 0 hour)
- Conditions
- Pain, Postoperative
- Being tested
- Pectoral nerve I and II block
- Keywords
- Pectoral nerve I and II blocks, Breast surgery, Ropivacaine, Postoperative opioid consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectoral nerve I and II blockProcedure or surgery
Also called Pecs block
Under Ultrasound guidance, Pectoral nerve I and II block is given for every breast surgery by using 10 and 20 ml of 0.25% Ropivacaine respectively
| Study group | Role | What they receive |
|---|---|---|
| Pectoral Nerve I and II block | Experimental | Under Ultrasound guidance, Pectoral nerve I block is given for every breast surgery using 10ml of 0.25 % Ropivacaine ( without added preservatives). Similarly Pectoral nerve II block is also given using 20 ml of 0.25% Ropivacaine ( without added preservative) in same group of patient. Receives: Procedure: Pectoral nerve I and II block |
| No block | No intervention | Pectoral nerve block is not given in this group of patients undergoing breast surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Morphine consumption.
Total amount of Morphine or its equivalent consumed by the patient in 24 hours following surgery is recorded
Measured: 24h
Secondary outcomes (5)
Postoperative Numerical Rating scale (NRS) score for pain
NRS score for pain is used to assess the pain during rest , during coughing, and during abduction of ipsilateral shoulder within 24 hours following surgery at different time intervals
Measured: 24 h
Satisfaction level
Visual analog scale score for satisfaction level regarding the pain control after surgery is assessed at 24 hours of breast surgery
Measured: 24h
Nausea and Vomiting
Number of patients who experience nausea and/or vomiting will be noted during the study
Measured: 24h
Local Anesthetic toxicity
The occurrence of local anesthetic toxicity adverse reactions like pruritis, urticaria,headache, anxiety, confusion,tremors, tingling sensation, hypotension, cardiac arrhythmia, cardiac arrest, seizure will be noted and recorded during and after surgery.
Measured: 24h
sedation score
5 point sedation scale is used to asses sedation within 24 hours at different time intervals ; where 0= alert, 1= arouses to voice, 2= arouses with gentle tactile stimulation, 3= arouses with vigorous tactile stimulation and 4= lack of responsiveness
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anuranjan Ghimire, B.P. Koirala Institute of Health Sciences
- Investigators
- Krishna Pokharel, MD, Study director, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672813
- Sponsor's protocol ID
- IRC/521/015
- Status last verified
- Feb 2016
- First submitted
- 28 Jan 2016
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Pectoral Nerve I and II Blocks in Multimodal Analgesia for Breast Surgery: A Randomized Single Blinded Control Trial
- ClinicalTrials.gov ID
- NCT02672813
- Acronym / sponsor ID
- IRC/521/015
- Conditions
- Pain, Postoperative
- Keywords
- Pectoral nerve I and II blocks, Breast surgery, Ropivacaine, Postoperative opioid consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 3 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.
The primary objective of this study is to access the effect of Pectoral nerve I and II blocks in breast surgery as measured by consumption of postoperative morphine or its equivalent.
Detailed description
All patients in the study group and their relatives/attendants will be informed about the drugs, Pecs block and research methodology by the principal investigator during the pre-anaesthetic check up, in the evening before surgery. Informed and written consent will be obtained from the patient and/or his/her relatives. In order to assess pain, patient will be familiarized about the use of Numerical Rating Scale (NRS), in a language they can understand. (0 "as no pain at all" to 10 as "worst pain in life"). All of the patients will be premedicated with Tab diazepam 0.2mg/kg (not exceeding 10mg ) given orally night before surgery and in the morning of surgery.
On the day of surgery, after the patient arrives in the patient holding area in the operation theater, peripheral venous assess will be secured with 18G I.V cannula. In the operating room standard monitoring device will be attached to monitor Electrocardiograph ( ECG) , Pulse- oxymetry ( SpO2) , Non-invasive blood pressure ( NIBP), heart rate (HR) and End-tidal CO2 (Capnograph).
All patients will receive a standardized general anesthetic with multimodal analgesia. Preoxygenation will be done with 100% oxygen for three minutes. Induction will be done with loading dose of intravenous Fentanyl 1.5 mcg/kg and Propofol 1- 2 mg/kg and vecuronium 100mcg/kg. Airway will be secured by endotracheal intubation.
After induction of general anesthesia and before the start of surgery,ultrasound guided Pecs block will be performed by using 20-G Tuohy needle under all asceptic precautions. Images will be obtained using a Sonosite ultrasound machine. The probe will be placed at the mid clavicular level and angled inferolaterally,and then the axillary artery and vein will be located. The probe will then be moved laterally until pectoralis minor and serratus anterior are identified. The needle will be advanced in the tissue plane between Pectoralis major muscle (PMm) and Pectoralis minor muscle (Pmm) at the vicinity of pectoral branch of acromiothoracic artery and 10 ml of 0.25 % Ropivacine will be deposited. Similarly, 20ml of 0.25% Ropivacaine will be infiltrated in between Pmm and serratus anterior muscle at the level of third rib. (Blanco, R., Fajardo, M., Parras, M.T. 2006) Anesthesia will be maintained with isoflurane, oxygen, additional vecuronium and fentanyl. We will monitor Blood pressure, heart rate, SpO2, EtCO2, and ECG intraoperatively. During intraoperative period, 1gm of intravenous paracetomol will be given 15 minutes before the completion of surgery, over 15 minutes. Ondensatron (4mg IV) will be administered 15 minutes before the end of surgery as a prophylaxis for postoperative nausea and vomiting. Any episode of intraoperative hypotension (MAP lower than 65 mmHg) and bradycardia (heart rate < 50 bpm) will be treated with ephedrine 5 mg and atropine 0.4 mg IV respectively. On the completion of surgery,neuromuscular blockade will be reversed with 0.05 mg/kg of Neostigmine and 10mcg/kg of glycopyrrolate. The patient will then be extubated and transferred to postoperative recovery room.
In the postoperative recovery unit, blood pressure, pulse rate and oxygen saturation will be monitored for two hours. Assesment of pain scores at rest, coughing and on shoulder abuction along with postoperative nausea and vomiting (PONV) will be done in the postoperative recovery unit mmediately after patient will be transferred. If the patient has NRS of >3/10 at rest, intravenous morphine 2mg will be administered. If the pain is still not controlled, additional morphine of 2 mg can be given at 10 minute interval. PONV will be assessed by a categorical scale from 0 to 2. Intravenous ondensatron 4mg will be given if PONV scale is ≥1. If this proves to be ineffective, metoclopramide 10 mg will be administered. This rescue analgesia and antiemetic regimen will be followed for next 24 hours of surgery.
The patient will be transferred to ward on intravenous Ketorolac 30 mg every 8 hour and Ondensatron 4mg 8 hourly for 24 hours.
NRS for pain will be assessed immediately in postoperative recovery room and then at 2,4,8,12 and 24 hours of initial assessment.(on transfer to recovery). NRS will be calculated as 0 being "no pain" and 10 being "worst pain". NRS will also be assessed during coughing and abduction of ipsilateral shoulder in the at 0,2,8,12 and 24 hours of surgery. Similarly sedation score is also assessed at 0.2.4,8,12,and 24 hours after surgery ( 0 indicates the time of transfer to recovery and 2,4,8,12, and 24 meaning the time interval after 0 hour)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectoral Nerve I and II block | Experimental | Procedure: Pectoral nerve I and II blockUnder Ultrasound guidance, Pectoral nerve I block is given for every breast surgery using 10ml of 0.25 % Ropivacaine ( without added preservatives). Similarly Pectoral nerve II block is also given using 20 ml of 0.25% Ropivacaine ( without added preservative) in same group of patient. |
| No block | No intervention | –Pectoral nerve block is not given in this group of patients undergoing breast surgery |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist ( ASA) Physical Status I, II
- Age between 16-65 Years
- Patients Undergoing breast surgery
Key exclusion criteria (7 listed)
- Patient refusal
- Local infection
- Known hypersensitivity or any contraindications to study medication
- History of chronic pain
- Psychiatric illness
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 |
|---|---|---|
| Pectoral nerve I and II blockAlso: Pecs blockUnder Ultrasound guidance, Pectoral nerve I and II block is given for every breast surgery by using 10 and 20 ml of 0.25% Ropivacaine respectively | Procedure or surgery | Pectoral Nerve I and II block |
Primary outcome
Postoperative Morphine consumption.
Time frame: 24h
Total amount of Morphine or its equivalent consumed by the patient in 24 hours following surgery is recorded
5 secondary outcomes
Postoperative Numerical Rating scale (NRS) score for pain
Time frame: 24 h
Satisfaction level
Time frame: 24h
Nausea and Vomiting
Time frame: 24h
Local Anesthetic toxicity
Time frame: 24h
sedation score
Time frame: 24h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
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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.
Krishna Pokharel, MD contact
Krishna Pokharel, MD study director
B.P. Koirala Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pectoral nerve I and II block in people with Pain, Postoperative, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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 7 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 5 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 Nepal. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Anuranjan Ghimire, MBBS (09779841551123, anuranjanghimire2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Morphine consumption. (time frame: 24h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2016.