Breast CancerPhase 3NCT02620371
Efficacy of Ketamine Added to Local Anesthetic in Modified Pectoral Block for Management of Postoperative Pain
A Phase 3 study testing modified pectoral block in people with Breast Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to compare the analgesic efficacy and safety of local bupivacaine alone versus bupivacaine plus ketamine in ultrasound guided modified Pecs block in patients undergoing breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- modified pectoral block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2015to Mar 2016
- Phase
- Phase 3
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) class I-II
- Body weight of 50 - 90 kg
Who cannot join
- History of bleeding diathesis
- Relevant drug allergy, opioid dependence
- Morbid obesity, sepsis
- prior surgery in the supraclavicular, infraclavicular or axillary regions,
- Alcohol or drug abuse
- Those with psychiatric illnesses that would interfere with perception and assessment of pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Ketamine Added to Local Anesthetic in Modified Pectoral Block for Management of Postoperative Pain in Patients Undergoing Modified Radical Mastectomy
This study aims to compare the analgesic efficacy and safety of local bupivacaine alone versus bupivacaine plus ketamine in ultrasound guided modified Pecs block in patients undergoing breast cancer surgery.
Read the detailed description
This randomized Clinical trial was approved by the ethics committee of South Egypt Cancer Institute, Assuit University, Assuit, Egypt. Sixty patients aged 18 - 60 years, American Society of Anesthesiologists (ASA) class I-II, with body weight of 50 - 90 kg and arranged for modified radical mastectomy) were enrolled in this study. Patients with a history of bleeding diathesis, relevant drug allergy, opioid dependence, morbid obesity, sepsis, prior surgery in the supraclavicular, infraclavicular or axillary regions, alcohol or drug abuse and those with psychiatric illnesses that would interfere with perception and assessment of pain were excluded from the study.
Preoperatively, patients were taught how to evaluate their own pain intensity using the Visual Analog Scale (VAS), scored from 0-10 (where 0= no pain and 10=worst pain imaginable), and whenever (during the follow up period) VAS points to a value ≥ 3. Analgesia comprised PCA with an initial morphine bolus of 0.1mg/kg once pain expressed by the patient or if VAS ≥ 3 followed by 1mg boluses with a lockout period a 5 minute. The time to first request for analgesia and the total analgesic consumption in the first 24 hours were recorded.
On arrival to the operating room, an intravenous line was inserted. Monitoring included electrocardiography (ECG), non-invasive blood pressure (NIBP), arterial oxygen saturation (Sao2) and end-tidal carbon- dioxide were applied.
Anesthesia was induced for all participating patients with 2 μg/kg fentanyl, 2-3 mg/kg propofol and 1.5 mg/kg lidocaine. Endotracheal intubation was facilitated by 0.15 mg/kg cis-atracurium. Anesthesia was maintained by 1-1.5 MAC isoflurane in 50% oxygen / air mixture and 0.03 mg/kg cisatrcurium respectively in ventilation parameters to maintain on ETco2 of approximately 35- 40 mmHg. Ultrasound guided pecs block then performed
Patients were randomly assigned into 2 groups (using a randomization-computer program), 30 patients in each:
Group I (Bupivacaine group): patients were given ultrasound guided, modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the two pectoralis muscles on the interfascial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.
Group II (Bupivacaine + ketamine group) : patients were given ultrasound guided, modified Pecs block with 30 ml of 0.25% bupivacaine plus ketamine (1 mg/kg) divided into 10 ml injected between the two pectoralis muscles on the interfascial plane , and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.
Modified Pecs block was performed under general anesthesia, and 15 min. before skin incision. We performed the modified Pecs block or the " Pecs II block" by using a two needle approach instead of one. The first puncture is a Pecs I block with 10 ml of local anesthetic injected between the two pectoralis muscles, and the second puncture injects 20 ml of local anesthetic between the Pectoralis minor muscle and the serratus muscle. This breaks through the 'axillary door' and will reach the long thoracic nerve and reliably at least two intercostal nerves.
We used a broadband linear array probe, with an imaging depth of 3-4cm. starting from the lateral third of the clavicle and moving distally and laterally to the mid axillary line.
At the end of surgery, reversal of muscle relaxant was done using neostigmine (0.04 mg/kg) and atropine (0.01 mg/kg). After extubation; all patients were transmitted to post anesthesia care unit (PACU).
Each patient in both groups was followed up and assessed at baseline, 1h, 2h, 4h, 6h , 12h , 24h, 48h postoperatively for: Vital signs (The patients' heart rate, non invasive arterial blood pressure, respiratory rate and oxygen saturation), Post operative pain where the severity of pain was assessed using VAS score, the time to first request of rescue analgesia and total morphine consumption in the 48 hours.
Potential side effects, including, sedation by sedation score of 0-4 (0 = patient fully awake; 1 = patient somnolent and responsive to verbal commands; 2 = patient somnolent and responsive to tactile stimulation; and 3 = patient asleep and responsive to painful stimulation; 4 = not arousable), chest pain, nausea, vomiting (treated by IV boluses of metochlopromide 10 mg), and psychological complications (hallucination, delirium, dreams, nystagmus, dissociative effects) were also recorded.
- Conditions
- Breast Cancer
- Being tested
- modified pectoral block
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified pectoral blockProcedure or surgery
Also called pecs II block
Modified Pecs block was performed under general anesthesia, and 15 min. before skin incision. We performed the modified Pecs block or the " Pecs II block" by using a two needle approach instead of one. The first puncture is a Pecs I block with 10 ml of local anesthetic injected between the two pectoralis muscles, and the second puncture injects 20 ml of local anesthetic between the Pectoralis minor muscle and the serratus muscle. This breaks through the 'axillary door' and will reach the long thoracic nerve and reliably at least two intercostal nerves.
We used A high frequency linear US probe is used for this block. a broadband linear array probe, with an imaging depth of 3-4cm. starting from the lateral third of the clavicle and moving distally and laterally to the mid axillary line.
| Study group | Role | What they receive |
|---|---|---|
| (bupivacaine) | Placebo comparator | 30 patients were given preoperative ultrasound guided, modified pectoral block (pecs II block) with local anesthetic(0.25% bupivacaine) Receives: Procedure: modified pectoral block |
| (bupivacaine, ketamine) | Active comparator | 30 patients were given preoperative ultrasound guided, modified pectoral block (pecs II block) with local anesthetic(0.25% bupivacaine plus ketamine 1 mg/kg) . Receives: Procedure: modified pectoral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Total morphine consumption in mg in the first 48 hours postoperatively
Measured: first 48 hours postoperatively
Secondary outcomes (2)
first request of rescue analgesia
first request of analgesia in hours in the first 48 hrs postoperative
Measured: 48 hours postoperatively
the severity of pain was assessed using VAS score
he severity of pain was assessed using VAS score in 48 hours postoperative
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Adel El sherif, Assiut University
- Investigators
- UNVERSITY, Principal investigator, ASSUIT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620371
- Sponsor's protocol ID
- 226
- Status last verified
- Sep 2015
- First submitted
- 27 Nov 2015
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Othman AH, El-Rahman AM, El Sherif F. Efficacy and Safety of Ketamine Added to Local Anesthetic in Modified Pectoral Block for Management of Postoperative Pain in Patients Undergoing Modified Radical Mastectomy. Pain Physician. 2016 Sep-Oct;19(7):485-94.
PubMed 27676665
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ketamine Added to Local Anesthetic in Modified Pectoral Block for Management of Postoperative Pain in Patients Undergoing Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT02620371
- Acronym / sponsor ID
- 226
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 3 Dec 2015 (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.
This study aims to compare the analgesic efficacy and safety of local bupivacaine alone versus bupivacaine plus ketamine in ultrasound guided modified Pecs block in patients undergoing breast cancer surgery.
Detailed description
This randomized Clinical trial was approved by the ethics committee of South Egypt Cancer Institute, Assuit University, Assuit, Egypt. Sixty patients aged 18 - 60 years, American Society of Anesthesiologists (ASA) class I-II, with body weight of 50 - 90 kg and arranged for modified radical mastectomy) were enrolled in this study. Patients with a history of bleeding diathesis, relevant drug allergy, opioid dependence, morbid obesity, sepsis, prior surgery in the supraclavicular, infraclavicular or axillary regions, alcohol or drug abuse and those with psychiatric illnesses that would interfere with perception and assessment of pain were excluded from the study.
Preoperatively, patients were taught how to evaluate their own pain intensity using the Visual Analog Scale (VAS), scored from 0-10 (where 0= no pain and 10=worst pain imaginable), and whenever (during the follow up period) VAS points to a value ≥ 3. Analgesia comprised PCA with an initial morphine bolus of 0.1mg/kg once pain expressed by the patient or if VAS ≥ 3 followed by 1mg boluses with a lockout period a 5 minute. The time to first request for analgesia and the total analgesic consumption in the first 24 hours were recorded.
On arrival to the operating room, an intravenous line was inserted. Monitoring included electrocardiography (ECG), non-invasive blood pressure (NIBP), arterial oxygen saturation (Sao2) and end-tidal carbon- dioxide were applied.
Anesthesia was induced for all participating patients with 2 μg/kg fentanyl, 2-3 mg/kg propofol and 1.5 mg/kg lidocaine. Endotracheal intubation was facilitated by 0.15 mg/kg cis-atracurium. Anesthesia was maintained by 1-1.5 MAC isoflurane in 50% oxygen / air mixture and 0.03 mg/kg cisatrcurium respectively in ventilation parameters to maintain on ETco2 of approximately 35- 40 mmHg. Ultrasound guided pecs block then performed
Patients were randomly assigned into 2 groups (using a randomization-computer program), 30 patients in each:
Group I (Bupivacaine group): patients were given ultrasound guided, modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the two pectoralis muscles on the interfascial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.
Group II (Bupivacaine + ketamine group) : patients were given ultrasound guided, modified Pecs block with 30 ml of 0.25% bupivacaine plus ketamine (1 mg/kg) divided into 10 ml injected between the two pectoralis muscles on the interfascial plane , and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.
Modified Pecs block was performed under general anesthesia, and 15 min. before skin incision. We performed the modified Pecs block or the " Pecs II block" by using a two needle approach instead of one. The first puncture is a Pecs I block with 10 ml of local anesthetic injected between the two pectoralis muscles, and the second puncture injects 20 ml of local anesthetic between the Pectoralis minor muscle and the serratus muscle. This breaks through the 'axillary door' and will reach the long thoracic nerve and reliably at least two intercostal nerves.
We used a broadband linear array probe, with an imaging depth of 3-4cm. starting from the lateral third of the clavicle and moving distally and laterally to the mid axillary line.
At the end of surgery, reversal of muscle relaxant was done using neostigmine (0.04 mg/kg) and atropine (0.01 mg/kg). After extubation; all patients were transmitted to post anesthesia care unit (PACU).
Each patient in both groups was followed up and assessed at baseline, 1h, 2h, 4h, 6h , 12h , 24h, 48h postoperatively for: Vital signs (The patients' heart rate, non invasive arterial blood pressure, respiratory rate and oxygen saturation), Post operative pain where the severity of pain was assessed using VAS score, the time to first request of rescue analgesia and total morphine consumption in the 48 hours.
Potential side effects, including, sedation by sedation score of 0-4 (0 = patient fully awake; 1 = patient somnolent and responsive to verbal commands; 2 = patient somnolent and responsive to tactile stimulation; and 3 = patient asleep and responsive to painful stimulation; 4 = not arousable), chest pain, nausea, vomiting (treated by IV boluses of metochlopromide 10 mg), and psychological complications (hallucination, delirium, dreams, nystagmus, dissociative effects) were also recorded.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (bupivacaine) | Placebo comparator | Procedure: modified pectoral block30 patients were given preoperative ultrasound guided, modified pectoral block (pecs II block) with local anesthetic(0.25% bupivacaine) |
| (bupivacaine, ketamine) | Active comparator | Procedure: modified pectoral block30 patients were given preoperative ultrasound guided, modified pectoral block (pecs II block) with local anesthetic(0.25% bupivacaine plus ketamine 1 mg/kg) . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) class I-II
- Body weight of 50 - 90 kg
Key exclusion criteria (6 listed)
- History of bleeding diathesis
- Relevant drug allergy, opioid dependence
- Morbid obesity, sepsis
- prior surgery in the supraclavicular, infraclavicular or axillary regions,
- Alcohol or drug abuse
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 |
|---|---|---|
| modified pectoral blockAlso: pecs II blockModified Pecs block was performed under general anesthesia, and 15 min. before skin incision. We performed the modified Pecs block or the " Pecs II block" by using a two needle approach instead of one. The first puncture is a Pecs I block with 10 ml of local anesthetic injected between the two pectoralis muscles, and the second puncture injects 20 ml of local anesthetic between the Pectoralis minor muscle and the serratus muscle. This breaks through the 'axillary door' and will reach the long thoracic nerve and reliably at least two intercostal nerves. We used A high frequency linear US probe is used for this block. a broadband linear array probe, with an imaging depth of 3-4cm. starting from the lateral third of the clavicle and moving distally and laterally to the mid axillary line. | Procedure or surgery | (bupivacaine), (bupivacaine, ketamine) |
Primary outcome
Total morphine consumption
Time frame: first 48 hours postoperatively
Total morphine consumption in mg in the first 48 hours postoperatively
2 secondary outcomes
first request of rescue analgesia
Time frame: 48 hours postoperatively
the severity of pain was assessed using VAS score
Time frame: 48 hours postoperatively
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 19 Apr 2016.
- Derived from this study: PubMed 27676665Othman AH, El-Rahman AM, El Sherif F. Efficacy and Safety of Ketamine Added to Local Anesthetic in Modified Pectoral Block for Management of Postoperative Pain in Patients Undergoing Modified Radical Mastectomy. Pain Physician. 2016 Sep-Oct;19(7):485-94.
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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.
UNVERSITY principal investigator
ASSUIT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing modified pectoral block in people with Breast Cancer, run by Assiut University at 1 site in Egypt.
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 19 Apr 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 Egypt. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total morphine consumption (time frame: first 48 hours postoperatively). 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 NCT02620371, 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 19 Apr 2016.