Postoperative PainNCT04544228
Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy
A study testing Serratus Anterior Plane Block Technique, General anesthesia and bupivacaine +ketamine in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to Investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in Ultrasound guided Serratus anterior plane block for patients undergoing Modified Radical Mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Serratus Anterior Plane Block Technique, General anesthesia and bupivacaine +ketamine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2020to 1 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ● Female patients
- Type of surgery; Modified Radical Mastectomy (MRM).
- Physical status ASA II, III.
- Age ≥ 21 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
Who cannot join
- ● Patients with Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
- History of psychological disorders and/or chronic pain.
- Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
- Infection of the skin at the site of needle puncture area
- Patient refusal.
- Severe respiratory or cardiac disorders.
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- Advanced liver or kidney disease.
- Pregnancy.
- Patient with surgery duration more than two hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effectiveness of Adding Ketamine or Neostigmine to Bupivacaine for Ultrasound Guided Serratus Anterior Plane Block in Modified Radical Mastectomy , Randomized Double Blinded Comparative Study.
The aim of this study is to Investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in Ultrasound guided Serratus anterior plane block for patients undergoing Modified Radical Mastectomy.
Read the detailed description
Breast cancer is the most common malignancy among females with incidence of 18,660 patients each year in Egypt. Modified Radical Mastectomy is considered the main surgical management for breast cancer accounting for 31% of all breast surgery cases.
Ultrasound guided Serratus anterior plane block provides analgesia for breast and lateral thoracic wall surgeries by blocking nerves that are located in a compartment between the serratus anterior and the latissimus dorsi muscles ( the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve and thoracodorsal nerve).
A previous study demonstrated the analgesic efficacy of ketamine in patients undergoing modified pectoral nerve block in breast cancer surgery as evidenced by prolonged time to first rescue analgesia and reduced total opioid consumption.
Neostigmine has been used as an additive to local anesthetics to prolong the analgesic effect. Although there is good evidence for a spinal action of neostigmine, its analgesic efficacy as an adjuvant to local anesthetic is still unclear.
The aim of this study is to Investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in Ultrasound guided Serratus anterior plane block for patients undergoing Modified Radical Mastectomy.
- Conditions
- Postoperative Pain
- Being tested
- Serratus Anterior Plane Block Technique, General anesthesia, bupivacaine +ketamine, bupivacaine + neostigmine, bupivacaine +saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Anterior Plane Block TechniqueProcedure or surgery
The patient will be placed in Lateral Decubitus with a surgical side upwards with arm abduction. A linear ultrasound transducer (6-13 MHz) will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, with the indicator oriented toward the operator's left. With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized, local infiltration of the skin and subcutaneous tissue will be applied by 2-3ml of lidocaine 2%. Then, using ultrasound guidance, A 38-mm 22-gauge regional block needle will be advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. The expecting depth for this block is 1-4 cm. After aspiration, injection 30ml local anesthetic mixture will be injected anteriorly to the rib and deep to the serratus anterior muscle.
General anesthesiaProcedure or surgery
Induction of general anaesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium.
Anaesthesia will be maintained with inhaled sevoflurane 2-2.5% in oxygen enriched air (FiO2=0.5). Maintenance doses of rocuronium 0.1 m\kg will be provided every 30 minutes.
The residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes.
bupivacaine +ketamineDrug
Also called ketamine
30 ml bupivacaine 0.25% + 1 ml ketamine (50mg) in Serratus Anterior Plane Block.
bupivacaine + neostigmineDrug
Also called neostigmine
30 ml bupivacaine 0.25% + 1 ml neostigmine (500 μg)in Serratus Anterior Plane Block.
bupivacaine +salineDrug
Also called saline
30 ml bupivacaine 0.25% + 1 ml normal saline in Serratus Anterior Plane Block.
| Study group | Role | What they receive |
|---|---|---|
| ketamine | Experimental | Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml ketamine Receives: Procedure: Serratus Anterior Plane Block Technique; Procedure: General anesthesia; Drug: bupivacaine +ketamine |
| Neostigmine | Experimental | Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml neostigmine Receives: Procedure: Serratus Anterior Plane Block Technique; Procedure: General anesthesia; Drug: bupivacaine + neostigmine |
| Control | Active comparator | Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml normal saline. Receives: Procedure: Serratus Anterior Plane Block Technique; Procedure: General anesthesia; Drug: bupivacaine +saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of first request of analgesia
it will be calculated from the time of complete injection of local anesthetics till the numerical rating scale (NRS) is ≥3.
Measured: 24 hours postoperative
Secondary outcomes (3)
The total amount of morphine consumption
Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Numeric Pain Rating Scale ≥ 3. The total amount of morphine given in 24 hours will be recorded for the three groups.
Measured: 24 hours postoperative
Total amount of intraoperative fentanyl.
Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
Measured: 2 hours
Numeric Pain Rating Scale
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start5 Sep 2020
- Primary completion20 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Cairo 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant M. Abdelhamid, Cairo University
- Investigators
- Bassant abdelhamid, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544228
- Sponsor's protocol ID
- MS-101-2020
- Status last verified
- Mar 2021
- First submitted
- 28 Aug 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
El Mourad MB, Amer AF. Effects of adding dexamethasone or ketamine to bupivacaine for ultrasound-guided thoracic paravertebral block in patients undergoing modified radical mastectomy: A prospective randomized controlled study. Indian J Anaesth. 2018 Apr;62(4):285-291. doi: 10.4103/ija.IJA_791_17.
PubMed 29720754Pandey V, Mohindra BK, Sodhi GS. Comparative evaluation of different doses of intrathecal neostigmine as an adjuvant to bupivacaine for postoperative analgesia. Anesth Essays Res. 2016 Sep-Dec;10(3):538-545. doi: 10.4103/0259-1162.180779.
PubMed 27746548Blanco 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 23923989
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Adding Ketamine or Neostigmine to Bupivacaine for Ultrasound Guided Serratus Anterior Plane Block in Modified Radical Mastectomy , Randomized Double Blinded Comparative Study.
- ClinicalTrials.gov ID
- NCT04544228
- Acronym / sponsor ID
- MS-101-2020
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Sep 2020 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 10 Sep 2020 (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.
The aim of this study is to Investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in Ultrasound guided Serratus anterior plane block for patients undergoing Modified Radical Mastectomy.
Detailed description
Breast cancer is the most common malignancy among females with incidence of 18,660 patients each year in Egypt. Modified Radical Mastectomy is considered the main surgical management for breast cancer accounting for 31% of all breast surgery cases.
Ultrasound guided Serratus anterior plane block provides analgesia for breast and lateral thoracic wall surgeries by blocking nerves that are located in a compartment between the serratus anterior and the latissimus dorsi muscles ( the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve and thoracodorsal nerve).
A previous study demonstrated the analgesic efficacy of ketamine in patients undergoing modified pectoral nerve block in breast cancer surgery as evidenced by prolonged time to first rescue analgesia and reduced total opioid consumption.
Neostigmine has been used as an additive to local anesthetics to prolong the analgesic effect. Although there is good evidence for a spinal action of neostigmine, its analgesic efficacy as an adjuvant to local anesthetic is still unclear.
The aim of this study is to Investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in Ultrasound guided Serratus anterior plane block for patients undergoing Modified Radical Mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ketamine | Experimental | Procedure: Serratus Anterior Plane Block Technique, Procedure: General anesthesia, Drug: bupivacaine +ketaminePatients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml ketamine |
| Neostigmine | Experimental | Procedure: Serratus Anterior Plane Block Technique, Procedure: General anesthesia, Drug: bupivacaine + neostigminePatients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml neostigmine |
| Control | Active comparator | Procedure: Serratus Anterior Plane Block Technique, Procedure: General anesthesia, Drug: bupivacaine +salinePatients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml normal saline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ● Female patients
Key exclusion criteria (9 listed)
- ● Patients with Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
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 Anterior Plane Block TechniqueThe patient will be placed in Lateral Decubitus with a surgical side upwards with arm abduction. A linear ultrasound transducer (6-13 MHz) will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, with the indicator oriented toward the operator's left. With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized, local infiltration of the skin and subcutaneous tissue will be applied by 2-3ml of lidocaine 2%. Then, using ultrasound guidance, A 38-mm 22-gauge regional block needle will be advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. The expecting depth for this block is 1-4 cm. After aspiration, injection 30ml local anesthetic mixture will be injected anteriorly to the rib and deep to the serratus anterior muscle. | Procedure or surgery | Control, Neostigmine, ketamine |
| General anesthesiaInduction of general anaesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium. Anaesthesia will be maintained with inhaled sevoflurane 2-2.5% in oxygen enriched air (FiO2=0.5). Maintenance doses of rocuronium 0.1 m\kg will be provided every 30 minutes. The residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes. | Procedure or surgery | Control, Neostigmine, ketamine |
| bupivacaine +ketamineAlso: ketamine30 ml bupivacaine 0.25% + 1 ml ketamine (50mg) in Serratus Anterior Plane Block. | Drug | ketamine |
| bupivacaine + neostigmineAlso: neostigmine30 ml bupivacaine 0.25% + 1 ml neostigmine (500 μg)in Serratus Anterior Plane Block. | Drug | Neostigmine |
| bupivacaine +salineAlso: saline30 ml bupivacaine 0.25% + 1 ml normal saline in Serratus Anterior Plane Block. | Drug | Control |
Primary outcome
Time of first request of analgesia
Time frame: 24 hours postoperative
it will be calculated from the time of complete injection of local anesthetics till the numerical rating scale (NRS) is ≥3.
3 secondary outcomes
The total amount of morphine consumption
Time frame: 24 hours postoperative
Total amount of intraoperative fentanyl.
Time frame: 2 hours
Numeric Pain Rating Scale
Time frame: 24 hours
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 3 Mar 2021.
- Background: PubMed 29720754El Mourad MB, Amer AF. Effects of adding dexamethasone or ketamine to bupivacaine for ultrasound-guided thoracic paravertebral block in patients undergoing modified radical mastectomy: A prospective randomized controlled study. Indian J Anaesth. 2018 Apr;62(4):285-291. doi: 10.4103/ija.IJA_791_17.
- Background: PubMed 27746548Pandey V, Mohindra BK, Sodhi GS. Comparative evaluation of different doses of intrathecal neostigmine as an adjuvant to bupivacaine for postoperative analgesia. Anesth Essays Res. 2016 Sep-Dec;10(3):538-545. doi: 10.4103/0259-1162.180779.
- 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.
- 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.
Bassant abdelhamid, M.D. principal investigator
Cairo 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 Anterior Plane Block Technique, General anesthesia and bupivacaine +ketamine in people with Postoperative Pain, run by Cairo 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 5 inclusion and 9 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 3 Mar 2021. 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. 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?
Time of first request of analgesia (time frame: 24 hours postoperative). 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 NCT04544228, which also lists 3 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 3 Mar 2021.