Post Operative PainNCT05775393
Effects of Adding Dexamethasone Plus Ketamine to Bupivacine in Serrtatus Plane Block
A study testing Serratus anterior plane block for MRM in people with Post Operative Pain, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This randomized, double-blind trial included 60 female patients undergoing modified radical mastectomy. The study carried out at National Cancer Institute, cairo university after approval of the local ethical committee. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Serratus anterior plane block for MRM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2022to 20 May 2023
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All female patient undergoing modified radical mastectomy
- Age from 20 to 60 years
- ASA physical status I,II and III class
Who cannot join
- Refusal for SAPB.
- Defective coagulation.
- Infection at the site of injection.
- History of allergy to the study drugs
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Fakher
Cairo, Matareya, 11756
Ahmed Fakher, +201097419966, ahmezfakhr66@gmail.com
About this study
Official title: Effects of Adding Dexamethasone Plus Ketamine to Bupivacaine for Ultrasound Guided Serratus Plane Block as Analgesia in Major Breast Surgery
This randomized, double-blind trial included 60 female patients undergoing modified radical mastectomy. The study carried out at National Cancer Institute, cairo university after approval of the local ethical committee.
The study aiming to compare the analgesic efficiency of adding dexamethasone or ketamine plus dexamethasone to bupivacaine in ultrasound-guided serratus anterior plane block (SAPB) performed with modified radical mastectomy surgery.
Read the detailed description
They will randomly assigned to two groups of 30 patients each, at 1:1 allocation ratio using computer-generated random numbers concealed in sealed opaque envelopes.
Group (A):
Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0 .25 % and dexamethasone 4 mg).
Group (B):
Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0.25% and dexamethasone 4mg with ketamine 50 mg).
All the medications were prepared by an anesthesiologist not participating in the study.
Preoperative visit :
All cases will be assessed for any hemodynamic abnormalities in the preoperative room. Patient will be informed about the purpose and the content of the study before surgery. An informed consent |will be obtained from the participants.
Anesthetic technique :
General anesthesia A uniform anesthetic technique was used in two groups, namely, after pre oxygenation with 100% oxygen for 3 mints, induction of anesthesia will be by IV propofol 2 mg/kg, fentanyl 200 μg and atracurium 0.5 mg/kg to facilitate endotracheal intubation.
Anesthesia will be maintained with isoflurane 1-2% in 50% air in oxygen mixtures. Intermittent dose of atracurium for muscle relaxation and fentanyl will be used if heart rate increased more than 20% of initial HR.
All patients will be mechanically ventilated to maintain end-tidal carbon dioxide tension around 35 mmHg.
After induction of general anesthesia, ultrasound-guided SAPB will be done. Technique of SAPB Patients will be placed in the lateral position with the diseased side up. A linear ultrasound transducer (10-12 MHz) is placed over the mid-clavicular region of the thoracic cage in a sagittal plane.
The fifth rib is identified in the mid-axillary line. The following muscles are identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior).
As an extra-reference point, the thoracodorsal artery is used to aid the identification of the plane superficial to the serratus muscle.
The needle (22G, 50-mm Tuohy needle) is introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle.
Under continuous ultrasound guidance, local anesthetic solution is injected and fanning of local anesthetic is observed.
All patients will be continuously monitored with 5 leads electrocardiogram (ECG), pulse oximetry, non-invasive blood pressure monitoring (NIBP), end-tidal CO2, and TOF.
Inhalation anesthetic will be discontinued at the end of surgery and neuromuscular blockade was reversed by IV injection of neostigmine 0.05 mg/kg with atropine 0.01 mg/kg after fulfilling the criteria for extubation. Patients were extubated and transferred to surgical ICU.
For postoperative pain management, all patients will receive intravenous (IV) paracetamol 1 gm every 6 hrs (Injectemol, Pharco B International, Pharma-tech) then morphine IV (2-4 mg) if required to keep VAS score less than 3.
Morphine consumption during the first 24 postoperative hours as a rescue drug was calculated.
Patients will be continuously monitored for heart rate, oxygen saturation and systemic blood pressure and we will record every 10 min for the initial 1 hr. of the blockade; every 30 mints for the next 2 hrs. And then 2 hourly for the next 12 hrs.
As soon as the patient is alert enough, VAS score of pain (10 mm vertical scale from 0 to 10 where zero means no pain and 10 is the worst pain) was recorded every 2 hrs.
Sedation was assessed using the observer's assessment of alertness/sedation (OAA/S) scale.
The scale was scored as a composite score ranging from 1 (deep sleep) to 5 (alert).
Signs of morphine side effects (nausea, vomiting, dizziness, an unusual pleasant feeling, sweating, headache, anxiety, and constipation) will be monitored.
In case of nausea and/or vomiting, 10 mg metoclopramide was given intravenously.
Signs of side effects of SAPB as dyspnea, chest pain in case of pneumothorax and signs of local anesthetic toxicity will be monitored as arrhythmias , convulsions and circulatory collapse
- Conditions
- Post Operative Pain
- Being tested
- Serratus anterior plane block for MRM
- Keywords
- Serratus ,analgesia ,ketamine
- 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 for MRMProcedure or surgery
They will randomly assigned to two groups of 30 patients each, at 1:1 allocation ratio using computer-generated random numbers concealed in sealed opaque envelopes.
Group (A):
Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0 .25 % and dexamethasone 4 mg).
Group (B):
Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0.25% and dexamethasone 4mg with ketamine 50 mg).
All the medications were prepared by an anesthesiologist not participating in the study.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Serratus anterior plane block using 30ml of (bupivacaine 0 .25 % and dexamethasone 4 mg) Receives: Procedure: Serratus anterior plane block for MRM |
| Group B | Experimental | Serratus anterior plane block using 30ml of (bupivacaine 0.25% and dexamethasone 4mg with ketamine 50 mg). Receives: Procedure: Serratus anterior plane block for MRM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post ooerative analgesia requirment
Total post-operative morphine consumption over the first 24 hours post-operative and difference between two groups.
Measured: 24 hours
Time of first analgesic request
The time to first request of analgesic postoperatively and difference between two groups.
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 posted20 Mar 2023
- Study start20 Feb 2022
- Primary completion20 Apr 2023 (estimated)
- Study completion20 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Fakher Mohamed Abdou, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775393
- Sponsor's protocol ID
- AP2202-30105
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding Dexamethasone Plus Ketamine to Bupivacaine for Ultrasound Guided Serratus Plane Block as Analgesia in Major Breast Surgery
- ClinicalTrials.gov ID
- NCT05775393
- Acronym / sponsor ID
- AP2202-30105
- Conditions
- Post Operative Pain
- Keywords
- Serratus ,analgesia ,ketamine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 20 Apr 2023 (estimated)
- Study completion
- 20 May 2023 (estimated)
- First posted
- 20 Mar 2023 (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.
This randomized, double-blind trial included 60 female patients undergoing modified radical mastectomy. The study carried out at National Cancer Institute, cairo university after approval of the local ethical committee.
The study aiming to compare the analgesic efficiency of adding dexamethasone or ketamine plus dexamethasone to bupivacaine in ultrasound-guided serratus anterior plane block (SAPB) performed with modified radical mastectomy surgery.
Detailed description
They will randomly assigned to two groups of 30 patients each, at 1:1 allocation ratio using computer-generated random numbers concealed in sealed opaque envelopes.
Group (A):
Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0 .25 % and dexamethasone 4 mg).
Group (B):
Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0.25% and dexamethasone 4mg with ketamine 50 mg).
All the medications were prepared by an anesthesiologist not participating in the study.
Preoperative visit :
All cases will be assessed for any hemodynamic abnormalities in the preoperative room. Patient will be informed about the purpose and the content of the study before surgery. An informed consent |will be obtained from the participants.
Anesthetic technique :
General anesthesia A uniform anesthetic technique was used in two groups, namely, after pre oxygenation with 100% oxygen for 3 mints, induction of anesthesia will be by IV propofol 2 mg/kg, fentanyl 200 μg and atracurium 0.5 mg/kg to facilitate endotracheal intubation.
Anesthesia will be maintained with isoflurane 1-2% in 50% air in oxygen mixtures. Intermittent dose of atracurium for muscle relaxation and fentanyl will be used if heart rate increased more than 20% of initial HR.
All patients will be mechanically ventilated to maintain end-tidal carbon dioxide tension around 35 mmHg.
After induction of general anesthesia, ultrasound-guided SAPB will be done. Technique of SAPB Patients will be placed in the lateral position with the diseased side up. A linear ultrasound transducer (10-12 MHz) is placed over the mid-clavicular region of the thoracic cage in a sagittal plane.
The fifth rib is identified in the mid-axillary line. The following muscles are identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior).
As an extra-reference point, the thoracodorsal artery is used to aid the identification of the plane superficial to the serratus muscle.
The needle (22G, 50-mm Tuohy needle) is introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle.
Under continuous ultrasound guidance, local anesthetic solution is injected and fanning of local anesthetic is observed.
All patients will be continuously monitored with 5 leads electrocardiogram (ECG), pulse oximetry, non-invasive blood pressure monitoring (NIBP), end-tidal CO2, and TOF.
Inhalation anesthetic will be discontinued at the end of surgery and neuromuscular blockade was reversed by IV injection of neostigmine 0.05 mg/kg with atropine 0.01 mg/kg after fulfilling the criteria for extubation. Patients were extubated and transferred to surgical ICU.
For postoperative pain management, all patients will receive intravenous (IV) paracetamol 1 gm every 6 hrs (Injectemol, Pharco B International, Pharma-tech) then morphine IV (2-4 mg) if required to keep VAS score less than 3.
Morphine consumption during the first 24 postoperative hours as a rescue drug was calculated.
Patients will be continuously monitored for heart rate, oxygen saturation and systemic blood pressure and we will record every 10 min for the initial 1 hr. of the blockade; every 30 mints for the next 2 hrs. And then 2 hourly for the next 12 hrs.
As soon as the patient is alert enough, VAS score of pain (10 mm vertical scale from 0 to 10 where zero means no pain and 10 is the worst pain) was recorded every 2 hrs.
Sedation was assessed using the observer's assessment of alertness/sedation (OAA/S) scale.
The scale was scored as a composite score ranging from 1 (deep sleep) to 5 (alert).
Signs of morphine side effects (nausea, vomiting, dizziness, an unusual pleasant feeling, sweating, headache, anxiety, and constipation) will be monitored.
In case of nausea and/or vomiting, 10 mg metoclopramide was given intravenously.
Signs of side effects of SAPB as dyspnea, chest pain in case of pneumothorax and signs of local anesthetic toxicity will be monitored as arrhythmias , convulsions and circulatory collapse
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Serratus anterior plane block for MRMSerratus anterior plane block using 30ml of (bupivacaine 0 .25 % and dexamethasone 4 mg) |
| Group B | Experimental | Procedure: Serratus anterior plane block for MRMSerratus anterior plane block using 30ml of (bupivacaine 0.25% and dexamethasone 4mg with ketamine 50 mg). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All female patient undergoing modified radical mastectomy
- Age from 20 to 60 years
- ASA physical status I,II and III class
Key exclusion criteria (4 listed)
- Refusal for SAPB.
- Defective coagulation.
- Infection at the site of injection.
- History of allergy to the study drugs
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 for MRMThey will randomly assigned to two groups of 30 patients each, at 1:1 allocation ratio using computer-generated random numbers concealed in sealed opaque envelopes. Group (A): Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0 .25 % and dexamethasone 4 mg). Group (B): Patients will receive ultrasound-guided serratus anterior block using 30ml of (bupivacaine 0.25% and dexamethasone 4mg with ketamine 50 mg). All the medications were prepared by an anesthesiologist not participating in the study. | Procedure or surgery | Group A, Group B |
Primary outcome
Post ooerative analgesia requirment
Time frame: 24 hours
Total post-operative morphine consumption over the first 24 hours post-operative and difference between two groups.
Time of first analgesic request
Time frame: 24 hours
The time to first request of analgesic postoperatively and difference between two groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
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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.
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 for MRM in people with Post Operative Pain, run by National Cancer Institute, Egypt 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 3 inclusion and 4 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 20 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Fakher (+201097419966, ahmezfakhr66@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post ooerative analgesia requirment (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 20 Mar 2023.