Breast CancerPhase 2/3NCT05727098
Dexmedetomedine and Ketamine in Erector Spinae Block for Postoperative Analgesia Following Mastectomy.
A Phase 2/3 study testing Bupivacaine Hydrochloride, Bupivacaine Hydrochloride and dexmedetomedine and Bupivacaine Hydrochloride and ketamine in people with Breast Cancer, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Persistent pain after breast cancer surgery is frequently observed in more than 60% of patients.The suboptimal management of perioperative pain can lead to the occurrence of persistent breast cancer pain syndrome and phantom breast pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bupivacaine Hydrochloride, Bupivacaine Hydrochloride and dexmedetomedine and Bupivacaine Hydrochloride and ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 30 Apr 2023
- Phase
- Phase 2/3
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or II .
- female aged between 18 to 65. Scheduled for elective modified radical mastectomy under general anesthesia.
Who cannot join
- Patient known to have allergy to any of the drugs used in the study.
- Infection at injection site.
- Coagulation disorders.
- severe heart ,liver or kidney disease.
- Unwillingness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Dexmedetomedine and Ketamine in Erector Spinae Plane Block for Postoperative Analgesia Following Modified Radical Mastectomy. A Prospective Randomized Controlled Study.
Persistent pain after breast cancer surgery is frequently observed in more than 60% of patients.The suboptimal management of perioperative pain can lead to the occurrence of persistent breast cancer pain syndrome and phantom breast pain. Dexmedetomidine, a novel α2-agonist with an eight-fold affinity for α2-adrenergic receptors (sedate and analgesic effects) as clonidine, while exerts much less α1-effects., has been found to significantly increase the duration of peripheral nerve blocks, with minimal systemic side effects.
Ketamine is a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptors. It is used for sedation, premedication, induction, and maintenance of general anesthesia. Central, regional, and local anesthetic and analgesic properties have been reported for ketamine. Both can be used through Erector spinae plane block for postoperative pain control.
Read the detailed description
Persistent pain after breast cancer surgery is frequently observed in more than 60% of patients.The suboptimal management of perioperative pain can lead to the occurrence of persistent breast cancer pain syndrome and phantom breast pain.
A systematic review and meta-analysis of experimental studies showed that the provision of effective analgesia reduces both the number and incidence of metastases in experimental cancer models . Pain may influence body homeostasis and cancer progression by pain-related immune suppression.
General anesthesia is the conventional, most frequently used anesthetic technique in breast cancer surgical interventions. Various regional anesthetic techniques have also been used; these include local wound infiltration, thoracic epidural anesthesia, paravertebral block (PVB), thoracic spinal anesthesia, and more recently, ultrasound-guided interfacial plane blocks such as pectoral nerve (PECS) blocks type 1 and 2 and the serratus plane block (SPB). Recently introduced erector spinae plane block (ESPB) requires less technical expertise (easy), and may be a safe alternative to PVB. ESP block is described for treating thoracic neuropathic pain with encouraging results. ESP is a potential space deep to erector spinae muscle (ES), where the injected local anaesthetic (LA) spreads cranio-caudally up to several levels as the ES fascia extends from nuchal fascia cranially to the sacrum caudally (C7-T2 cranially and L2-L3 caudally), The block covers somatic and visceral pain during breast surgery blocks by blocking ventral rami, dorsal rami of spinal nerves, and rami communicans that transmit sympathetic fibers.
There is another potentially beneficial effects of regional anaesthesia and analgesia on perioperative outcomes, these include decreased opioids consumption , lower rate of post-operative pulmonary complications, decreased post-operative nausea vomiting (PONV) and decreased duration of post-anaesthesia care unit stay. Regional anaesthesia has long-term oncological outcomes as it is considered protective for cancer recurrence by its indirect and direct antiproliferative effects.
Over recent years, the addition of multiple types of additives to local anesthetics has been reported to improve analgesic effect of peripheral nerve block and regional blocks Dexmedetomidine, a novel α2-agonist with an eight-fold affinity for α2-adrenergic receptors (sedate and analgesic effects) as clonidine, while exerts much less α1-effects., has been found to significantly increase the duration of peripheral nerve blocks, with minimal systemic side effects.
Ketamine is a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptors. It is used for sedation, premedication, induction, and maintenance of general anesthesia. Central, regional, and local anesthetic and analgesic properties have been reported for ketamine.
- Conditions
- Breast Cancer
- Being tested
- Bupivacaine Hydrochloride, Bupivacaine Hydrochloride and dexmedetomedine, Bupivacaine Hydrochloride and ketamine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
Also called local anesthetic
injection of Bupivacaine 0.25% in ESPB
Bupivacaine Hydrochloride and dexmedetomedineDrug
Also called local anesthetic and dexmedetomedine
injection of Bupivacaine 0.25% and dexmedetomedine in ESPB
Bupivacaine Hydrochloride and ketamineDrug
Also called local anesthetic and ketamine
injection of Bupivacaine 0.25% and ketamine in ESPB
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | Will receive ultrasound guided ESPB with 0,25% Bupivacaine . Receives: Drug: Bupivacaine Hydrochloride |
| Bupivacaine and dexmedetomedine | Active comparator | Will receive ultrasound guided ESPB with 0,25% Bupivacaine + Dexmedetomidine. Receives: Drug: Bupivacaine Hydrochloride and dexmedetomedine |
| Bupivacaine and Ketamine | Active comparator | will receive ultrasound guided ESPB with 0,25% Bupivacaine + Ketamine. Receives: Drug: Bupivacaine Hydrochloride and ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia request postoperative
the time of first rescue analgesia
Measured: 24 hours
Total opioid consumption
Total opioid consumption
Measured: 24 hours
Secondary outcomes (1)
Visual analogue scale.
Calculation of Visual analogue scale at rest and mouvement. It is 10 points scale from 0 to 10 where 0 represents no pain while 10 represents maximum pain
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 posted14 Feb 2023
- Study start1 Jan 2023
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Hanafy Shaker, National Cancer Institute, Egypt
- Investigators
- Ehab H Shaker, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727098
- Sponsor's protocol ID
- Erector block after mastectomy
- Status last verified
- Jun 2023
- First submitted
- 3 Feb 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After data publication upon request
Publications
Hasoon J, Urits I, Viswanath O, Dar B, Kaye AD. Erector Spinae Plane Block for the Treatment of Post Mastectomy Pain Syndrome. Cureus. 2021 Jan 12;13(1):e12656. doi: 10.7759/cureus.12656.
PubMed 33585141
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Dexmedetomedine and Ketamine in Erector Spinae Plane Block for Postoperative Analgesia Following Modified Radical Mastectomy. A Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05727098
- Acronym / sponsor ID
- Erector block after mastectomy
- Conditions
- Breast Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 14 Feb 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.
Persistent pain after breast cancer surgery is frequently observed in more than 60% of patients.The suboptimal management of perioperative pain can lead to the occurrence of persistent breast cancer pain syndrome and phantom breast pain. Dexmedetomidine, a novel α2-agonist with an eight-fold affinity for α2-adrenergic receptors (sedate and analgesic effects) as clonidine, while exerts much less α1-effects., has been found to significantly increase the duration of peripheral nerve blocks, with minimal systemic side effects.
Ketamine is a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptors. It is used for sedation, premedication, induction, and maintenance of general anesthesia. Central, regional, and local anesthetic and analgesic properties have been reported for ketamine. Both can be used through Erector spinae plane block for postoperative pain control.
Detailed description
Persistent pain after breast cancer surgery is frequently observed in more than 60% of patients.The suboptimal management of perioperative pain can lead to the occurrence of persistent breast cancer pain syndrome and phantom breast pain.
A systematic review and meta-analysis of experimental studies showed that the provision of effective analgesia reduces both the number and incidence of metastases in experimental cancer models . Pain may influence body homeostasis and cancer progression by pain-related immune suppression.
General anesthesia is the conventional, most frequently used anesthetic technique in breast cancer surgical interventions. Various regional anesthetic techniques have also been used; these include local wound infiltration, thoracic epidural anesthesia, paravertebral block (PVB), thoracic spinal anesthesia, and more recently, ultrasound-guided interfacial plane blocks such as pectoral nerve (PECS) blocks type 1 and 2 and the serratus plane block (SPB). Recently introduced erector spinae plane block (ESPB) requires less technical expertise (easy), and may be a safe alternative to PVB. ESP block is described for treating thoracic neuropathic pain with encouraging results. ESP is a potential space deep to erector spinae muscle (ES), where the injected local anaesthetic (LA) spreads cranio-caudally up to several levels as the ES fascia extends from nuchal fascia cranially to the sacrum caudally (C7-T2 cranially and L2-L3 caudally), The block covers somatic and visceral pain during breast surgery blocks by blocking ventral rami, dorsal rami of spinal nerves, and rami communicans that transmit sympathetic fibers.
There is another potentially beneficial effects of regional anaesthesia and analgesia on perioperative outcomes, these include decreased opioids consumption , lower rate of post-operative pulmonary complications, decreased post-operative nausea vomiting (PONV) and decreased duration of post-anaesthesia care unit stay. Regional anaesthesia has long-term oncological outcomes as it is considered protective for cancer recurrence by its indirect and direct antiproliferative effects.
Over recent years, the addition of multiple types of additives to local anesthetics has been reported to improve analgesic effect of peripheral nerve block and regional blocks Dexmedetomidine, a novel α2-agonist with an eight-fold affinity for α2-adrenergic receptors (sedate and analgesic effects) as clonidine, while exerts much less α1-effects., has been found to significantly increase the duration of peripheral nerve blocks, with minimal systemic side effects.
Ketamine is a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptors. It is used for sedation, premedication, induction, and maintenance of general anesthesia. Central, regional, and local anesthetic and analgesic properties have been reported for ketamine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: Bupivacaine HydrochlorideWill receive ultrasound guided ESPB with 0,25% Bupivacaine . |
| Bupivacaine and dexmedetomedine | Active comparator | Drug: Bupivacaine Hydrochloride and dexmedetomedineWill receive ultrasound guided ESPB with 0,25% Bupivacaine + Dexmedetomidine. |
| Bupivacaine and Ketamine | Active comparator | Drug: Bupivacaine Hydrochloride and ketaminewill receive ultrasound guided ESPB with 0,25% Bupivacaine + Ketamine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I or II .
- female aged between 18 to 65. Scheduled for elective modified radical mastectomy under general anesthesia.
Key exclusion criteria (5 listed)
- Patient known to have allergy to any of the drugs used in the study.
- Infection at injection site.
- Coagulation disorders.
- severe heart ,liver or kidney disease.
- Unwillingness.
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 |
|---|---|---|
| Bupivacaine HydrochlorideAlso: local anestheticinjection of Bupivacaine 0.25% in ESPB | Drug | Bupivacaine |
| Bupivacaine Hydrochloride and dexmedetomedineAlso: local anesthetic and dexmedetomedineinjection of Bupivacaine 0.25% and dexmedetomedine in ESPB | Drug | Bupivacaine and dexmedetomedine |
| Bupivacaine Hydrochloride and ketamineAlso: local anesthetic and ketamineinjection of Bupivacaine 0.25% and ketamine in ESPB | Drug | Bupivacaine and Ketamine |
Primary outcome
Time to first rescue analgesia request postoperative
Time frame: 24 hours
the time of first rescue analgesia
Total opioid consumption
Time frame: 24 hours
Total opioid consumption
1 secondary outcome
Visual analogue 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 8 Jun 2023.
- Results publication: PubMed 33585141Hasoon J, Urits I, Viswanath O, Dar B, Kaye AD. Erector Spinae Plane Block for the Treatment of Post Mastectomy Pain Syndrome. Cureus. 2021 Jan 12;13(1):e12656. doi: 10.7759/cureus.12656.
- Erector Spinae Plane Block for the Treatment of Post Mastectomy Pain SyndromeLink provided by the sponsor.
- Individual participant dataSharing planned: No. After data publication upon request
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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.
Ehab H Shaker, MD principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bupivacaine Hydrochloride, Bupivacaine Hydrochloride and dexmedetomedine and Bupivacaine Hydrochloride and ketamine in people with Breast Cancer, 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 2 inclusion and 5 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 8 Jun 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time to first rescue analgesia request postoperative (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?
On the ClinicalTrials.gov record for NCT05727098, 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 8 Jun 2023.