AnalgesiaPhase 2NCT04275661
Ketamine Versus Magnesium Sulphate as Adjuvants for ESPB in Breast Cancer Surgery
A Phase 2 study testing Ultrasound (US) bi-level erector spinae block, levobupivacaine and Ketamine in people with Analgesia and Breast Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
Our aim will be to compare the analgesic efficacy and safety of ketamine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Analgesia, Breast Cancer
- What is being tested?
- Ultrasound (US) bi-level erector spinae block, levobupivacaine and Ketamine
- 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
- 1 Aug 2020to 30 Apr 2022
- Phase
- Phase 2
- 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
- Age of 18 - 60 years.
- ASA grade I - II.
Who cannot join
- Patient refusal. known allergy to the study drugs skin infection at site of needle puncture significant organ dysfunction Coagulopathy drug or alcohol abuse psychiatric illness 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 Versus Magnesium Sulphate as Adjuvants to Levobupivacaine in Ultrasound (US) Bi-level Erector Spinae Block in Breast Cancer Surgery
Our aim will be to compare the analgesic efficacy and safety of ketamine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy.
Read the detailed description
The participating females will be randomly allocated using computer generated randomizer program (http://www.randomizer.org) into one of 3 groups.
Group (C) / (I): 20 patients (control group):
Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and T7.
Group (K) / (II): 20 patients (Ketamine group):
Patient will receive 20ml 0.25% levobupivacaine as above + 2 mg /kg ketamine.
Group (M) / (III): 20 patients (magnesium sulphate group):
Patient will receive 20ml 0.25% levobupivacaine as above + 2mg/kg MgSo4.
Study protocol:
Premedication will be given, after complete fasting hours after applying standard monitors (noninvasive blood pressure, pulse oximetery. ECG, temp, and capnography), an intravenous cannula will be placed and secured in the opposite side to surgery.
Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (lt. or Rt.) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth and seventh spinous process, then Trapezious m., Rhomboideus major muscle, and erector spinae muscle, are identified from surface, we will deposite 20 ml of 0.25% levobupivacairen into interfacial plane below erector spinae muscle.
General anesthesia will be induced with lμg/kg fentanyl, 2mg/kg propofol, 0.5 mg/kg atracurium inhalational anesthesia (isoflurane or sevoflurane)
1gm paracetamol after induction No other narcotic, analgesic or sedative will be administrated during operative period.
Standard monitor (MABP, HR , SaO2 \& EtCo2) will be observed and recorded every 30 min till end of surgery Post-operative ; the patient will be transferred to the post anesthesia care unit (PACU). In PACU the following data included heart rate, mean blood pressure, respiratory rate and oxygen saturation and VAS scores (at rest and after movement in the form of abduction of ipsilateral arm ) at baseline,2,4,6,12,24 and 48 hours post-operatively to evaluate acute pain will be observed and recorded. The attending anesthesiologist, surgeon and the data collecting personal will be unaware of the patient assignment.
Rescue post-operative analgesia in the form of morphine Patient controlled analgesia (PCA ) with an initial bolus of 0.1 mg/ kg morphine once pain is expressed followed by 1mg bolus with a locked period of 15 minutes with no back ground infusion allowed. The time to first request of analgesia and the total analgesic consumption in the 1st 48 hour will be observed and recorded. Postoperative adverse effects will be observed and treated
- Conditions
- Analgesia, Breast Cancer
- Being tested
- Ultrasound (US) bi-level erector spinae block, levobupivacaine, Ketamine, Magnesium Sulfate
- Medical subject headings
- Agnosia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound (US) bi-level erector spinae blockProcedure or surgery
nerve block
levobupivacaineDrug
20 ml 0.25% levobupivacaine injected into fascial plane deep to erector spinae muscle
KetamineDrug
2 mg /kg ketamine.injected into fascial plane deep to erector spinae muscle
Magnesium SulfateDrug
2mg/kg Magnesium Sulfate .injected into fascial plane deep to erector spinae muscle
| Study group | Role | What they receive |
|---|---|---|
| Group (C) (control group) | Placebo comparator | Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7. Receives: Procedure: Ultrasound (US) bi-level erector spinae block; Drug: levobupivacaine |
| Group (K) (Ketamine group) | Experimental | Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7+ 1 mg / kg ketamine at each level with total dose 2mg/kg Receives: Procedure: Ultrasound (US) bi-level erector spinae block; Drug: levobupivacaine; Drug: Ketamine |
| Group (M) (magnesium sulphate group) | Experimental | Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7+ 1 mg / kg MgSo4 at each level with total dose 2mg/kg Receives: Procedure: Ultrasound (US) bi-level erector spinae block; Drug: levobupivacaine; Drug: Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
total morphine consumption in first 48 hours
determine the analgesic effect of ketamine and magnesium sulphate in decreasing morphine consumption
Measured: 48 hours
time to first request of analgesia
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Aug 2020
- Primary completion1 Mar 2022
- Study completion30 Apr 2022
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 AnalgesiaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Rabiee Ali, Assiut University
- Investigators
- khaled fares, Study director, Assiut Universityhamdy abbas, Study director, Assiut Universityfatma adel, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275661
- Sponsor's protocol ID
- ESPB in breast cancer surgery
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2020
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Bi-level erector spinae plane block for the control of severe back pain related to vertebral metastasis. BMJ Case Rep. 2019 Jun 20;12(6):e228129. doi: 10.1136/bcr-2018-228129.
PubMed 31227568Kwon WJ, Bang SU, Sun WY. Erector Spinae Plane Block for Effective Analgesia after Total Mastectomy with Sentinel or Axillary Lymph Node Dissection: a Report of Three Cases. J Korean Med Sci. 2018 Nov 5;33(45):e291. doi: 10.3346/jkms.2018.33.e291. No abstract available.
PubMed 31044575Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
PubMed 29980005
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ketamine Versus Magnesium Sulphate as Adjuvants to Levobupivacaine in Ultrasound (US) Bi-level Erector Spinae Block in Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT04275661
- Acronym / sponsor ID
- ESPB in breast cancer surgery
- Conditions
- Analgesia, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 19 Feb 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.
Our aim will be to compare the analgesic efficacy and safety of ketamine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy.
Detailed description
The participating females will be randomly allocated using computer generated randomizer program (http://www.randomizer.org) into one of 3 groups.
Group (C) / (I): 20 patients (control group):
Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and T7.
Group (K) / (II): 20 patients (Ketamine group):
Patient will receive 20ml 0.25% levobupivacaine as above + 2 mg /kg ketamine.
Group (M) / (III): 20 patients (magnesium sulphate group):
Patient will receive 20ml 0.25% levobupivacaine as above + 2mg/kg MgSo4.
Study protocol:
Premedication will be given, after complete fasting hours after applying standard monitors (noninvasive blood pressure, pulse oximetery. ECG, temp, and capnography), an intravenous cannula will be placed and secured in the opposite side to surgery.
Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (lt. or Rt.) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth and seventh spinous process, then Trapezious m., Rhomboideus major muscle, and erector spinae muscle, are identified from surface, we will deposite 20 ml of 0.25% levobupivacairen into interfacial plane below erector spinae muscle.
General anesthesia will be induced with lμg/kg fentanyl, 2mg/kg propofol, 0.5 mg/kg atracurium inhalational anesthesia (isoflurane or sevoflurane)
1gm paracetamol after induction No other narcotic, analgesic or sedative will be administrated during operative period.
Standard monitor (MABP, HR , SaO2 \& EtCo2) will be observed and recorded every 30 min till end of surgery Post-operative ; the patient will be transferred to the post anesthesia care unit (PACU). In PACU the following data included heart rate, mean blood pressure, respiratory rate and oxygen saturation and VAS scores (at rest and after movement in the form of abduction of ipsilateral arm ) at baseline,2,4,6,12,24 and 48 hours post-operatively to evaluate acute pain will be observed and recorded. The attending anesthesiologist, surgeon and the data collecting personal will be unaware of the patient assignment.
Rescue post-operative analgesia in the form of morphine Patient controlled analgesia (PCA ) with an initial bolus of 0.1 mg/ kg morphine once pain is expressed followed by 1mg bolus with a locked period of 15 minutes with no back ground infusion allowed. The time to first request of analgesia and the total analgesic consumption in the 1st 48 hour will be observed and recorded. Postoperative adverse effects will be observed and treated
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (C) (control group) | Placebo comparator | Procedure: Ultrasound (US) bi-level erector spinae block, Drug: levobupivacainePatient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7. |
| Group (K) (Ketamine group) | Experimental | Procedure: Ultrasound (US) bi-level erector spinae block, Drug: levobupivacaine, Drug: KetaminePatient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7+ 1 mg / kg ketamine at each level with total dose 2mg/kg |
| Group (M) (magnesium sulphate group) | Experimental | Procedure: Ultrasound (US) bi-level erector spinae block, Drug: levobupivacaine, Drug: Magnesium SulfatePatient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7+ 1 mg / kg MgSo4 at each level with total dose 2mg/kg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age of 18 - 60 years.
- ASA grade I - II.
Key exclusion criteria (1 listed)
- Patient refusal. known allergy to the study drugs skin infection at site of needle puncture significant organ dysfunction Coagulopathy drug or alcohol abuse psychiatric illness that would interfere with perception and assessment of pain.
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 |
|---|---|---|
| Ultrasound (US) bi-level erector spinae blocknerve block | Procedure or surgery | Group (C) (control group), Group (K) (Ketamine group), Group (M) (magnesium sulphate group) |
| levobupivacaine20 ml 0.25% levobupivacaine injected into fascial plane deep to erector spinae muscle | Drug | Group (C) (control group), Group (K) (Ketamine group), Group (M) (magnesium sulphate group) |
| Ketamine2 mg /kg ketamine.injected into fascial plane deep to erector spinae muscle | Drug | Group (K) (Ketamine group) |
| Magnesium Sulfate2mg/kg Magnesium Sulfate .injected into fascial plane deep to erector spinae muscle | Drug | Group (M) (magnesium sulphate group) |
Primary outcome
total morphine consumption in first 48 hours
Time frame: 48 hours
determine the analgesic effect of ketamine and magnesium sulphate in decreasing morphine consumption
time to first request of analgesia
Time frame: 48 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 4 Feb 2026.
- Background: PubMed 31227568Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Bi-level erector spinae plane block for the control of severe back pain related to vertebral metastasis. BMJ Case Rep. 2019 Jun 20;12(6):e228129. doi: 10.1136/bcr-2018-228129.
- Background: PubMed 31044575Kwon WJ, Bang SU, Sun WY. Erector Spinae Plane Block for Effective Analgesia after Total Mastectomy with Sentinel or Axillary Lymph Node Dissection: a Report of Three Cases. J Korean Med Sci. 2018 Nov 5;33(45):e291. doi: 10.3346/jkms.2018.33.e291. No abstract available.
- Background: PubMed 29980005Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
Related trials for Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
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.
khaled fares study director
Assiut University
hamdy abbas study director
Assiut University
fatma adel study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ultrasound (US) bi-level erector spinae block, levobupivacaine and Ketamine in people with Analgesia and 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 1 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 4 Feb 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 in first 48 hours (time frame: 48 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 NCT04275661, 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 4 Feb 2026.