Postoperative PainPhase 3NCT04095455
The Effect Of Ultrasound-guided Modified Pectoral Nerves Block Versus Ketamine Plus Magnesium Infusion On Analgesic Profile In Breast Cancer Surgeries
A Phase 3 study testing pectoral nerves block group and Ketamine plus magnesium group in people with Postoperative Pain, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Background: Postoperative pain is one of the greatest patient concerns following surgery. However, general anesthesia cannot provide adequate postoperative pain control and the routine use of parenteral opioids aggravates postoperative sedation, nausea, emesis, impaired oxygenation and depressed ventilation. 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?
- pectoral nerves block group and Ketamine plus magnesium group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Nov 2017to 15 Apr 2021
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients with American society of Anesthesia classification(ASA) II physical status undergoing major breast cancer surgery with axillary evacuation under general anesthesia.
- Patients' age from18 to 65 Years.
- Body mass index (BMI) are from 20 to 40 kg/m2.
Who cannot join
- Pregnant patients
- Patients having sensitivity or contraindication to test drugs or regional anesthesia.
- severe respiratory or cardiac disorders.
- history of psychological disorder.
- chronic pain .
- significant liver or renal insufficiency. .
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute
Al Haram, Giza Governorate, 12555
Ahmed S Ahmed, MD, +20 01098426689, Dr_mido12@yahoo.com
About this study
Official title: The Effect Of Ultrasound-guided Modified Pectoral Nerves Block Versus Ketamine Plus Magnesium Infusion On Perioperative Analgesic Profile In Major Breast Cancer Surgeries: Randomized Controlled Study
Background: Postoperative pain is one of the greatest patient concerns following surgery. However, general anesthesia cannot provide adequate postoperative pain control and the routine use of parenteral opioids aggravates postoperative sedation, nausea, emesis, impaired oxygenation and depressed ventilation.
Hypothesis:
The investigators assume that both ultrasound guided Modified Pecs Block and combination of Ketamine and Magnesium sulphate infusion can achieve better analgesia in major breast cancer surgery in the form of reducing total amount of intraoperative fentanyl requirement and reducing postoperative morphine requirement and improvement of postoperative VAS scores both at rest and during shoulder movement so we plan this study to evaluate this assumption
Read the detailed description
Surgery on the chest wall is relatively common and can be associated with significant postoperative discomfort and pain; and one of the most common surgical sites on the chest wall is the breast, with the main indication for breast surgery being breast cancer. Breast cancer has continued to be the most common cancer in females, accounting for approximately 31% of all newly detected cancer cases in the female population, worldwide. (1, 2) Thousands of patients undergo surgery in the mammary and axillary regions every year, and these procedures tend to cause significant acute pain and may develop in to cases of chronic pain in 25-60% of cases. (3) Pain can be controlled using systemic opioids which have a respiratory depressant effect and causing nausea and vomiting.
Also can be controlled using epidural catheter that can cause haemodynamic instability, so we are searching about how to devrease pain with less complications.
- Conditions
- Postoperative Pain
- Being tested
- pectoral nerves block group, Ketamine plus magnesium group, Control group
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pectoral nerves block groupProcedure or surgery
ultrasound guided block of nerve supply of surgical site
Ketamine plus magnesium groupDrug
Patients received 40 mg/kg of magnesium sulphate infusion in 100cc normal saline, as a bolus dose, in addition to 0.2mg/kg of ketamine as a bolus dose, 15 min before the induction of general anesthesia. This was followed by intraoperative continuous infusion of 10 mg/kg/h of magnesium sulphate combined with infusion of 0.1mg/kg/h ketamine that was started before skin incision and continued until completion of skin closure via infusion pump (Atom Syringe Pump S-1235).
Control groupDrug
Normal saline infusion with similar rate and volume to KM infusion was used as a placebo.
| Study group | Role | What they receive |
|---|---|---|
| pectoral nerves block group | Active comparator | modified pectoral nerves block was performed on the side of surgery Receives: Procedure: pectoral nerves block group |
| Ktamine plus Magnesium group | Active comparator | Patients received 40 mg/kg of magnesium sulphate infusion in 100cc normal saline, as a bolus dose, in addition to 0.2mg/kg of ketamine as a bolus dose, 15 min before the induction of general anesthesia. This was followed by intraoperative continuous infusion of 10 mg/kg/h of magnesium sulphate combined with infusion of 0.1mg/kg/h ketamine that was started before skin incision and continued until completion of skin closure via infusion pump Receives: Drug: Ketamine plus magnesium group |
| Control Group | Active comparator | Normal saline infusion with similar rate and volume to KM infusion was used as a placebo Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
total morphine requirements
calculating the total dose of morphine consumed in postoperative analgesia
Measured: 24 hours postoperatively
Secondary outcomes (4)
fentanyl consumption
Total amount of fentanyl used by the anesthetic provider in the operating room
Measured: intraoperative period
Visual analogue scale score
assessement of Pain intensity in the PACU using the visual analogue scale (VAS) scores, both at rest and during shoulder movement, a scale from 0 to 10. scores towards 0 is reveal good analgesia.
Measured: immediately after recovery and then at 1, 4, 8, 12, and 24 hours postoperatively.
Sedation score
Sedation score assessement in Post Anesthesia Care Unit according to ramasy sedation score.(125) a scale from 1 to 6 with the preferred scores 2 or 3.
Measured: A sedation level recorded upon arrival to the PACU and at 1, 4, 8, 12, and 24 hours postoperatively.
Nausea and vomiting
assessement of Nausea and vomiting Scores using a four-point verbal scale (127).lower scores are preferred.
Measured: during the first post-operative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start12 Nov 2017
- Primary completion11 Mar 2021 (estimated)
- Study completion15 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salah Ahmed Abd Elgalil, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095455
- Sponsor's protocol ID
- N10-2017
- Status last verified
- Oct 2020
- First submitted
- 28 Jun 2019
- Last updated
- 27 Oct 2020
- 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 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Ultrasound-guided Modified Pectoral Nerves Block Versus Ketamine Plus Magnesium Infusion On Perioperative Analgesic Profile In Major Breast Cancer Surgeries: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04095455
- Acronym / sponsor ID
- N10-2017
- Conditions
- Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 12 Nov 2017 (actual)
- Primary completion
- 11 Mar 2021 (estimated)
- Study completion
- 15 Apr 2021 (estimated)
- First posted
- 19 Sep 2019 (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.
Background: Postoperative pain is one of the greatest patient concerns following surgery. However, general anesthesia cannot provide adequate postoperative pain control and the routine use of parenteral opioids aggravates postoperative sedation, nausea, emesis, impaired oxygenation and depressed ventilation.
Hypothesis:
The investigators assume that both ultrasound guided Modified Pecs Block and combination of Ketamine and Magnesium sulphate infusion can achieve better analgesia in major breast cancer surgery in the form of reducing total amount of intraoperative fentanyl requirement and reducing postoperative morphine requirement and improvement of postoperative VAS scores both at rest and during shoulder movement so we plan this study to evaluate this assumption
Detailed description
Surgery on the chest wall is relatively common and can be associated with significant postoperative discomfort and pain; and one of the most common surgical sites on the chest wall is the breast, with the main indication for breast surgery being breast cancer. Breast cancer has continued to be the most common cancer in females, accounting for approximately 31% of all newly detected cancer cases in the female population, worldwide. (1, 2) Thousands of patients undergo surgery in the mammary and axillary regions every year, and these procedures tend to cause significant acute pain and may develop in to cases of chronic pain in 25-60% of cases. (3) Pain can be controlled using systemic opioids which have a respiratory depressant effect and causing nausea and vomiting.
Also can be controlled using epidural catheter that can cause haemodynamic instability, so we are searching about how to devrease pain with less complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pectoral nerves block group | Active comparator | Procedure: pectoral nerves block groupmodified pectoral nerves block was performed on the side of surgery |
| Ktamine plus Magnesium group | Active comparator | Drug: Ketamine plus magnesium groupPatients received 40 mg/kg of magnesium sulphate infusion in 100cc normal saline, as a bolus dose, in addition to 0.2mg/kg of ketamine as a bolus dose, 15 min before the induction of general anesthesia. This was followed by intraoperative continuous infusion of 10 mg/kg/h of magnesium sulphate combined with infusion of 0.1mg/kg/h ketamine that was started before skin incision and continued until completion of skin closure via infusion pump |
| Control Group | Active comparator | Drug: Control groupNormal saline infusion with similar rate and volume to KM infusion was used as a placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female patients with American society of Anesthesia classification(ASA) II physical status undergoing major breast cancer surgery with axillary evacuation under general anesthesia.
- Patients' age from18 to 65 Years.
- Body mass index (BMI) are from 20 to 40 kg/m2.
Key exclusion criteria (6 listed)
- Pregnant patients
- Patients having sensitivity or contraindication to test drugs or regional anesthesia.
- severe respiratory or cardiac disorders.
- history of psychological disorder.
- chronic 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 |
|---|---|---|
| pectoral nerves block groupultrasound guided block of nerve supply of surgical site | Procedure or surgery | pectoral nerves block group |
| Ketamine plus magnesium groupPatients received 40 mg/kg of magnesium sulphate infusion in 100cc normal saline, as a bolus dose, in addition to 0.2mg/kg of ketamine as a bolus dose, 15 min before the induction of general anesthesia. This was followed by intraoperative continuous infusion of 10 mg/kg/h of magnesium sulphate combined with infusion of 0.1mg/kg/h ketamine that was started before skin incision and continued until completion of skin closure via infusion pump (Atom Syringe Pump S-1235). | Drug | Ktamine plus Magnesium group |
| Control groupNormal saline infusion with similar rate and volume to KM infusion was used as a placebo. | Drug | Control Group |
Primary outcome
total morphine requirements
Time frame: 24 hours postoperatively
calculating the total dose of morphine consumed in postoperative analgesia
4 secondary outcomes
fentanyl consumption
Time frame: intraoperative period
Visual analogue scale score
Time frame: immediately after recovery and then at 1, 4, 8, 12, and 24 hours postoperatively.
Sedation score
Time frame: A sedation level recorded upon arrival to the PACU and at 1, 4, 8, 12, and 24 hours postoperatively.
Nausea and vomiting
Time frame: during the first post-operative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
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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 Phase 3 study testing pectoral nerves block group and Ketamine plus magnesium group in people with Postoperative 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 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: status not confirmed, as of the sponsor's last update on 27 Oct 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total morphine requirements (time frame: 24 hours postoperatively). 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 27 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.