Post Operative PainPhase 3NCT05802979
Ketamine Versus Neostigmine as Adjuvants to Bupivacaine During Ultrasound-guided Serratus Anterior Block
A Phase 3 study testing Adjuvants, Anesthesia in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study is designed to investigate the analgesic efficacy of ketamine compared to neostigmine as adjuvants to LA in ultrasound guided Serratus Anterior Plane Block (SAPB) in patients undergoing Modified Radical Mastectomy. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Adjuvants, Anesthesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to Dec 2023
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA II patients, BMI< 35Kg/m2
Who cannot join
- refusal of participation, ASA III or above, history of allergy to the study drugs, BMI> 35kg/m2, coagulation disorders, psychiatric illnesses that may interfere with pain evaluation, epileptic patients, patients with tachy or brady arrthymias, patients with increased intracranial tension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Ketamine Versus Neostigmine as Adjuvants to Bupivacaine During Ultrasound-guided Serratus Anterior Plane Block in Modified Radical Mastectomy
This study is designed to investigate the analgesic efficacy of ketamine compared to neostigmine as adjuvants to LA in ultrasound guided Serratus Anterior Plane Block (SAPB) in patients undergoing Modified Radical Mastectomy. We hypothesize that adding either neostigmine or ketamine to bupivacaine in ultrasound guided SAPB would increase the total analgesic duration and decrease the total 24 hr postoperative Nalbuphine consumption compared to SAPB with bupivacaine only. The first 24 hr of postoperative Nalbuphine consumption is set as the primary outcome. The time of the first request of analgesia, pain score, side effects of drugs and patient hemodynamics are set as the secondary outcomes.
- Conditions
- Post Operative Pain
- Being tested
- Adjuvants, Anesthesia
- Keywords
- mastectomy, postoperative pain, serratus anterior block, adjuvants
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvants, AnesthesiaDrug
testing the effect of adding ketamine versus neostigmine to the analgesic efficacy of serratus anterior plane block in modified radical mastectomy surgeries
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | consists of patients receiving Serratus anterior plane block using Bupivacaine + Ketamine. Receives: Drug: Adjuvants, Anesthesia |
| group 2 | Active comparator | consists of patients receiving Serratus anterior plane block using Bupivacaine + neostigmine. Receives: Drug: Adjuvants, Anesthesia |
| group 3 | Placebo comparator | consists of patients receiving Serratus anterior plane block using Bupivacaine + normal saline. Receives: Drug: Adjuvants, Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgsic consumption
total amount of consumed nalbuphine
Measured: first 24 hours postoperative
Secondary outcomes (2)
time to rescue analgesia
first time to request rescue analgesia
Measured: first 24 hours postoperative
pain scores
pain scores measured by numerical pain score chart
Measured: first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Jan 2023
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Hisham, Ain Shams University
- Investigators
- Mohammed S Abd El Aziz, M.D., Study director, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802979
- Sponsor's protocol ID
- FMASU MD 209/2022
- Status last verified
- Mar 2023
- First submitted
- 26 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelhamid BM, Samy S, Abdalla A, Saad A, Ollaek M, Ahmed A. Ketamine versus neostigmine as adjuvants to bupivacaine during ultrasound-guided serratus anterior plane block in modified radical mastectomy. A randomized controlled trial. Egyptian Journal of Anaesthesia. 2021; 37(1):356-363.
Elbahrawy K, El-Deeb A. The effects of adding neostigmine to supraclavicular brachial plexus block for postoperative analgesia in chronic renal failure patients: a prospective randomized double-blinded study. Research and Opinion in Anesthesia and Intensive Care. 2016; 3(1):36-41. Omar AM, Mansour MA, Abdelwahab HH, Aboushanab OH
Pandey 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 27746548Rashwan DAEK, Mohammed AR, Kasem Rashwan SA, Abd El Basset AS, Nafady HA. Efficacy of Serratus Anterior Plane Block Using Bupivacaine/ Magnesium Sulfate Versus Bupivacaine/ Nalbuphine for Mastectomy: A Randomized, Double-Blinded Comparative Study. Anesth Pain Med. 2020 Jun 22;10(3):e103141. doi: 10.5812/aapm.103141. eCollection 2020 Jun.
PubMed 32944562
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Ketamine Versus Neostigmine as Adjuvants to Bupivacaine During Ultrasound-guided Serratus Anterior Plane Block in Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT05802979
- Acronym / sponsor ID
- FMASU MD 209/2022
- Conditions
- Post Operative Pain
- Keywords
- mastectomy, postoperative pain, serratus anterior block, adjuvants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Apr 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 study is designed to investigate the analgesic efficacy of ketamine compared to neostigmine as adjuvants to LA in ultrasound guided Serratus Anterior Plane Block (SAPB) in patients undergoing Modified Radical Mastectomy. We hypothesize that adding either neostigmine or ketamine to bupivacaine in ultrasound guided SAPB would increase the total analgesic duration and decrease the total 24 hr postoperative Nalbuphine consumption compared to SAPB with bupivacaine only. The first 24 hr of postoperative Nalbuphine consumption is set as the primary outcome. The time of the first request of analgesia, pain score, side effects of drugs and patient hemodynamics are set as the secondary outcomes.
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 |
|---|---|---|
| group 1 | Active comparator | Drug: Adjuvants, Anesthesiaconsists of patients receiving Serratus anterior plane block using Bupivacaine + Ketamine. |
| group 2 | Active comparator | Drug: Adjuvants, Anesthesiaconsists of patients receiving Serratus anterior plane block using Bupivacaine + neostigmine. |
| group 3 | Placebo comparator | Drug: Adjuvants, Anesthesiaconsists of patients receiving Serratus anterior plane block using Bupivacaine + normal saline. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA II patients, BMI< 35Kg/m2
Key exclusion criteria (1 listed)
- refusal of participation, ASA III or above, history of allergy to the study drugs, BMI> 35kg/m2, coagulation disorders, psychiatric illnesses that may interfere with pain evaluation, epileptic patients, patients with tachy or brady arrthymias, patients with increased intracranial tension
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 |
|---|---|---|
| Adjuvants, Anesthesiatesting the effect of adding ketamine versus neostigmine to the analgesic efficacy of serratus anterior plane block in modified radical mastectomy surgeries | Drug | group 1, group 2, group 3 |
Primary outcome
analgsic consumption
Time frame: first 24 hours postoperative
total amount of consumed nalbuphine
2 secondary outcomes
time to rescue analgesia
Time frame: first 24 hours postoperative
pain scores
Time frame: first 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- BackgroundAbdelhamid BM, Samy S, Abdalla A, Saad A, Ollaek M, Ahmed A. Ketamine versus neostigmine as adjuvants to bupivacaine during ultrasound-guided serratus anterior plane block in modified radical mastectomy. A randomized controlled trial. Egyptian Journal of Anaesthesia. 2021; 37(1):356-363.
- BackgroundElbahrawy K, El-Deeb A. The effects of adding neostigmine to supraclavicular brachial plexus block for postoperative analgesia in chronic renal failure patients: a prospective randomized double-blinded study. Research and Opinion in Anesthesia and Intensive Care. 2016; 3(1):36-41. Omar AM, Mansour MA, Abdelwahab HH, Aboushanab OH
- 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 32944562Rashwan DAEK, Mohammed AR, Kasem Rashwan SA, Abd El Basset AS, Nafady HA. Efficacy of Serratus Anterior Plane Block Using Bupivacaine/ Magnesium Sulfate Versus Bupivacaine/ Nalbuphine for Mastectomy: A Randomized, Double-Blinded Comparative Study. Anesth Pain Med. 2020 Jun 22;10(3):e103141. doi: 10.5812/aapm.103141. eCollection 2020 Jun.
- Individual participant dataSharing planned: No
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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.
Mohammed S Abd El Aziz, M.D. study director
AinShams University
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 Adjuvants, Anesthesia in people with Post Operative Pain, run by Ain Shams 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 1 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: status not confirmed, as of the sponsor's last update on 7 Apr 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. 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 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?
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?
analgsic consumption (time frame: first 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 NCT05802979, which also lists 4 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 7 Apr 2023.