Pain, PostoperativeNCT04618146
Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine.
A study testing Morphine Sulfate and Bupivacaine Hydrochloride in people with Pain, Postoperative and Pruritus, run by Minia University at 1 site in Egypt.
Trial summary
This study is designed to see the effect of low dose intrathecal morphine on promting enhanced recovery after cesarean delivery with early ambulation and reduction of hospital stay. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Pain, Postoperative, Pruritus, Nausea, Postoperative
- What is being tested?
- Morphine Sulfate and Bupivacaine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2020to Mar 2021
- 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 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Females scheduled for cesarean section
- Age: 16-45 yrs.
- Gestation age >38 weeks.
- ASA I,II
Who cannot join
- Refusal to participate.
- Significant cardiac, hepatic or renal dysfunction.
- History of chronic itching problem, or hyperemesis during pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Minia university
Minya
Sohair A Megalla, MD, 01200036447, Sohair.Adeeb@minia.edu.eg
About this study
Official title: Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine. A Prospective Randomized Controlled Study.
This study is designed to see the effect of low dose intrathecal morphine on promting enhanced recovery after cesarean delivery with early ambulation and reduction of hospital stay.
Read the detailed description
Parturients showing for elective cesarean section will be randomized into 3 groups by a computer generated randomization list. Each randomization slip will be put in a sealed envelope until patient enrollment. Patients will be divided into Group C: control group, given intrathecal bupivacaine 12.5 mg. Group M25: intrathecal bupivacaine 12.5mg + morphine 25 microgram. Group M50: intrathecal bupivacaine 12.5mg + morphine 50 microgram.
- Being tested
- Morphine Sulfate, Bupivacaine Hydrochloride
- Keywords
- pain, morphine, cesarean section, enhanced recovery
- Medical subject headings
- Pain, Postoperative, Pruritus, Postoperative Nausea and Vomiting, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine SulfateDrug
Also called morphine
intrathecal low dose morphine for early return to normal activity without opioid related complications.
Bupivacaine HydrochlorideDrug
Also called marcaine
intrathecal bupivacaine 0.5%
| Study group | Role | What they receive |
|---|---|---|
| Group C | Placebo comparator | given intrathecal bupivacaine 12.5 mg. Receives: Drug: Bupivacaine Hydrochloride |
| Group M25 | Active comparator | given intrathecal bupivacaine 12.5mg + morphine 25 microgram. Receives: Drug: Morphine Sulfate; Drug: Bupivacaine Hydrochloride |
| Group M50 | Active comparator | given intrathecal bupivacaine 12.5mg + morphine 50 microgram. Receives: Drug: Morphine Sulfate; Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain postoperative
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Measured: 2 hours postoperatively
Pain postoperative
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Measured: 4 hours postoperatively
Pain postoperative
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Measured: 24 hours postoperatively
Secondary outcomes (7)
vomiting
four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting).
Measured: 2 hours postoperative
vomiting
four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting).
Measured: 4 hours postoperative
vomiting
four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting).
Measured: 24 hours postoperative
itching
four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body).
Measured: 2 hours postoperative
itching
four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body).
Measured: 4 hours postoperative
itching
four-point rating score (1: no itching, 2: mild,face, no traetment needed 3: severe itching, allover the body).
Measured: 24 hours postoperative
respiratory depression
respiratory rate less than 8 breaths \ minute
Measured: 4 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start10 Nov 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Minia 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohair Adeeb, Minia University
- Investigators
- Sohair A Megalla, MD, Principal investigator, Anesthesia and ICU department, Faculty of Medicine, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618146
- Sponsor's protocol ID
- 680-9\2020
- Status last verified
- Feb 2021
- First submitted
- 1 Nov 2020
- Last updated
- 1 Mar 2021
- 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 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Cesarean Section With Low Dose Intrathecal Morphine. A Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04618146
- Acronym / sponsor ID
- 680-9\2020
- Keywords
- pain, morphine, cesarean section, enhanced recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 5 Nov 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.
This study is designed to see the effect of low dose intrathecal morphine on promting enhanced recovery after cesarean delivery with early ambulation and reduction of hospital stay.
Detailed description
Parturients showing for elective cesarean section will be randomized into 3 groups by a computer generated randomization list. Each randomization slip will be put in a sealed envelope until patient enrollment. Patients will be divided into Group C: control group, given intrathecal bupivacaine 12.5 mg. Group M25: intrathecal bupivacaine 12.5mg + morphine 25 microgram. Group M50: intrathecal bupivacaine 12.5mg + morphine 50 microgram.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Placebo comparator | Drug: Bupivacaine Hydrochloridegiven intrathecal bupivacaine 12.5 mg. |
| Group M25 | Active comparator | Drug: Morphine Sulfate, Drug: Bupivacaine Hydrochloridegiven intrathecal bupivacaine 12.5mg + morphine 25 microgram. |
| Group M50 | Active comparator | Drug: Morphine Sulfate, Drug: Bupivacaine Hydrochloridegiven intrathecal bupivacaine 12.5mg + morphine 50 microgram. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Females scheduled for cesarean section
- Age: 16-45 yrs.
- Gestation age >38 weeks.
- ASA I,II
Key exclusion criteria (3 listed)
- Refusal to participate.
- Significant cardiac, hepatic or renal dysfunction.
- History of chronic itching problem, or hyperemesis during pregnancy
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 |
|---|---|---|
| Morphine SulfateAlso: morphineintrathecal low dose morphine for early return to normal activity without opioid related complications. | Drug | Group M25, Group M50 |
| Bupivacaine HydrochlorideAlso: marcaineintrathecal bupivacaine 0.5% | Drug | Group C, Group M25, Group M50 |
Primary outcome
Pain postoperative
Time frame: 2 hours postoperatively
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Pain postoperative
Time frame: 4 hours postoperatively
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Pain postoperative
Time frame: 24 hours postoperatively
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
7 secondary outcomes
vomiting
Time frame: 2 hours postoperative
vomiting
Time frame: 4 hours postoperative
vomiting
Time frame: 24 hours postoperative
itching
Time frame: 2 hours postoperative
itching
Time frame: 4 hours postoperative
itching
Time frame: 24 hours postoperative
respiratory depression
Time frame: 4 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
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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.
Sohair A Megalla, MD principal investigator
Anesthesia and ICU department, Faculty of Medicine, Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine Sulfate and Bupivacaine Hydrochloride in people with Pain, Postoperative and Pruritus, run by Minia 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 4 inclusion and 3 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 1 Mar 2021. 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.
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 Sohair A Megalla, MD (+20 120 003 6447, Sohair.Adeeb@minia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain postoperative (time frame: 2 hours postoperatively). The study lists 3 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 1 Mar 2021.