AnalgesiaNCT04446715
Comparison of Meperidine and Sufentanil Added to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Cesarean Section
A study testing sufentanil, meperidine and Bupivacaine in people with Analgesia, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Subarachnoid block is a widely used anesthetic technique for cesarean section. To improve the quality of analgesia and prolong its duration, the addition of intrathecal opioids to local anesthetics has been encouraged. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- sufentanil, meperidine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Oct 2020to Aug 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women with American Society of Anesthesiologist (ASA) 2-3
- scheduled for elective cesarean section.
Who cannot join
- refuse to participate in the study,
- requiring emergency obstetric care,
- ASA IV or V,
- having systemic diseases,
- a known fetal anomaly,
- placenta previa,
Show all 11Show fewer
- abruption placenta
- with a history of hypersensitivity or allergy to any of the study drugs,
- operation time longer than 1.5 hour,
- blood loss more than 1500 millilitres,
- those with any contraindication to the technique proposed,
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Makassed General Hospital
Beirut
Saleh Kanawati, MD, +9611636000 ext. 6405, s.kanawati@hotmail.com
About this study
Official title: Comparison of Clinical Effects of Meperidine and Sufentanil Added to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Patients Undergoing Cesarean Section
Subarachnoid block is a widely used anesthetic technique for cesarean section. To improve the quality of analgesia and prolong its duration, the addition of intrathecal opioids to local anesthetics has been encouraged.
In a double blind randomized controlled trial, 60 parturient women ASA 2-3 scheduled for elective cesarean delivery under spinal anesthesia will be randomly divided into 2 groups: Group 1 will receive sufentanil 5 μg and Group 2 will receive meperidine 12.5 mg. In every group, 0.5% heavy bupivacaine 10 will be added.
Read the detailed description
A questionnaire will be used to collect data. Patients' demographic and operative characteristics will be recorded. These include block level, heart rate, mean arterial pressure, nausea, vomiting, shivering and use of vasopressors. Post-operative data include pain, analgesic consumption, nausea and vomiting, as well as patients and surgeons satisfaction.
- Conditions
- Analgesia
- Being tested
- sufentanil, meperidine, Bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sufentanilDrug
Patients will receive sufentanil in spinal anesthesia
meperidineDrug
Patients will receive meperidine in spinal anesthesia
BupivacaineDrug
Patients will receive 0.5% heavy bupivacaine in spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil Group | Experimental | Patients will receive sufentanil 5 μg in addition to 0.5% heavy bupivacaine spinal anesthesia Receives: Drug: sufentanil; Drug: Bupivacaine |
| Meperidine Group | Experimental | Patients will receive meperidine 12.5 mg in addition to 0.5% heavy bupivacaine spinal anesthesia Receives: Drug: meperidine; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
First analgesic request time
The duration of effective analgesia is defined as the time from intrathecal injection to first patient analgesic demand
Measured: 24 hours post operatively
Secondary outcomes (1)
Analgesic requirements
A questionnaire will be used to record the analgesics consumed by the patients
Measured: 24 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Oct 2020
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
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 AnalgesiaStudies 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 N/A
- Primary purpose
- Other
- 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
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saleh Kanawati, Makassed General Hospital
- Investigators
- Saleh Kanawati, MD, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446715
- Sponsor's protocol ID
- 17062020
- Status last verified
- Jul 2021
- First submitted
- 19 Jun 2020
- Last updated
- 30 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kanawati S, Barada MA, Naja Z, Rajab O, Sinno L, El Hasan J. Comparison of clinical effects of meperidine and sufentanil added to 0.5% hyperbaric bupivacaine for spinal anesthesia in patients undergoing cesarean delivery: a randomized controlled trial. J Anesth. 2022 Apr;36(2):201-209. doi: 10.1007/s00540-021-03031-6. Epub 2022 Jan 27.
PubMed 35083557
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Effects of Meperidine and Sufentanil Added to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT04446715
- Acronym / sponsor ID
- 17062020
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 25 Jun 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.
Subarachnoid block is a widely used anesthetic technique for cesarean section. To improve the quality of analgesia and prolong its duration, the addition of intrathecal opioids to local anesthetics has been encouraged.
In a double blind randomized controlled trial, 60 parturient women ASA 2-3 scheduled for elective cesarean delivery under spinal anesthesia will be randomly divided into 2 groups: Group 1 will receive sufentanil 5 μg and Group 2 will receive meperidine 12.5 mg. In every group, 0.5% heavy bupivacaine 10 will be added.
Detailed description
A questionnaire will be used to collect data. Patients' demographic and operative characteristics will be recorded. These include block level, heart rate, mean arterial pressure, nausea, vomiting, shivering and use of vasopressors. Post-operative data include pain, analgesic consumption, nausea and vomiting, as well as patients and surgeons satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sufentanil Group | Experimental | Drug: sufentanil, Drug: BupivacainePatients will receive sufentanil 5 μg in addition to 0.5% heavy bupivacaine spinal anesthesia |
| Meperidine Group | Experimental | Drug: meperidine, Drug: BupivacainePatients will receive meperidine 12.5 mg in addition to 0.5% heavy bupivacaine spinal anesthesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant women with American Society of Anesthesiologist (ASA) 2-3
- scheduled for elective cesarean section.
Key exclusion criteria (11 listed)
- refuse to participate in the study,
- requiring emergency obstetric care,
- ASA IV or V,
- having systemic diseases,
- a known fetal anomaly,
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 |
|---|---|---|
| sufentanilPatients will receive sufentanil in spinal anesthesia | Drug | Sufentanil Group |
| meperidinePatients will receive meperidine in spinal anesthesia | Drug | Meperidine Group |
| BupivacainePatients will receive 0.5% heavy bupivacaine in spinal anesthesia | Drug | Meperidine Group, Sufentanil Group |
Primary outcome
First analgesic request time
Time frame: 24 hours post operatively
The duration of effective analgesia is defined as the time from intrathecal injection to first patient analgesic demand
1 secondary outcome
Analgesic requirements
Time frame: 24 hours post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Derived from this study: PubMed 35083557Kanawati S, Barada MA, Naja Z, Rajab O, Sinno L, El Hasan J. Comparison of clinical effects of meperidine and sufentanil added to 0.5% hyperbaric bupivacaine for spinal anesthesia in patients undergoing cesarean delivery: a randomized controlled trial. J Anesth. 2022 Apr;36(2):201-209. doi: 10.1007/s00540-021-03031-6. Epub 2022 Jan 27.
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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.
Saleh Kanawati, MD principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sufentanil, meperidine and Bupivacaine in people with Analgesia, run by Makassed General Hospital at 1 site in Lebanon.
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 11 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 30 Jul 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 Lebanon. 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.
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 Saleh Kanawati, MD (+9611636000 ext. 6405, s.kanawati@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First analgesic request time (time frame: 24 hours post operatively). 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 NCT04446715, 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 30 Jul 2021.