Regional AnesthesiaNCT02711072
Continuous Infusion for Pain Relief
A study testing infiltration group in people with Regional Anesthesia and Caeserian Section, run by Tunisian Military Hospital.
Trial summary
SPINAL anesthesia is commonly used for cesarean section, and it has become a popular practice to add opioids to spinal solutions to enhance and prolong intraoperative and postoperative analgesia. high incidence of side effects was noted. is there any alternative? Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Regional Anesthesia, Caeserian Section, Local Anesthetic
- What is being tested?
- infiltration group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2016
- 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
- ASA physical status I-II
- 18-45 years of age, inclusive
- elective caeserean section under spinal anesthesia
Who cannot join
- - contraindications to spinal anesthesia (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
- existing neurological deficit
- inability to understand the informed consent and demands of the study
About this study
Official title: Comparaison of Continuous Infusion of Local Anesthetic and Intrathecal Morphine for Pain Management in Elective Caeserean Section
SPINAL anesthesia is commonly used for cesarean section, and it has become a popular practice to add opioids to spinal solutions to enhance and prolong intraoperative and postoperative analgesia. high incidence of side effects was noted. is there any alternative?
- Conditions
- Regional Anesthesia, Caeserian Section, Local Anesthetic
- Being tested
- control group, infiltration group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupDrug
spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 100 µ of intrathecal Morphine+ infiltration catheter with saline 5 ml/h
infiltration groupDrug
spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 1ml of saline + infiltration catheter with 5 ml/h of Bupivacaïne 0,125%.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Not described Receives: Drug: control group; Drug: infiltration group |
| infiltration group | Active comparator | Not described Receives: Drug: control group; Drug: infiltration group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogic Scale
quality of postoperative analgesia
Measured: until 48 hours postoperative
Secondary outcomes (2)
occurrence of complications
Measured: 48 hours post operative
total dose of morphine consumption in mg
Measured: during 48 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies 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
- Treatment
- 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
- Tunisian Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr trabelsi walid, Tunisian Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711072
- Sponsor's protocol ID
- tunisian hh2
- Status last verified
- Mar 2016
- First submitted
- 14 Mar 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparaison of Continuous Infusion of Local Anesthetic and Intrathecal Morphine for Pain Management in Elective Caeserean Section
- ClinicalTrials.gov ID
- NCT02711072
- Acronym / sponsor ID
- tunisian hh2
- Conditions
- Regional Anesthesia, Caeserian Section, Local Anesthetic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tunisian Military HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 17 Mar 2016 (estimated)
- 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.
SPINAL anesthesia is commonly used for cesarean section, and it has become a popular practice to add opioids to spinal solutions to enhance and prolong intraoperative and postoperative analgesia. high incidence of side effects was noted. is there any alternative?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: control group, Drug: infiltration group |
| infiltration group | Active comparator | Drug: control group, Drug: infiltration group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA physical status I-II
- 18-45 years of age, inclusive
- elective caeserean section under spinal anesthesia
Key exclusion criteria (3 listed)
- - contraindications to spinal anesthesia (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
- existing neurological deficit
- inability to understand the informed consent and demands of the study
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 |
|---|---|---|
| control groupspinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 100 µ of intrathecal Morphine+ infiltration catheter with saline 5 ml/h | Drug | control group, infiltration group |
| infiltration groupspinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 1ml of saline + infiltration catheter with 5 ml/h of Bupivacaïne 0,125%. | Drug | control group, infiltration group |
Primary outcome
Visual Analogic Scale
Time frame: until 48 hours postoperative
quality of postoperative analgesia
2 secondary outcomes
occurrence of complications
Time frame: 48 hours post operative
total dose of morphine consumption in mg
Time frame: during 48 hours post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing infiltration group in people with Regional Anesthesia and Caeserian Section, run by Tunisian Military Hospital.
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 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 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Visual Analogic Scale (time frame: until 48 hours postoperative). 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 17 Mar 2016.