AzTrials
AzTrials

Cesarean Section; Complications, Wound, Infection (Following Delivery)Phase 2/3NCT03626753

Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section

A Phase 2/3 study testing Nefopam 20 MG/ML, "Nefopam (Acupan)" 20 MG/ML Injectable Solution and "Acetaminophen, (paracetamol)" 500Mg Tab in people with Cesarean Section; Complications, Wound, Infection (Following Delivery) and Postoperative Pain, run by Centre de Maternité de Monastir at 1 site in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Many drugs with various mechanisms of action are used for postcaesarean pain relief. Although the response to pain relief is sometimes believed to be individual, it is very important to establish the most effective with the least adverse effects type of oral analgesia for women after caesarean section. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Nefopam 20 MG/ML, "Nefopam (Acupan)" 20 MG/ML Injectable Solution and "Acetaminophen, (paracetamol)" 500Mg Tab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteTunisia
Study dates
1 Jan 2015to 30 Jun 2015
Phase
Phase 2/3
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pregnant in singleton pregnancy with gestational age > 34 weeks
  • American society of anesthesiologists (ASA) physical status I-II.

Who cannot join

  • history of gastrointestinal disorders predisposing to bleeding disorders such as ulcerative colitis,
  • Crohn's disease,
  • gastrointestinal cancers or diverticulitis,
  • an active peptic ulcer,
  • an inflammatory gastrointestinal disorder or a gastrointestinal haemorrhage,
  • parturients who present preeclampsia,
Show all 13Show fewer
  • premature delivery (<32 weeks),
  • constitutional or acquired coagulopathy,
  • An antecedent of hemorrhage of the delivery,
  • a hemorrhagic complication postoperatively,
  • Anemia (hemoglobin less than 8g / 100ml),
  • conversion of spinal anesthesia into general anesthesia,
  • women with severe medical conditions: renal failure (preoperative creatinine clearance <30ml / min), heart or liver failure.

Trial locations and contacts

1 site in 1 country.

Tunisia1 site

  • Centre de Maternité de Monastir

    Monastir, 5000

Other trials in Tunisia

About this study

Official title: Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section Oral vs Intravenous

Many drugs with various mechanisms of action are used for postcaesarean pain relief. Although the response to pain relief is sometimes believed to be individual, it is very important to establish the most effective with the least adverse effects type of oral analgesia for women after caesarean section. Optimal pain control post-caesarean section will benefit not only the mother and her baby, but also a healthcare system. Optimal pain control may shorten the time spent in hospital after caesarean section and, therefore, reduce healthcare costs.

Read the detailed description

Pain after cesarean section (CS), usually described as strong, is an obstacle to good mother-child interaction and post-operative rehabilitation. Its management is important for a quick recovery and allow the mother to take care and link with her newborn. Currently, intrathecal opioids are the most commonly used technique and provide the foundation for post-cesarean analgesia. This technique combined with multimodal analgesia reduces the doses of morphine consumed, including these side effects. Spinal anesthesia is the standard anesthetic technique for caesarean section; it offers several advantages including the possibility of prescribing oral analgesics. An ideal analgesic protocol is one that is simple to implement, cost-effective, and has minimal impact on the work staff. It would have a good safety profile, a low incidence of side effects and complications, and respond to wide inter-patient variability. It relieves the mother of high quality pain while having minimal interference with her, newborn care and anesthesia while allowing safe breastfeeding.

The aim of this work is to compare the quality of an multimodal oral analgesia with intravenous analgesia and to demonstrate non-inferiority of the oral route pain relieve in postoperative caesarean section period. The secondary objectives was to evaluate the maternal tolerance of the drugs (piroxicam, nefopam, paracetamol) used postoperatively of a caesarean section.

Being tested
Nefopam 20 MG/ML, "Nefopam (Acupan)" 20 MG/ML Injectable Solution, "Acetaminophen, (paracetamol)" 500Mg Tab, (Acetaminophen "paracetamol") IV Soln 10 MG/ML, (Piroxicam "piroxan") 20 MG Oral Tablet
Keywords
Pain, multimodal, analgesia, postoperative, cesarean section, obstetric, Agents, Physiological effects of drugs, opioid, Paracetamol, NSAIDs
Medical subject headings
Wounds and Injuries, Infections, Pain, Postoperative, Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nefopam 20 MG/MLDrug

    Also called 2 ampoule

    given by Oral route the dose of 20mg every 6 hours.

  • "Nefopam (Acupan)" 20 MG/ML Injectable SolutionDrug

    Also called 2 ampoule

    given by intravenous route at the dose of 20mg every 6 hours.

  • "Acetaminophen, (paracetamol)" 500Mg TabDrug

    Also called 2 tablets

    2 tablets of "Acetaminophen (paracetamol)" 500Mg Tab administrated orally every 6 hours.

  • (Acetaminophen "paracetamol") IV Soln 10 MG/MLDrug

    Also called 1 ampoule: 1g

    Acetaminophen IV Soln 10 MG/ML, 1g paracetamol administrated intravenously every 6 hours.

  • (Piroxicam "piroxan") 20 MG Oral TabletDrug

    Also called 2 tablets

    2 tablets of "piroxicam (piroxan)" administrated orally once per 24 hours.

  • (Piroxicam "piroxan") 20Mg/1mL InjectionDrug

    Also called 2 ampoules

    2 ampoules of (piroxicam "piroxan") administrated intravenously once per 24 hours.

Study groups in NCT03626753
Study groupRoleWhat they receive
Oral GroupActive comparatorreceived in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Receives: Drug: Nefopam 20 MG/ML; Drug: "Acetaminophen, (paracetamol)" 500Mg Tab; Drug: (Piroxicam "piroxan") 20 MG Oral Tablet
Intravenous groupActive comparatorreceived in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Receives: Drug: "Nefopam (Acupan)" 20 MG/ML Injectable Solution; Drug: (Acetaminophen "paracetamol") IV Soln 10 MG/ML; Drug: (Piroxicam "piroxan") 20Mg/1mL Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analogue Scale (VAS) pain

    from 0 - 10 (with 0 being no pain and 10 being the most severe pain imaginable) at rest and coughing or mobilization

    Measured: 24 hours postoperative

Secondary outcomes (3)

  1. morphine consumption

    morphine consumption

    Measured: 24 hours postoperative

  2. sides effects

    the occurrence of any undesirable effects related to the administration of any of the 3 drugs (nausea, vomiting, diarrhea, malaise, hypotension, sweating, convulsion, dryness of the mouth, tachycardia, palpitations, vertigo, allergic reactions)

    Measured: 24 hours postoperative

  3. postoperative complications

    The occurrence of a postoperative complication (postpartum haemorrhage, blood transfusion, hysterectomy, etc).

    Measured: 24 hours post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2018
  2. Study start1 Jan 2015
  3. Primary completion30 Jun 2015
  4. Study completion30 Jun 2015

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03626753
Sponsor's protocol ID
CMNMonastir
Status last verified
Aug 2018
First submitted
31 Jul 2018
Last updated
15 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mahajan L, Mittal V, Gupta R, Chhabra H, Vidhan J, Kaur A. Study to Compare the Effect of Oral, Rectal, and Intravenous Infusion of Paracetamol for Postoperative Analgesia in Women Undergoing Cesarean Section Under Spinal Anesthesia. Anesth Essays Res. 2017 Jul-Sep;11(3):594-598. doi: 10.4103/0259-1162.206872.

    PubMed 28928554

  • Mkontwana N, Novikova N. Oral analgesia for relieving post-caesarean pain. Cochrane Database Syst Rev. 2015 Mar 29;2015(3):CD010450. doi: 10.1002/14651858.CD010450.pub2.

    PubMed 25821010

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nefopam 20 MG/ML, "Nefopam (Acupan)" 20 MG/ML Injectable Solution and "Acetaminophen, (paracetamol)" 500Mg Tab in people with Cesarean Section; Complications, Wound, Infection (Following Delivery) and Postoperative Pain, run by Centre de Maternité de Monastir at 1 site in Tunisia.

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 13 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: finished, as of the sponsor's last update on 15 Aug 2018. 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 Tunisia. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Analogue Scale (VAS) pain (time frame: 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 NCT03626753, which also lists 2 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 15 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in