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

NCT ID: NCT03626753

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2015-06-30

Brief 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. 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.

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.

Conditions

Cesarean Section; Complications, Wound, Infection (Following Delivery); Postoperative Pain; Spinal Anaesthesia During the Puerperium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oral Group

received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)

Group Type: ACTIVE_COMPARATOR

Nefopam 20 MG/ML

Intervention Type: DRUG

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

"Acetaminophen, (paracetamol)" 500Mg Tab

Intervention Type: DRUG

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

(Piroxicam "piroxan") 20 MG Oral Tablet

Intervention Type: DRUG

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

Intravenous group

received in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)

Group Type: ACTIVE_COMPARATOR

"Nefopam (Acupan)" 20 MG/ML Injectable Solution

Intervention Type: DRUG

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

(Acetaminophen "paracetamol") IV Soln 10 MG/ML

Intervention Type: DRUG

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

(Piroxicam "piroxan") 20Mg/1mL Injection

Intervention Type: DRUG

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

Interventions

Nefopam 20 MG/ML

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

Intervention Type: DRUG

"Nefopam (Acupan)" 20 MG/ML Injectable Solution

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

Intervention Type: DRUG

"Acetaminophen, (paracetamol)" 500Mg Tab

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

Intervention Type: DRUG

(Acetaminophen "paracetamol") IV Soln 10 MG/ML

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

Intervention Type: DRUG

(Piroxicam "piroxan") 20 MG Oral Tablet

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

Intervention Type: DRUG

(Piroxicam "piroxan") 20Mg/1mL Injection

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

Intervention Type: DRUG

Other Intervention Names

2 ampoule; 2 ampoule; 2 tablets; 1 ampoule: 1g; 2 tablets; 2 ampoules

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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,
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre de Maternité de Monastir

OTHER

Sponsor Role: lead

Responsible Party

Fethi Jebali

Medical doctor, clinical professor of Anesthesiology and intensive care medecine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre de Maternité de Monastir

Monastir, , Tunisia

Countries

Tunisia

References

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.

Reference Type: BACKGROUND

PMID: 28928554 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25821010 (View on PubMed)

Other Identifiers

CMNMonastir

Identifier Type: -

Identifier Source: org_study_id