Clinical trial NCT03626753: Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section
Official title: Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section Oral vs Intravenous
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cesarean Section; Complications, Wound, Infection (Following Delivery)
Postoperative Pain
Spinal Anaesthesia During the Puerperium
Keywords: Pain
multimodal
analgesia
postoperative
cesarean section
obstetric
Agents
Physiological effects of drugs
opioid
Paracetamol
NSAIDs
Lead sponsor: Centre de Maternité de Monastir
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analogue Scale (VAS) pain
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: morphine consumption
timeFrame: 24 hours postoperative
measure: sides effects
timeFrame: 24 hours postoperative
measure: postoperative complications
timeFrame: 24 hours post operative
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Centre de Maternité de Monastir
Study officials:
References:
citation: 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.
citation: 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.