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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626753
• Other study ID #: CMNMonastir
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 1, 2015
• Est. completion date: June 30, 2015

Study information

• Verified date: August 2018
• Source: Centre de Maternité de Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Nefopam 20 MG/ML
given by Oral route the dose of 20mg every 6 hours.
• "Nefopam (Acupan)" 20 MG/ML Injectable Solution
given by intravenous route at the dose of 20mg every 6 hours.
• "Acetaminophen, (paracetamol)" 500Mg Tab
2 tablets of "Acetaminophen (paracetamol)" 500Mg Tab administrated orally every 6 hours.
• (Acetaminophen "paracetamol") IV Soln 10 MG/ML
Acetaminophen IV Soln 10 MG/ML, 1g paracetamol administrated intravenously every 6 hours.
• (Piroxicam "piroxan") 20 MG Oral Tablet
2 tablets of "piroxicam (piroxan)" administrated orally once per 24 hours.
• (Piroxicam "piroxan") 20Mg/1mL Injection
2 ampoules of (piroxicam "piroxan") administrated intravenously once per 24 hours.

Locations

Country	Name	City	State
Tunisia	Centre de Maternité de Monastir	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Maternité de Monastir

Country where clinical trial is conducted

Tunisia, 

References & Publications (2)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours postoperative
Secondary	morphine consumption	morphine consumption	24 hours postoperative
Secondary	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)	24 hours postoperative
Secondary	postoperative complications	The occurrence of a postoperative complication (postpartum haemorrhage, blood transfusion, hysterectomy, etc).	24 hours post operative