Does Pregabalin Improve Post-operative Pain After C-section Delivery
Avainsanat
Abstrakti
Kuvaus
The investigators conducted a controlled, randomised, prospective and double-blind trial. One hundred thirty eight participants were included, with American Society of Anesthesiologists physical status classification of I to II, with pregnancies of at least 36 weeks of gestation who were scheduled for elective caesarean delivery under spinal anaesthesia. One hour before induction of anaesthesia participants received a capsule containing sugar placebo (placebo group), pregabalin 150 mg or pregabalin 300 mg. Data related to surgical history, pre-existing medical problems, indications for cesarean and peroperative hemodynamic changes were analyzed. The primary outcome was first analgesic request. Secondary outcomes included maternal pain scores at rest and during movement, rescue analgesics consumption, sedation, nausea, vomiting, pruritus and Apgar scores. All maternal secondary outcome variables were recorded 0, 2, 4, 6, 12, 18, and 24 h after delivery. Common side effects linked to pregabalin such as somnolence, blurred or abnormal vision, or fetal distress were collected.
Päivämäärät
| Viimeksi vahvistettu: | 01/31/2020 |
| Ensimmäinen lähetys: | 02/02/2020 |
| Arvioitu ilmoittautuminen lähetetty: | 02/03/2020 |
| Ensimmäinen lähetetty: | 02/05/2020 |
| Viimeisin päivitys lähetetty: | 02/03/2020 |
| Viimeisin päivitys lähetetty: | 02/05/2020 |
| Todellinen opintojen alkamispäivä: | 02/28/2018 |
| Arvioitu ensisijainen valmistumispäivä: | 06/29/2018 |
| Arvioitu tutkimuksen valmistumispäivä: | 10/09/2018 |
Ehto tai tauti
Interventio / hoito
Drug: Group P150
Drug: Group C
Drug: Group P300
Vaihe
Varren ryhmät
| Varsi | Interventio / hoito |
|---|---|
| Placebo Comparator: Group C two capsules filled with sugar | Drug: Group C two capsules filled with sugar ingested orally one hour before cesarean section |
| Active Comparator: Group P150 two capsules; one of them containing sugar (like the placebo one), the other is the active drug (pregabalin 150 mg) | Drug: Group P150 two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section |
| Active Comparator: Group P300 two capsules of pregabalin (150 mg) | Drug: Group P300 two capsules of pregabalin 150 mg ingested orally one hour before cesarean section |
Kelpoisuusehdot
| Tutkimukseen soveltuvat iät | 18 Years Vastaanottaja 18 Years |
| Sukupuolet, jotka ovat kelpoisia tutkimukseen | Female |
| Hyväksyy terveelliset vapaaehtoiset | Joo |
| Kriteeri | Inclusion Criteria: - American Society of Anesthesiologists class I or II - single pregnancies at term - under spinal anesthesia Exclusion Criteria: - conversion to general anesthesia - post partum hemorrhage requiring specific resuscitation - local anesthetic toxicity - violation of the protocol |
Tulokset
Ensisijaiset tulosmittaukset
1. Time to first analgesic request [24 hours]
Toissijaiset tulosmittaukset
1. Visual analog scale (VAS) at rest and movement [24 hours]
2. Maternal satisfaction [24 hours]
3. Maternal consumption of paracetamol postoperatively [24 hours]
4. Apgar scores [1 and 5 minutes after birth]
5. Heart rate [Per operative period]
6. Non-invasive blood pressure [Per operative period]
7. Visual disturbances [24 hours post operatively]
8. Fluids administered to the mother per operatively [Per operative period]
9. Dose of ephedrine administered to the mother per operatively [Per operative period]
10. Ramsay score for sedation [24 hours post operatively]
