Clinical trial NCT04259073: Does Pregabalin Improve Post-operative Pain After C-section Delivery
Official title: Does Pregabalin Improve Post-operative Pain After C-section Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: postoperative pain
pregabalin
cesarean section
Lead sponsor: Hôpital Universitaire Fattouma Bourguiba
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Pregabalin due to its antihyperalgesic effect, has proven its efficacy on neuropathic pain, essentially in nociceptive surgeries. Few studies have attempted to identify the utility of pregabalin as a premedication before cesarean delivery.

The investigators aimed to determine whether or not pregabalin as premedication improves analgesia post cesarean delivery.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to first analgesic request
timeFrame: 24 hours
Secondary outcomes:
measure: Visual analog scale (VAS) at rest and movement
timeFrame: 24 hours
measure: Maternal satisfaction
timeFrame: 24 hours
measure: Maternal consumption of paracetamol postoperatively
timeFrame: 24 hours
measure: Apgar scores
timeFrame: 1 and 5 minutes after birth
measure: Heart rate
timeFrame: Per operative period
measure: Non-invasive blood pressure
timeFrame: Per operative period
measure: Visual disturbances
timeFrame: 24 hours post operatively
measure: Fluids administered to the mother per operatively
timeFrame: Per operative period
measure: Dose of ephedrine administered to the mother per operatively
timeFrame: Per operative period
measure: Ramsay score for sedation
timeFrame: 24 hours post operatively
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Monastir maternity and neonatology center
Study officials:
affiliation: Fattouma Bourguiba Hospital ICU
name: Malek Khemili, Resident
role: PRINCIPAL_INVESTIGATOR
References:
citation: El Kenany S, El Tahan MR. Effect of preoperative pregabalin on post-caesarean delivery analgesia: a dose-response study. Int J Obstet Anesth. 2016 May;26:24-31. doi: 10.1016/j.ijoa.2015.11.001. Epub 2015 Nov 12.
citation: Felder L, Saccone G, Scuotto S, Monks DT, Carvalho JCA, Zullo F, Berghella V. Perioperative gabapentin and post cesarean pain control: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2019 Feb;233:98-106. doi: 10.1016/j.ejogrb.2018.11.026. Epub 2018 Dec 12.