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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04259073
Other study ID # KMalek
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date October 10, 2018

Study information

Verified date February 2020
Source Hôpital Universitaire Fattouma Bourguiba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 138
Est. completion date October 10, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pregabalin 150mg
two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section
Placebos
two capsules filled with sugar ingested orally one hour before cesarean section
Pregabalin 300mg
two capsules of pregabalin 150 mg ingested orally one hour before cesarean section

Locations

Country Name City State
Tunisia Monastir maternity and neonatology center Monastir

Sponsors (1)

Lead Sponsor Collaborator
Hôpital Universitaire Fattouma Bourguiba

Country where clinical trial is conducted

Tunisia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to first analgesic request in minutes, the time between the end of the operation to the first demand of analgesics 24 hours
Secondary Visual analog scale (VAS) at rest and movement Checked at hours 2, 4, 6,12,18 and 24 post operatively 24 hours
Secondary Maternal satisfaction Measured by a Visual Analog Scale, ranging from 0 to 100; 0=not satisfied at all 24 hours
Secondary Maternal consumption of paracetamol postoperatively grams 24 hours
Secondary Apgar scores Ranging from 0 to 10; 7 to 10 correspond to an excellent condition 1 and 5 minutes after birth
Secondary Heart rate beats per minute Per operative period
Secondary Non-invasive blood pressure measured in millimeters of mercury Per operative period
Secondary Visual disturbances present or not 24 hours post operatively
Secondary Fluids administered to the mother per operatively in milliliters Per operative period
Secondary Dose of ephedrine administered to the mother per operatively in milligrams Per operative period
Secondary Ramsay score for sedation Ranging from 1 to 6 24 hours post operatively
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