Postoperative Pain Clinical Trial
Official title:
Does Pregabalin Improve Post-operative Pain After C-section Delivery
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 |
Verified date | February 2020 |
Source | Hôpital Universitaire Fattouma Bourguiba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Tunisia | Monastir maternity and neonatology center | Monastir |
Lead Sponsor | Collaborator |
---|---|
Hôpital Universitaire Fattouma Bourguiba |
Tunisia,
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
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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