Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C | Placebo Comparator | two capsules filled with sugar |
|
| Group P150 | Active Comparator | two capsules; one of them containing sugar (like the placebo one), the other is the active drug (pregabalin 150 mg) |
|
| Group P300 | Active Comparator | two capsules of pregabalin (150 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 150mg | Drug | two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first analgesic request | in minutes, the time between the end of the operation to the first demand of analgesics | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale (VAS) at rest and movement | Checked at hours 2, 4, 6,12,18 and 24 post operatively | 24 hours |
| Maternal satisfaction | Measured by a Visual Analog Scale, ranging from 0 to 100; 0=not satisfied at all |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Malek Khemili, Resident | Fattouma Bourguiba Hospital ICU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monastir maternity and neonatology center | Monastir | 5000 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26718698 | Background | 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. | |
| 30583095 | Background | 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. |
Not provided
Not provided
principal outcomes measured in the study
March 2020 for one year
after request by mailing
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D051416 | Focal Adhesion Protein-Tyrosine Kinases |
| D050881 | E1A-Associated p300 Protein |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebos | Drug | two capsules filled with sugar ingested orally one hour before cesarean section |
|
|
| Pregabalin 300mg | Drug | two capsules of pregabalin 150 mg ingested orally one hour before cesarean section |
|
|
| 24 hours |
| Maternal consumption of paracetamol postoperatively | grams | 24 hours |
| Apgar scores | Ranging from 0 to 10; 7 to 10 correspond to an excellent condition | 1 and 5 minutes after birth |
| Heart rate | beats per minute | Per operative period |
| Non-invasive blood pressure | measured in millimeters of mercury | Per operative period |
| Visual disturbances | present or not | 24 hours post operatively |
| Fluids administered to the mother per operatively | in milliliters | Per operative period |
| Dose of ephedrine administered to the mother per operatively | in milligrams | Per operative period |
| Ramsay score for sedation | Ranging from 1 to 6 | 24 hours post operatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011505 | Protein-Tyrosine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D050880 | p300-CBP Transcription Factors |
| D051548 | Histone Acetyltransferases |
| D000070837 | Lysine Acetyltransferases |
| D000123 | Acetyltransferases |
| D000217 | Acyltransferases |
| D014157 | Transcription Factors |