Does Pregabalin Improve Post-operative Pain After C-section Delivery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Placebos; Drug: Pregabalin 150mg; Drug: Pregabalin 300mg

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.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Monastir maternity and neonatology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group C; two capsules filled with sugar	Drug: Placebos; two capsules filled with sugar ingested orally one hour before cesarean section; Other Names: C
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: Pregabalin 150mg; two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section; Other Names: P150
Active Comparator: Group P300; two capsules of pregabalin (150 mg)	Drug: Pregabalin 300mg; two capsules of pregabalin 150 mg ingested orally one hour before cesarean section; Other Names: P300

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hôpital Universitaire Fattouma Bourguiba
• Investigators: Principal Investigator: Malek Khemili, Resident, Fattouma Bourguiba Hospital ICU

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): October 10, 2018

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: cesarean section; pregabalin; postoperative pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: KMalek

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: principal outcomes measured in the study
• IPD Sharing Time Frame: March 2020 for one year
• IPD Sharing Access Criteria: after request by mailing
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No