Postoperative PainNCT04259073
Does Pregabalin Improve Post-operative Pain After C-section Delivery
A study testing Pregabalin 150mg and Pregabalin 300mg in people with Postoperative Pain, run by Hôpital Universitaire Fattouma Bourguiba at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pregabalin 150mg and Pregabalin 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2018to 10 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists class I or II
- single pregnancies at term
- under spinal anesthesia
Who cannot join
- conversion to general anesthesia
- post partum hemorrhage requiring specific resuscitation
- local anesthetic toxicity
- violation of the protocol
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Pregabalin 150mg, Placebos, Pregabalin 300mg
- Keywords
- postoperative pain, pregabalin, cesarean section
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mgDrug
Also called P150
two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section
PlacebosDrug
Also called C
two capsules filled with sugar ingested orally one hour before cesarean section
Pregabalin 300mgDrug
Also called P300
two capsules of pregabalin 150 mg ingested orally one hour before cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Group C | Placebo comparator | two capsules filled with sugar Receives: Drug: Placebos |
| Group P150 | Active comparator | two capsules; one of them containing sugar (like the placebo one), the other is the active drug (pregabalin 150 mg) Receives: Drug: Pregabalin 150mg |
| Group P300 | Active comparator | two capsules of pregabalin (150 mg) Receives: Drug: Pregabalin 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesic request
in minutes, the time between the end of the operation to the first demand of analgesics
Measured: 24 hours
Secondary outcomes (10)
Visual analog scale (VAS) at rest and movement
Checked at hours 2, 4, 6,12,18 and 24 post operatively
Measured: 24 hours
Maternal satisfaction
Measured by a Visual Analog Scale, ranging from 0 to 100; 0=not satisfied at all
Measured: 24 hours
Maternal consumption of paracetamol postoperatively
grams
Measured: 24 hours
Apgar scores
Ranging from 0 to 10; 7 to 10 correspond to an excellent condition
Measured: 1 and 5 minutes after birth
Heart rate
beats per minute
Measured: Per operative period
Non-invasive blood pressure
measured in millimeters of mercury
Measured: Per operative period
Visual disturbances
present or not
Measured: 24 hours post operatively
Fluids administered to the mother per operatively
in milliliters
Measured: Per operative period
Dose of ephedrine administered to the mother per operatively
in milligrams
Measured: Per operative period
Ramsay score for sedation
Ranging from 1 to 6
Measured: 24 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Mar 2018
- Primary completion30 Jun 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Fattouma Bourguiba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khemili Malek, Hôpital Universitaire Fattouma Bourguiba
- Investigators
- Malek Khemili, Resident, Principal investigator, Fattouma Bourguiba Hospital ICU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259073
- Sponsor's protocol ID
- KMalek
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: principal outcomes measured in the study
Publications
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.
PubMed 26718698Felder 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.
PubMed 30583095
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pregabalin Improve Post-operative Pain After C-section Delivery
- ClinicalTrials.gov ID
- NCT04259073
- Acronym / sponsor ID
- KMalek
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, pregabalin, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Hôpital Universitaire Fattouma BourguibaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Placebo comparator | Drug: Placebostwo capsules filled with sugar |
| Group P150 | Active comparator | Drug: Pregabalin 150mgtwo capsules; one of them containing sugar (like the placebo one), the other is the active drug (pregabalin 150 mg) |
| Group P300 | Active comparator | Drug: Pregabalin 300mgtwo capsules of pregabalin (150 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists class I or II
- single pregnancies at term
- under spinal anesthesia
Key exclusion criteria (4 listed)
- conversion to general anesthesia
- post partum hemorrhage requiring specific resuscitation
- local anesthetic toxicity
- violation of the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin 150mgAlso: P150two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section | Drug | Group P150 |
| PlacebosAlso: Ctwo capsules filled with sugar ingested orally one hour before cesarean section | Drug | Group C |
| Pregabalin 300mgAlso: P300two capsules of pregabalin 150 mg ingested orally one hour before cesarean section | Drug | Group P300 |
Primary outcome
Time to first analgesic request
Time frame: 24 hours
in minutes, the time between the end of the operation to the first demand of analgesics
10 secondary outcomes
Visual analog scale (VAS) at rest and movement
Time frame: 24 hours
Maternal satisfaction
Time frame: 24 hours
Maternal consumption of paracetamol postoperatively
Time frame: 24 hours
Apgar scores
Time frame: 1 and 5 minutes after birth
Heart rate
Time frame: Per operative period
Non-invasive blood pressure
Time frame: Per operative period
Visual disturbances
Time frame: 24 hours post operatively
Fluids administered to the mother per operatively
Time frame: Per operative period
Dose of ephedrine administered to the mother per operatively
Time frame: Per operative period
Ramsay score for sedation
Time frame: 24 hours post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Background: PubMed 26718698El 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.
- Background: PubMed 30583095Felder 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.
- Individual participant dataSharing planned: Yes. principal outcomes measured in the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malek Khemili, Resident principal investigator
Fattouma Bourguiba Hospital ICU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin 150mg and Pregabalin 300mg in people with Postoperative Pain, run by Hôpital Universitaire Fattouma Bourguiba at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first analgesic request (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04259073, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.