PainNCT01848119
Does a Perioperative Course of Gabapentin Improve Analgesia After Cesarean Delivery?
A study testing Gabapentin and lactose in people with Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Gabapentin has been very effective at treating pain after knee and hip operations, hysterectomies, and many other types of operations. A previous study at the investigators' hospital found that a single pre-operative dose of 600mg gabapentin produced a significant reduction in pain after cesarean section. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Gabapentin and lactose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Feb 2014
- 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 16 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All women aged 16 years and over with term singleton pregnancies undergoing elective cesarean delivery at Mount Sinai Hospital under spinal anesthesia, who have given pre-operative informed written consent will be eligible to participate in this study
Who cannot join
- Patients who have refused, are unable to give or have withdrawn consent
- Patients unable to communicate fluently in English
- Patients with American Society of Anesthesiologists (ASA) classification of 3 or greater
- Patients with history of epilepsy or chronic pain, or of use of anti-epileptic drugs or neuropathic analgesic drugs
- Patients with a history of opioid or intravenous drug abuse
- Patients with a known allergy or contra-indication to gabapentin, or to any other drugs used in this trial
Show all 9Show fewer
- Patients who have refused spinal anaesthesia, or those in whom it is contra-indicated
- Patients with known congenital fetal abnormalities
- Patients who have taken antacid medication in the previous 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Perioperative Course of Gabapentin Improve Analgesia After Cesarean Delivery? A Randomised, Double-blind, Placebo Controlled Trial
Gabapentin has been very effective at treating pain after knee and hip operations, hysterectomies, and many other types of operations. A previous study at the investigators' hospital found that a single pre-operative dose of 600mg gabapentin produced a significant reduction in pain after cesarean section. However, 19% of patients complained of sedation. A subsequent study at the same institution looked to see if lowering the dose to 300mg would decrease pain scores whilst reducing the sedative side-effect seen in the first trial. The results were inconclusive but it provided valuable information to guide the design of this study.
The purpose of this study is to see whether a preoperative dose of gabapentin, followed by a 48 hour low-dose course will produce improvement in pain scores. This study will compare the efficacy of a peri-operative course of gabapentin (600mg one hour before the operation and 200mg every 8 hours for 2 days post-operatively) and a similar course of placebo in women undergoing Cesarean section. The investigators' hypothesis is that a course of gabapentin will result in decreased pain scores and increased satisfaction.
Read the detailed description
Postoperative pain can have a significant negative impact on the physical and psychological health of both mother and child after cesarean delivery. Furthermore, severe postoperative pain may lead to persistent pain for many months. Therefore, optimal prevention and treatment of post cesarean pain is of paramount importance in women's health.
The current analgesic regimen most commonly used to manage pain after cesarean delivery includes neuraxial opioids, systemic acetaminophen and nonsteroidal anti-inflammatories, and systemic opioids for breakthrough pain. Although much improvement has been made with this regimen, pain scores assessment at 24 and 48 hours post cesarean delivery still show moderate pain, so further strategies to improve pain management are warranted.
Gabapentin has been shown to reduce pain scores and opioid consumption in the post-operative period in a variety of surgical settings such as hysterectomy and mastectomy. Studies have also shown a benefit in continuing the drug as a peri-operative course.
The use of gabapentin in cesarean deliveries is limited to 2 studies. The first trial at Mount Sinai Hospital found that a single dose of 600mg of gabapentin, administered preoperatively, significantly reduced the pain and increased the level of satisfaction of mothers who had delivered by cesarean section. There was however an increase in levels of sedation seen in those who received gabapentin and so a subsequent study was designed to see whether a reduced dose of 300mg could replicate the benefits shown without making mothers as drowsy. Unfortunately this study did not allow definitive conclusions to be drawn from the results as regards analgesic benefit, however the investigators did not observe an increase in sedation in patients receiving either 300 mg or 600 mg of gabapentin. Further studies are warranted to better define the role of gabapentin in this patient population.
The purpose of this study is to evaluate the efficacy of a preoperative dose of gabapentin followed by a short course of gabapentin in the first 48 hours post cesarean delivery, in the context of a multimodal analgesic regimen inclusive of intrathecal morphine and systemic NSAIDs, acetaminophen and opioids.
We hypothesize that this regimen will decrease VAS pains scores and increase maternal satisfaction post cesarean delivery.
- Conditions
- Pain
- Being tested
- Gabapentin, lactose
- Keywords
- Gabapentin, Cesarean section
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Novo-gabapentin, Neurontin
lactoseDrug
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Active comparator | Gabapentin 600mg, 1 dose preoperatively, followed by Gabapentin 200mg tid for 5 doses. Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | lactose capsules Receives: Drug: lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score (VAS 0-100 mm) for maternal pain on movement at 24 hours after surgical incision.
Measured: 24 hours
Secondary outcomes (11)
VAS score on movement at 48 hours after surgical incision
Measured: 48 hours
VAS scores at rest at 24 and 48 hours after surgical incision
Measured: 48 hours
Maternal satisfaction scores at 24 and 48 hours after surgical incision.
Measured: 48 hours
Opioid use in the first 48 hours after surgical incision
Measured: 48 hours
Time to first analgesic
Time at which the patient requests any additional analgesic within the 48 hours after surgical incision.
Measured: 48 hours
Side effects; sedation, nausea, vomiting, dizziness, pruritis and difficulties balancing
Patients exhibiting any sedation, nausea, vomiting, dizziness, pruritis and difficulties balancing in the 48 hours after surgical incision.
Measured: 48 hours
Neonatal apgar scores
Neonatal apgars scores at 1 and 5 minutes post delivery
Measured: 5 minutes
Breastfeeding issues
The presence of any difficulties breastfeeding that requires a lactation consult while in hospital.
Measured: 48 hours
NICU admission
Any admissions to NICU of infants born to mothers participating in the study.
Measured: 48 hours
Anxiety level
Anxiety level recorded on a Numeric Rating Scale of 0-10 (0 = "no anxiety", 10 = "the most severe anxiety possible"), prior to surgery.
Measured: 5 minutes
Pain Catastrophizing Scale (PCS) questionnaire.
The PCS questionnaire is a pain research tool that examines a subject's pain related psychology.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose CA Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848119
- Sponsor's protocol ID
- 13-01
- Status last verified
- Oct 2014
- First submitted
- 2 May 2013
- Last updated
- 13 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Perioperative Course of Gabapentin Improve Analgesia After Cesarean Delivery? A Randomised, Double-blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01848119
- Acronym / sponsor ID
- 13-01
- Conditions
- Pain
- Keywords
- Gabapentin, Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 May 2013 (estimated)
- 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.
Gabapentin has been very effective at treating pain after knee and hip operations, hysterectomies, and many other types of operations. A previous study at the investigators' hospital found that a single pre-operative dose of 600mg gabapentin produced a significant reduction in pain after cesarean section. However, 19% of patients complained of sedation. A subsequent study at the same institution looked to see if lowering the dose to 300mg would decrease pain scores whilst reducing the sedative side-effect seen in the first trial. The results were inconclusive but it provided valuable information to guide the design of this study.
The purpose of this study is to see whether a preoperative dose of gabapentin, followed by a 48 hour low-dose course will produce improvement in pain scores. This study will compare the efficacy of a peri-operative course of gabapentin (600mg one hour before the operation and 200mg every 8 hours for 2 days post-operatively) and a similar course of placebo in women undergoing Cesarean section. The investigators' hypothesis is that a course of gabapentin will result in decreased pain scores and increased satisfaction.
Detailed description
Postoperative pain can have a significant negative impact on the physical and psychological health of both mother and child after cesarean delivery. Furthermore, severe postoperative pain may lead to persistent pain for many months. Therefore, optimal prevention and treatment of post cesarean pain is of paramount importance in women's health.
The current analgesic regimen most commonly used to manage pain after cesarean delivery includes neuraxial opioids, systemic acetaminophen and nonsteroidal anti-inflammatories, and systemic opioids for breakthrough pain. Although much improvement has been made with this regimen, pain scores assessment at 24 and 48 hours post cesarean delivery still show moderate pain, so further strategies to improve pain management are warranted.
Gabapentin has been shown to reduce pain scores and opioid consumption in the post-operative period in a variety of surgical settings such as hysterectomy and mastectomy. Studies have also shown a benefit in continuing the drug as a peri-operative course.
The use of gabapentin in cesarean deliveries is limited to 2 studies. The first trial at Mount Sinai Hospital found that a single dose of 600mg of gabapentin, administered preoperatively, significantly reduced the pain and increased the level of satisfaction of mothers who had delivered by cesarean section. There was however an increase in levels of sedation seen in those who received gabapentin and so a subsequent study was designed to see whether a reduced dose of 300mg could replicate the benefits shown without making mothers as drowsy. Unfortunately this study did not allow definitive conclusions to be drawn from the results as regards analgesic benefit, however the investigators did not observe an increase in sedation in patients receiving either 300 mg or 600 mg of gabapentin. Further studies are warranted to better define the role of gabapentin in this patient population.
The purpose of this study is to evaluate the efficacy of a preoperative dose of gabapentin followed by a short course of gabapentin in the first 48 hours post cesarean delivery, in the context of a multimodal analgesic regimen inclusive of intrathecal morphine and systemic NSAIDs, acetaminophen and opioids.
We hypothesize that this regimen will decrease VAS pains scores and increase maternal satisfaction post cesarean delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Active comparator | Drug: GabapentinGabapentin 600mg, 1 dose preoperatively, followed by Gabapentin 200mg tid for 5 doses. |
| Placebo | Placebo comparator | Drug: lactoselactose capsules |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All women aged 16 years and over with term singleton pregnancies undergoing elective cesarean delivery at Mount Sinai Hospital under spinal anesthesia, who have given pre-operative informed written consent will be eligible to participate in this study
Key exclusion criteria (9 listed)
- Patients who have refused, are unable to give or have withdrawn consent
- Patients unable to communicate fluently in English
- Patients with American Society of Anesthesiologists (ASA) classification of 3 or greater
- Patients with history of epilepsy or chronic pain, or of use of anti-epileptic drugs or neuropathic analgesic drugs
- Patients with a history of opioid or intravenous drug abuse
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 |
|---|---|---|
| GabapentinAlso: Novo-gabapentin, Neurontin | Drug | Gabapentin |
| lactose | Drug | Placebo |
Primary outcome
VAS score (VAS 0-100 mm) for maternal pain on movement at 24 hours after surgical incision.
Time frame: 24 hours
11 secondary outcomes
VAS score on movement at 48 hours after surgical incision
Time frame: 48 hours
VAS scores at rest at 24 and 48 hours after surgical incision
Time frame: 48 hours
Maternal satisfaction scores at 24 and 48 hours after surgical incision.
Time frame: 48 hours
Opioid use in the first 48 hours after surgical incision
Time frame: 48 hours
Time to first analgesic
Time frame: 48 hours
Side effects; sedation, nausea, vomiting, dizziness, pruritis and difficulties balancing
Time frame: 48 hours
Neonatal apgar scores
Time frame: 5 minutes
Breastfeeding issues
Time frame: 48 hours
NICU admission
Time frame: 48 hours
Anxiety level
Time frame: 5 minutes
Pain Catastrophizing Scale (PCS) questionnaire.
Time frame: 15 minutes
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 13 Oct 2014.
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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.
Jose CA Carvalho, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin and lactose in people with Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 1 inclusion and 9 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 13 Oct 2014. 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 Canada. 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?
VAS score (VAS 0-100 mm) for maternal pain on movement at 24 hours after surgical incision. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2014.