PainNCT00573664
The Effectiveness and Safety of Gabapentin for Post-operative Pain After Cesarean Section
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
The purpose of this study is to determine whether a single dose of gabapentin, given before cesarean section, will reduce pain in the initial 24 hours after surgery. Gabapentin has been very effective at treating pain after knee and hip operations, hysterectomies, and many other types of surgeries. Read more about this study
- Who is it for?
- Ages 18 to 50 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
- 46 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Feb 2009
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women undergoing elective cesarean delivery
Who cannot join
- Patients unable to communicate in English
- Patients with an American Society of Anesthesiologists (ASA) classification of 3 or higher
- Patients with contraindications to any of the medications used in the study
- Patients with contraindications to spinal anesthesia
- Patients who have taken any pain medication in the past week
- Patients with fetuses having congenital abnormalities
Show all 11Show fewer
- Patients with severe mental disorders
- Patients with HIV or hepatitis infections
- Intravenous drug users
- Patients with uncontrolled hypertension and diabetes
- Patients with central nervous system tumours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness and Safety of Gabapentin for Post-operative Pain After Cesarean Section: A Randomized Placebo-controlled Trial
The purpose of this study is to determine whether a single dose of gabapentin, given before cesarean section, will reduce pain in the initial 24 hours after surgery. Gabapentin has been very effective at treating pain after knee and hip operations, hysterectomies, and many other types of surgeries. We believe that it may be effective for treating pain after cesarean sections, but it has never been studied for this purpose.
Read the detailed description
A cesarean section is a surgical procedure and, like all surgeries, there is pain after the operation. The purpose of this study is to find out if patients have less pain after a cesarean delivery when they receive a single dose of a gabapentin before the surgery. We are also interested in whether or not the dose of gabapentin reduces the need for other pain-killing medication during this time.
Patients will be randomly assigned to receive either gabapentin or a placebo. In addition, all patients will receive the usual standard of care and medication for pain (intrathecal morphine,oral paracetamol and diclofenac). At 4, 12, 24 and 48 hours after the operation, patients will be asked about their pain and satisfaction with pain management. The dose of gabapentin given is thought to be safe for the baby, and we plan to investigate whether the gabapentin has any effect on the baby's pain response when given his/her vitamin K injection. Gabapentin has also been shown to reduce long-term pain that can develop, and patients will be followed up at 6 weeks to be asked about their pain at that time.
- Conditions
- Pain
- Being tested
- Gabapentin, lactose
- Keywords
- Cesarean section, Gabapentin
- 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 Neurontin
single oral dose of 600mg gabapentin
lactoseOther
Single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Gabapentin Receives: Drug: Gabapentin |
| 2 | Placebo comparator | Placebo Receives: Other: lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.
Measured: 24 hours
Secondary outcomes (8)
Pain at rest and on movement by VAS at 4, 12, 24 & 48 hours postoperatively.
Measured: 48
Opioid consumption at 4, 12, 24 & 48 hours postoperatively.
Measured: 48
Assessment of sedation, pruritis, nausea, vomiting and dizziness on a 4-point scale (absent, mild, moderate, severe) and document treatment if required.
Measured: 48 hours
Time to first maternal request for supplemental analgesia.
Measured: 48 hours
Presence of pain 3 months postoperatively.
Measured: 3 months
Neonatal information: Apgar scores, arterial cord blood gases, arterial and venous cord blood gabapentin concentration, need for NICU admission
Measured: 48 hours
Neonatal pain response at vitamin K injection (0-100%)
Measured: 1 hour
Maternal gabapentin levels (25 patients)
Measured: 6 months (samples will be stored and sent together)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2008
- Study completionFeb 2009
Why it stopped: Interim analysis showed a significant reduction in the pain scores
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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jose CA Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573664
- Sponsor's protocol ID
- 07-10
- Other IDs
- 07-0242-A
- Status last verified
- Jul 2009
- First submitted
- 12 Dec 2007
- Last updated
- 30 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Gabapentin for Post-operative Pain After Cesarean Section: A Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00573664
- Acronym / sponsor ID
- 07-10
- Conditions
- Pain
- Keywords
- Cesarean section, Gabapentin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed a significant reduction in the pain scores
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 14 Dec 2007 (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.
The purpose of this study is to determine whether a single dose of gabapentin, given before cesarean section, will reduce pain in the initial 24 hours after surgery. Gabapentin has been very effective at treating pain after knee and hip operations, hysterectomies, and many other types of surgeries. We believe that it may be effective for treating pain after cesarean sections, but it has never been studied for this purpose.
Detailed description
A cesarean section is a surgical procedure and, like all surgeries, there is pain after the operation. The purpose of this study is to find out if patients have less pain after a cesarean delivery when they receive a single dose of a gabapentin before the surgery. We are also interested in whether or not the dose of gabapentin reduces the need for other pain-killing medication during this time.
Patients will be randomly assigned to receive either gabapentin or a placebo. In addition, all patients will receive the usual standard of care and medication for pain (intrathecal morphine,oral paracetamol and diclofenac). At 4, 12, 24 and 48 hours after the operation, patients will be asked about their pain and satisfaction with pain management. The dose of gabapentin given is thought to be safe for the baby, and we plan to investigate whether the gabapentin has any effect on the baby's pain response when given his/her vitamin K injection. Gabapentin has also been shown to reduce long-term pain that can develop, and patients will be followed up at 6 weeks to be asked about their pain at that time.
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 |
|---|---|---|
| 1 | Active comparator | Drug: GabapentinGabapentin |
| 2 | Placebo comparator | Other: lactosePlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women undergoing elective cesarean delivery
Key exclusion criteria (11 listed)
- Patients unable to communicate in English
- Patients with an American Society of Anesthesiologists (ASA) classification of 3 or higher
- Patients with contraindications to any of the medications used in the study
- Patients with contraindications to spinal anesthesia
- Patients who have taken any pain medication in the past week
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: Neurontinsingle oral dose of 600mg gabapentin | Drug | 1 |
| lactoseSingle dose | Other | 2 |
Primary outcome
Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.
Time frame: 24 hours
8 secondary outcomes
Pain at rest and on movement by VAS at 4, 12, 24 & 48 hours postoperatively.
Time frame: 48
Opioid consumption at 4, 12, 24 & 48 hours postoperatively.
Time frame: 48
Assessment of sedation, pruritis, nausea, vomiting and dizziness on a 4-point scale (absent, mild, moderate, severe) and document treatment if required.
Time frame: 48 hours
Time to first maternal request for supplemental analgesia.
Time frame: 48 hours
Presence of pain 3 months postoperatively.
Time frame: 3 months
Neonatal information: Apgar scores, arterial cord blood gases, arterial and venous cord blood gabapentin concentration, need for NICU admission
Time frame: 48 hours
Neonatal pain response at vitamin K injection (0-100%)
Time frame: 1 hour
Maternal gabapentin levels (25 patients)
Time frame: 6 months (samples will be stored and sent together)
Results and safety
The study was stopped early (reason given: Interim analysis showed a significant reduction in the pain scores). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2009.
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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 11 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: stopped early, as of the sponsor's last update on 30 Jul 2009. 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 was stopped early (reason given: Interim analysis showed a significant reduction in the pain scores). Results are not available in the source record.
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?
Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively. (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 30 Jul 2009.