PainNCT01094925
The Effectiveness of Gabapentin for Post-operative Pain Following Cesarean Section
A study testing lactose, Gabapentin 300mg and Gabapentin 600mg 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 caesarean section. 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?
- lactose, Gabapentin 300mg and Gabapentin 600mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Feb 2011
- 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
- 18 years or older
- full term singleton pregnancy
- undergoing elective cesarean delivery
Who cannot join
- 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
- 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: The Effectiveness of a Pre-operative Single Dose Administration of Gabapentin for Management of Post-operative Pain Following Cesarean Section: a Randomised, Double-blind, Placebo-controlled, Dose-finding Study
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 caesarean section. However, 19% complained of sedation. The purpose of this study is to see whether a reduced dose of gabapentin will produce a similar improvement in pain scores while avoiding adverse effects such as sedation or dizziness. The objective of this study is to compare the efficacy of a single pre-operative oral dose of gabapentin 300mg, versus 600mg and placebo in women undergoing Cesarean section. The investigators' hypothesis is that gabapentin 300mg will result in decreased pain scores similar to gabapentin 600mg, but with reduced side effects.
Read the detailed description
Post-operative pain is the greatest fear of women who undergo Cesarean section, and despite current analgesic regimens, this pain can be severe, impeding the mother's recovery and her ability to bond with and breastfeed her new infant. Opioids are the mainstay of treatment currently, and, although effective, these drugs have significant adverse effects, including sedation, nausea, vomiting and constipation. Non-steroidal anti-inflammatory drugs (NSAIDs) can reduce opioid consumption, but also have side effects, and are contra-indicated in a significant number of patients. Therefore there remains considerable scope to improve post-Cesarean analgesia.
It has been shown that severe acute post-operative pain after Cesarean section increases the risk of developing chronic pain and post-partum depression. A recent study showed that up to 18% of women have persistent pain after Cesarean section, and that severe acute post-operative pain is a significant risk factor.
Gabapentin is used widely to treat chronic pain, and has been demonstrated to be effective at treating acute post-operative pain following a variety of surgical procedures, with significant reductions in opioid consumption. Side effects are uncommon; the most likely are dizziness and sedation. Gabapentin does cross the placenta and into breast milk, but there is no evidence of adverse maternal or neonatal effects in women taking gabapentin during pregnancy. Gabapentin has been used successfully to treat pain in neonates.
A recent study at Mount Sinai Hospital compared a single pre-operative dose of 600mg gabapentin versus placebo in women undergoing Cesarean section. Women in the gabapentin group reported significantly improved pain scores on movement up to 48 hours after surgery. Side effects were similar in both groups apart from an increase in somnolence in the gabapentin group.
The objective of this study is to compare the efficacy of a single pre-operative oral dose of gabapentin 300mg, versus 600mg and placebo in women undergoing Cesarean section. Our hypothesis is that gabapentin 300mg will result in decreased pain scores similar to gabapentin 600mg, but with reduced side effects. We have designed a randomized, double-blind, placebo-controlled study which will aim to answer these questions. Aside from the administration of gabapentin one hour prior to surgery, there are no other changes to the standard protocol of anaesthetic care. Women will be followed up for 48 hours after surgery for assessment of pain scores and overall satisfaction. A further follow-up at three months will determine the incidence of chronic pain.
Few studies have examined the incidence of chronic pain following Cesarean section, and none have examined the impact of pre-emptive analgesia using gabapentin on the incidence of chronic pain following Cesarean section. As the rate of Cesarean section continues to increase, and there remain significant problems with current analgesic regimens, the use of gabapentin, a drug with proven effectiveness in post-surgical pain and with limited side effects, has the potential to considerably improve acute and chronic post-Cesarean pain, and lead to a widespread change in clinical practice.
- Conditions
- Pain
- Being tested
- lactose, Gabapentin 300mg, Gabapentin 600mg
- 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.
lactoseDrug
Single oral dose
Gabapentin 300mgDrug
Also called Novo-gabapentin, Neurontin
Single oral dose of 300mg gabapentin
Gabapentin 600mgDrug
Also called Novo-gabapentin, Neurontin
Single oral dose of 600mg gabapentin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: lactose |
| Gabapentin 300mg | Active comparator | Not described Receives: Drug: Gabapentin 300mg |
| Gabapentin 600mg | Active comparator | Not described Receives: Drug: Gabapentin 600mg |
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 (6)
Pain at rest and on movement by VAS, and maternal satisfaction at 6, 12, 24 & 48 hours postoperatively
Measured: 48 hours
Opioid consumption at 6, 12, 24 & 48 hours postoperatively
Measured: 48 hours
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, need for neonatal intensive care unit (NICU) admission
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionFeb 2011
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
- 126 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
- NCT01094925
- Sponsor's protocol ID
- 10-01
- Status last verified
- Feb 2011
- First submitted
- 25 Mar 2010
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Pre-operative Single Dose Administration of Gabapentin for Management of Post-operative Pain Following Cesarean Section: a Randomised, Double-blind, Placebo-controlled, Dose-finding Study
- ClinicalTrials.gov ID
- NCT01094925
- Acronym / sponsor ID
- 10-01
- Conditions
- Pain
- Keywords
- Cesarean section, Gabapentin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 29 Mar 2010 (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 caesarean section. However, 19% complained of sedation. The purpose of this study is to see whether a reduced dose of gabapentin will produce a similar improvement in pain scores while avoiding adverse effects such as sedation or dizziness. The objective of this study is to compare the efficacy of a single pre-operative oral dose of gabapentin 300mg, versus 600mg and placebo in women undergoing Cesarean section. The investigators' hypothesis is that gabapentin 300mg will result in decreased pain scores similar to gabapentin 600mg, but with reduced side effects.
Detailed description
Post-operative pain is the greatest fear of women who undergo Cesarean section, and despite current analgesic regimens, this pain can be severe, impeding the mother's recovery and her ability to bond with and breastfeed her new infant. Opioids are the mainstay of treatment currently, and, although effective, these drugs have significant adverse effects, including sedation, nausea, vomiting and constipation. Non-steroidal anti-inflammatory drugs (NSAIDs) can reduce opioid consumption, but also have side effects, and are contra-indicated in a significant number of patients. Therefore there remains considerable scope to improve post-Cesarean analgesia.
It has been shown that severe acute post-operative pain after Cesarean section increases the risk of developing chronic pain and post-partum depression. A recent study showed that up to 18% of women have persistent pain after Cesarean section, and that severe acute post-operative pain is a significant risk factor.
Gabapentin is used widely to treat chronic pain, and has been demonstrated to be effective at treating acute post-operative pain following a variety of surgical procedures, with significant reductions in opioid consumption. Side effects are uncommon; the most likely are dizziness and sedation. Gabapentin does cross the placenta and into breast milk, but there is no evidence of adverse maternal or neonatal effects in women taking gabapentin during pregnancy. Gabapentin has been used successfully to treat pain in neonates.
A recent study at Mount Sinai Hospital compared a single pre-operative dose of 600mg gabapentin versus placebo in women undergoing Cesarean section. Women in the gabapentin group reported significantly improved pain scores on movement up to 48 hours after surgery. Side effects were similar in both groups apart from an increase in somnolence in the gabapentin group.
The objective of this study is to compare the efficacy of a single pre-operative oral dose of gabapentin 300mg, versus 600mg and placebo in women undergoing Cesarean section. Our hypothesis is that gabapentin 300mg will result in decreased pain scores similar to gabapentin 600mg, but with reduced side effects. We have designed a randomized, double-blind, placebo-controlled study which will aim to answer these questions. Aside from the administration of gabapentin one hour prior to surgery, there are no other changes to the standard protocol of anaesthetic care. Women will be followed up for 48 hours after surgery for assessment of pain scores and overall satisfaction. A further follow-up at three months will determine the incidence of chronic pain.
Few studies have examined the incidence of chronic pain following Cesarean section, and none have examined the impact of pre-emptive analgesia using gabapentin on the incidence of chronic pain following Cesarean section. As the rate of Cesarean section continues to increase, and there remain significant problems with current analgesic regimens, the use of gabapentin, a drug with proven effectiveness in post-surgical pain and with limited side effects, has the potential to considerably improve acute and chronic post-Cesarean pain, and lead to a widespread change in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: lactose |
| Gabapentin 300mg | Active comparator | Drug: Gabapentin 300mg |
| Gabapentin 600mg | Active comparator | Drug: Gabapentin 600mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 years or older
- full term singleton pregnancy
- undergoing elective cesarean delivery
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| lactoseSingle oral dose | Drug | Placebo |
| Gabapentin 300mgAlso: Novo-gabapentin, NeurontinSingle oral dose of 300mg gabapentin | Drug | Gabapentin 300mg |
| Gabapentin 600mgAlso: Novo-gabapentin, NeurontinSingle oral dose of 600mg gabapentin | Drug | Gabapentin 600mg |
Primary outcome
Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively
Time frame: 24 hours
6 secondary outcomes
Pain at rest and on movement by VAS, and maternal satisfaction at 6, 12, 24 & 48 hours postoperatively
Time frame: 48 hours
Opioid consumption at 6, 12, 24 & 48 hours postoperatively
Time frame: 48 hours
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, need for neonatal intensive care unit (NICU) admission
Time frame: 48 hours
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 23 Feb 2011.
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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 lactose, Gabapentin 300mg and Gabapentin 600mg 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 3 inclusion and 8 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 23 Feb 2011. 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?
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 23 Feb 2011.