| Registry | NCT02605187 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 160 (Actual) |
| Sponsor | Stanford University (Other) |
| Conditions | Postoperative Pain |
| Interventions | No choice given, Choice given, Ibuprofen, Acetaminophen, Gabapentin, Morphine (low), Morphine (med), Morphine (high) (Other, drug) |
| Dates | start 2015-11-01, primary completion 2017-05-22, completion 2017-05-22, first posted 2015-11-16, last updated 2018-10-16 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Postoperative Pain All trials of No choice given All trials of Choice given
The ability to predict pain and then apply modified treatment protocols has been limited. Current practice is for physicians to select standard post-operative pain treatment protocols without patient consultation. This study hopes to determine if patient's involvement in analgesic drug/dosage selection can optimize pain relief while minimizing related side effects. This could result in a more patient-centered care model and individualized perioperative analgesic treatment protocols based on patient's preferences, needs and expectations.
This randomized, controlled study will include a simple, preoperative questionnaire to obtain baseline demographic and obstetric data; and complete questions (that have previously been shown to be predictive of postoperative pain) from which we will determine their expected and target postoperative pain scores. These questionnaires should take less than 3-4 minutes to complete.
The subject will then be randomized into "choice" and "no choice" groups. The randomization for choice vs. no choice will be at a 1:3 ratio i.e. 1 woman will get no choice and 3 will get a choice for their analgesic protocol. All women will receive the same medications for intraoperative anesthetic management -- only the postoperative pain medications will be altered.
The no choice group will receive the current standard analgesic protocol: medium dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h.
The group with the choice will be offered 3 different protocols:
1\. low dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h. 2 medium dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h. 3. high dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h, as well as gabapentin po one time within 1 hr of delivery.
Women randomized to the "choice" group will select a protocol after being given a standard script explaining advantages and disadvantages of each protocol.
Drugs and doses utilized in the study are safe for postpartum women and within dose range routinely used at our and other institutions.
All breakthrough pain will be managed the same for all patients, and adequate analgesia will be available to treat post-operative pain.
Primary breakthrough rescue analgesic will be our standard oral opioid oxycodone managed using our current treatment algorithm. If pain 1-4 out of 10, 1 tablet (5 mg) will be offered, if pain >4 out of 10, 2 tablets (10 mg) will be offered PRN. Pain not responding to oral opioids will be offered IV morphine boluses or PCA as per standard treatment protocols. Additional analgesic options (e.g. TAP blocks) will also be available as per standard care.
Following standard Cesarean delivery, postoperative data will be collected (directly from patients and from the electronic medical record) by study investigators blinded to group assignment.
Outcome measures:
1. Pain scores at rest and on to sitting (VPS 0-10) collected at 3, 6, 12, 24, 36, 48 hours post-cesarean
2. Overall daily pain score and its deviation from target and expected pain score will be determined at 0-24 and >24-48 hours study periods.
3. Opioid use (oral and IV morphine) in the 0-24 and >24-48 hour study periods.
4. Time to first analgesic for breakthrough pain (minutes from spinal)
5. Side effect: Pruritus score (0-100), nausea score (0-100) and number of episodes of vomiting for the 0-24 and >24-48 hour post- operative periods
6. Any treatment of pruritus and/or nausea/vomiting
7. Satisfaction with postoperative analgesia score (0-100)
8. Discharge time (hours/minutes from surgery end)
Telephone follow-up for pain score, opioid use, and functional recovery will be performed at 1 week, 1 month, 3 months and 6 months post-Cesarean. The telephonic questions will last 3-4 minutes
| Arm | Type | Interventions | Description |
|---|---|---|---|
| No choice | Active comparator | Other: No choice given; Drug: Ibuprofen; Drug: Acetaminophen; Drug: Morphine (med) | No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h |
| Choice: low protocol | Experimental | Other: Choice given; Drug: Ibuprofen; Drug: Acetaminophen; Drug: Morphine (low) | Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h |
| Choice: medium protocol | Experimental | Other: Choice given; Drug: Ibuprofen; Drug: Acetaminophen; Drug: Morphine (med) | Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h |
| Choice: high protocol | Experimental | Other: Choice given; Drug: Ibuprofen; Drug: Acetaminophen; Drug: Gabapentin; Drug: Morphine (high) | Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose |
Sex: Female, ages: 18 Years to 50 Years
Inclusion Criteria: * Women age 18-50 * Singleton gestation * Not in active labor * Scheduled for their 1st, 2nd, or 3rd elective Cesarean * Cesarean deliveries under spinal or combined spinal epidural anesthesia (with no additional epidural doses administered) Exclusion Criteria: * History of chronic pain, anxiety, or depression * Unable to understand the concept of Verbal Numerical Pain Scale at the time of informed consent * Chronic consumption of opiates, antidepressants or anticonvulsants * Intake of opioids, NSAIDS or acetaminophen 48hrs prior to the psychophysical test * Preeclampsia (with any severe features) * Diabetes (not controlled with diet and needing drugs) * Preterm delivery (<35 weeks gestation)
| Milestone | No Choice | Choice: Low Protocol | Choice: Medium Protocol | Choice: High Protocol |
|---|---|---|---|---|
| Started | 40 | 21 | 83 | 16 |
| Completed | 32 | 19 | 72 | 15 |
| Not completed | 8 | 2 | 11 | 1 |
Time frame: Delivery to discharge (average 4 days)
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| No Choice | 0/32 (0.0%) | 0/32 (0.0%) | 3/32 (9.4%) |
| Choice: Low Protocol | 0/19 (0.0%) | 0/19 (0.0%) | 1/19 (5.3%) |
| Choice: Medium Protocol | 0/72 (0.0%) | 0/72 (0.0%) | 6/72 (8.3%) |
| Choice: High Protocol | 0/15 (0.0%) | 0/15 (0.0%) | 3/15 (20.0%) |
| Term | Organ system | No Choice | Choice: Low Protocol | Choice: Medium Protocol | Choice: High Protocol |
|---|---|---|---|---|---|
| Pain due to Bakri balloon and vag pack | Surgical and medical procedures | 1/32 | 0/19 | 0/72 | 0/15 |
| received methergine for Postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | 1/32 | 0/19 | 0/72 | 1/15 |
| Itching rash on abdomen | Skin and subcutaneous tissue disorders | 1/32 | 0/19 | 0/72 | 0/15 |
| Migrain | Nervous system disorders | 0/32 | 1/19 | 0/72 | 0/15 |
| Severe pre E diagnosed postpartum | Pregnancy, puerperium and perinatal conditions | 0/32 | 0/19 | 1/72 | 0/15 |
| misoprostol used at delivery | Pregnancy, puerperium and perinatal conditions | 0/32 | 0/19 | 1/72 | 0/15 |
| Vomit | General disorders | 0/32 | 0/19 | 1/72 | 0/15 |
| preeclampsia | Pregnancy, puerperium and perinatal conditions | 0/32 | 0/19 | 1/72 | 0/15 |
| Surrogate | General disorders | 0/32 | 0/19 | 1/72 | 0/15 |
| Urinary Tract Infections | Infections and infestations | 0/32 | 0/19 | 1/72 | 0/15 |
| Used On Q pump | General disorders | 0/32 | 0/19 | 0/72 | 1/15 |
| Extended stay | General disorders | 0/32 | 0/19 | 0/72 | 1/15 |
| Facility | City | Country | Status |
|---|---|---|---|
| Lucille Packard Children's Hospital | Palo Alto, California | United States |