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Our previous work has identified the group of women at risk for prolonged pain, opioid use and poor functional recovery after childbirth. The optimal intervention to mitigate this risk is unknown. We propose to test an analgesic adjutant that is commonly used for post-operative pain compared to placebo to improve post-partum recovery.
A small percent of the large population of women who give birth have difficulty with prolonged pain, opioid use and poor functional recovery. This may be the first opiate exposure and significant health challenge in a young woman's life.
In our previous work, we have identified 20% who are at highest risk for prolonged pain and delayed opioid cessation and functional recovery with usual care. Moderate to severe pain on postpartum day 1 is a significant predictor of being in the risk group. The optimal intervention to mitigate this risk is unknown.
We plan to test an intervention of low dose gabapentin or placebo to be escalated by a pain medicine doctor as needed. We hypothesize that additional care of women predicted to be higher need by virtue of their postoperative day one pain score (> 6 x2) despite usual multimodal analgesic care will lead to reduced need for opioid, less pain and more rapid functional recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Experimental | Gabapentin 300 mg capsules will be prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist. |
|
| Control | Placebo Comparator | Matched placebo capsules will be prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Opioid Cessation as a Measure of Opioid Utilization | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Report | Number of weeks after delivery until resolution of pain as reported by participants. Pain score was averaged each week from daily reporting by participants using a numerical rating scale (range: 1-10, 1 = no pain; 10 = worst pain). | 12 weeks |
| Functional Recovery |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | PROMIS Fatigue 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes. | 12 weeks |
| Depression | PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Flood, MD, MA | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucille Packard Children's Hospital | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28926443 | Background | Komatsu R, Carvalho B, Flood PD. Recovery after Nulliparous Birth: A Detailed Analysis of Pain Analgesia and Recovery of Function. Anesthesiology. 2017 Oct;127(4):684-694. doi: 10.1097/ALN.0000000000001789. | |
| 30032880 | Background | Komatsu R, Carvalho B, Flood P. Prediction of outliers in pain, analgesia requirement, and recovery of function after childbirth: a prospective observational cohort study. Br J Anaesth. 2018 Aug;121(2):417-426. doi: 10.1016/j.bja.2018.04.033. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin | Gabapentin 300 mg capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist. |
| FG001 | Control | Matched placebo capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin | Gabapentin 300 mg capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Opioid Cessation as a Measure of Opioid Utilization | Participants who completed the protocol are included in the analysis. | Posted | Median | Inter-Quartile Range | weeks | Up to 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gabapentin | Gabapentin 300 mg capsules will be prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist. Gabapentin: Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pamela Flood, MD, MA | Stanford University | 201-370-3933 | pflood@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 11, 2020 | Sep 9, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 8, 2021 | Sep 9, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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Double blind randomized
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A randomization table will be used by the research pharmacy and study drug will be prepared in numbered bottles.
|
| Placebo | Drug | Placebo to match gabapentin |
|
Functional recovery was assessed as the number of weeks after delivery until participants reported they were able to return to pre-delivery function. |
| 12 weeks |
| 12 weeks |
| Anxiety | PROMIS Anxiety 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes. | 12 weeks |
| PROMIS Physical Function | PROMIS Physical Function questionnaire will be used to assess fatigue as a modifier of the above outcomes. | 12 weeks after delivery |
| Steps | Fitness tracker measured steps | 12 weeks after delivery |
| Sleep | Fitness tracker measured sleep | 12 weeks after delivery |
| Heart Rate | Fitness tracker measured heart rate | 12 weeks after delivery |
| 37043404 | Derived | Fowler C, Chu AW, Guo N, Ansari JR, Shafer SL, Flood PD. Outpatient Treatment With Gabapentin in Women With Severe Acute Pain After Cesarean Delivery Is Ineffective: A Randomized, Double-Blind, Placebo-Controlled Trial. Anesth Analg. 2023 Jun 1;136(6):1122-1132. doi: 10.1213/ANE.0000000000006429. Epub 2023 Apr 12. |
Matched placebo capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Pain Report | Number of weeks after delivery until resolution of pain as reported by participants. Pain score was averaged each week from daily reporting by participants using a numerical rating scale (range: 1-10, 1 = no pain; 10 = worst pain). | Participants who completed the protocol are included in the analysis. | Posted | Median | Inter-Quartile Range | weeks | 12 weeks |
|
|
|
| Secondary | Functional Recovery | Functional recovery was assessed as the number of weeks after delivery until participants reported they were able to return to pre-delivery function. | Participants who completed the protocol are included in the analysis. | Posted | Median | Inter-Quartile Range | weeks | 12 weeks |
|
|
|
| Other Pre-specified | Fatigue | PROMIS Fatigue 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes. | Not Posted | 12 weeks | Participants |
| Other Pre-specified | Depression | PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes. | Not Posted | 12 weeks | Participants |
| Other Pre-specified | Anxiety | PROMIS Anxiety 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes. | Not Posted | 12 weeks | Participants |
| Other Pre-specified | PROMIS Physical Function | PROMIS Physical Function questionnaire will be used to assess fatigue as a modifier of the above outcomes. | Not Posted | 12 weeks after delivery | Participants |
| Other Pre-specified | Steps | Fitness tracker measured steps | Not Posted | 12 weeks after delivery | Participants |
| Other Pre-specified | Sleep | Fitness tracker measured sleep | Not Posted | 12 weeks after delivery | Participants |
| Other Pre-specified | Heart Rate | Fitness tracker measured heart rate | Not Posted | 12 weeks after delivery | Participants |
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Control | Matched placebo capsules will be prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist. Placebo: Placebo to match gabapentin | 0 | 37 | 0 | 37 | 0 | 37 |
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| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |