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COVID-19 pandemic and competing study that took precedence
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The purpose of this study is to assess whether quadratus lumborum (QL) block performed 1 day after cesarean delivery will provide supplemental post-cesarean analgesia and reduce opioid requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Control | Sham Comparator | 20 milliliters (mL) 0.9% saline on each side |
|
| Quadratus Lumborum Block | Experimental | 20 mL solution with 0.25% bupivacaine (50 milligrams (mg)) and 3mg preservative-free dexamethasone on each side |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug | 0.9% saline on each side |
| |
| Bupivacaine |
| Measure | Description | Time Frame |
|---|---|---|
| Total opioid consumption | 48 hours after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of opioids used | at the time of intervention (one day following cesarean delivery) | |
| Amount of opioids used | 6 hours after intervention | |
| Amount of opioids used |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linden Lee, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D002045 | Bupivacaine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Drug |
0.25% bupivacaine (50mg) on each side |
|
| Dexamethasone | Drug | 3mg preservative-free dexamethasone on each side |
|
| 12 hours after intervention |
| Amount of opioids used | 24 hours after intervention |
| Amount of opioids used | 48 hours after intervention |
| Time from quadratus lumborum block until first opioid request | from time of intervention until time of first opioid request (up to 48 hours) |
| Pain as measured by an 11-point verbal pain score (at rest) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | at the time of intervention (one day following cesarean delivery) |
| Pain as measured by an 11-point verbal pain score (with movement) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | at the time of intervention (one day following cesarean delivery) |
| Pain as measured by an 11-point verbal pain score (at rest) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 6 hours after intervention |
| Pain as measured by an 11-point verbal pain score (with movement) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 6 hours after intervention |
| Pain as measured by an 11-point verbal pain score (at rest) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 12 hours after intervention |
| Pain as measured by an 11-point verbal pain score (with movement) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 12 hours after intervention |
| Pain as measured by an 11-point verbal pain score (at rest) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 24 hours after intervention |
| Pain as measured by an 11-point verbal pain score (with movement) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 24 hours after intervention |
| Pain as measured by an 11-point verbal pain score (at rest) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 48 hours after intervention |
| Pain as measured by an 11-point verbal pain score (with movement) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 48 hours after intervention |
| Nausea as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | at the time of intervention (one day following cesarean delivery) |
| Nausea as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 6 hours after intervention |
| Nausea as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 12 hours after intervention |
| Nausea, pruritus and sedation as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 24 hours after intervention |
| Nausea as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 48 hours after intervention |
| Pruritus as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | at the time of intervention (one day following cesarean delivery) |
| Pruritus as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 6 hours after intervention |
| Pruritus as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 12 hours after intervention |
| Pruritus as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 24 hours after intervention |
| Pruritus as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 48 hours after intervention |
| Sedation as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | at the time of intervention (one day following cesarean delivery) |
| Sedation as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 6 hours after intervention |
| Sedation as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 12 hours after intervention |
| Sedation as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 24 hours after intervention |
| Sedation as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 48 hours after intervention |
| Patient satisfaction as measured by the 5-point Likert scale | The 5-point scale ranges from extremely satisfied to not satisfied. | 48 hours after intervention |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D017670 |
| Sodium Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |