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limited resources for recruitment
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Comparison of standard post-operative cesarean surgery pain management with regional post-op pain control.
The purpose of this trial is to determine the efficacy of a postoperative analgesia strategy that incorporates quadratus lumborum block (QLB) in conjunction with a multi-modal post-cesarean analgesia strategy. The investigators hypothesize that QLB will provide superior post-cesarean analgesia compared to the current standard of care, multi-modal analgesia.
Thus, analgesia following cesarean section using QLB compared to the current standard of care alone will be further investigated. Current practice for cesarean surgical intervention consists of multi-modal analgesia (i.e., Intrathecal morphine (ITM) and scheduled post-operative non-opioid oral analgesics, with oral opioid analgesics reserved for breakthrough pain).
Investigators will measure side-effects associated with each strategy: Standard of care methods consisting of intrathecal morphine (ITM) plus scheduled non-opioid analgesics in conjunction with prn opioid analgesics for breakthrough pain will be utilized for both. The experimental treatment arm will entail standard of care in addition to QLB. The sham comparator will entail standard of care in addition to QLB with saline.
For each strategy, we will measure and model associated economic ramifications; such factors will include drug costs, procedure costs, and costs associated with length of stay and re-admissions.
The quadratus lumborum block (QLB) is similar to the transversus abdominis plane (TAP) block, but differs slightly in regards to the anatomical region where local anesthetic is injected. Since the quadratus lumborum (QL) is more posteriorly located, it theoretically confers greater safety due to enhanced visualization. The TAP block has been studied extensively for post-cesarean delivery pain, consistently showing that it is not superior to ITM for post-operative analgesia; however, it may prove to be helpful in patients with breakthrough pain despite the use of ITM, or in patients who were unable to receive ITM (e.g. general anesthesia for cesarean, contraindications to neuraxial morphine). Thus, ITM is superior to TAP alone for post-cesarean analgesia, but it is associated with a dose-dependent increased risk for opioid related side effects. In 2015, Blanco et. al. published a study specifically using the QLB for postoperative pain after cesarean delivery. In this study, they compared a true QLB to a sham QLB all in patients who did not receive ITM, and found that the QLB provided improved pain control and decreased the need for post-operative opioids. Another study in 2016 demonstrated that the QLB is superior to the TAP block in regards to decreasing post-operative pain following c-section. Unfortunately, neither study compared the QLB to ITM (part of the current gold standard for post-cesarean delivery pain, multimodal analgesia).
The gap in knowledge regarding the utility of QLB as part of a multimodal analgesic approach including ITM for cesarean section warrants further investigation. Clinicians are constantly searching for methods to provide patients with the most effective medical interventions that provide maximal benefit and minimal harm. Post-operative pain control following cesarean delivery is an area that is important to patients and to providers, and the introduction of the QLB for this purpose has the potential to improve analgesic benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITM + Sham QLB | Sham Comparator | Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section. |
|
| ITM + Bupivacaine QLB | Experimental | Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITM + Sham QLB | Drug | Sham subcutaneous non-anesthetic infiltration with saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Score With Movement | Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible. | 24 hours after surgical procedure (cesarean delivery) |
| Measure | Description | Time Frame |
|---|---|---|
| Breast Feeding Success/Quality | Limited breastfeeding resulting from pain or opioid side effects | 24-hours post-operatively |
| Visual Analogue Scale (VAS) Pain Score at Rest | VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible. |
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Inclusion Criteria:
Exclusion Criteria:
pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Amy Monroe | University of Pittsburgh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Women's Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
No plans to share
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| ID | Title | Description |
|---|---|---|
| FG000 | ITM + Sham QLB | Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section. ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline |
| FG001 | ITM + Bupivacaine QLB | Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section. ITM + Bupivacaine QLB: QL plane block with local anesthesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ITM + Sham QLB | Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section. ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline |
| BG001 | ITM + Bupivacaine QLB |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Visual Analogue Scale (VAS) Pain Score With Movement | Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible. | Posted | Mean | Standard Deviation | Units on a scale | 24 hours after surgical procedure (cesarean delivery) |
|
Time of consent up to 48-hours post-operative
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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 | ITM + Sham QLB | Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section. ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicholas Schott, MD | UPMC | 412-692-4503 | schottnj@upmc.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 | Aug 14, 2017 | Feb 14, 2024 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 14, 2017 | Feb 14, 2024 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 18, 2019 | Feb 14, 2024 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C111653 | SLC22A18 protein, human |
| D012965 | Sodium Chloride |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| ITM + Bupivacaine QLB | Drug | QL plane block with local anesthesia |
|
|
| 1 hour after intervention |
| First Request for Pain Medication | Time to first opioid dose (measured in hours) | From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours |
| Sedation | Presence or absence will be noted. Will be measured via Ramsay Sedation Score which ranges on a scale of 1 to 6 as follows: 1-patient is anxious, agitated, or restless. 2-patient is co-operative and oriented. 3-patient responds to commands only. 4-patient exhibits brisk response to light stimuli or loud auditory stimuli. 5-patient exhibits sluggish response to light or auditory stimuli. 6-patient exhibits no response. | 24-hours post-operative |
| Pruritis | Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching | 4-hours post-operative |
| Nausea/Vomiting | Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment | 4-hours post-operative |
| Systolic Blood Pressure | Will be measured in mmHG per standard of care and documented by study staff. | 4-hours post-operative |
| Respiratory Rate | Will be measured in rate/min per standard of care and documented by study staff | 4-hours post-operative |
| Oxygen Saturation | Will be measured in % per standard of care and documented by study staff | 4-hours post-operative |
| Visual Analogue Scale (VAS) Pain Score at Rest | VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible. | 4 hours after intervention |
| Visual Analogue Scale (VAS) Pain Score at Rest | VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible. | 24 hours after intervention |
| Visual Analogue Scale (VAS) Pain Score at Rest | VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible. | 48 hours after intervention |
| Pruritis | Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching | 24-hours post-operative |
| Pruritis | Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching | 48-hours post-operative |
| Nausea/Vomiting | Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment | 24-hours post-operative |
| Nausea/Vomiting | Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment | 48-hours post-operative |
| Heart Rate | Standard heart rate obtained | 4-hours post-operative |
| Heart Rate | Standard heart rate obtained | 24-hours post-operative |
| Heart Rate | Standard heart rate obtained | 48-hours post-operative |
| Systolic Blood Pressure | Will be measured in mmHG per standard of care and documented by study staff. | 24-hours post-operative |
| Systolic Blood Pressure | Will be measured in mmHG per standard of care and documented by study staff. | 48-hours post-operative |
| Diastolic Blood Pressure | Will be measured in mmHG per standard of care and documented by study staff. | 4-hours post-operative |
| Diastolic Blood Pressure | Will be measured in mmHG per standard of care and documented by study staff. | 24-hours post-operative |
| Diastolic Blood Pressure | Will be measured in mmHG per standard of care and documented by study staff. | 48-hours post-operative |
| Respiratory Rate | Will be measured in rate/min per standard of care and documented by study staff | 24-hours post-operative |
| Respiratory Rate | Will be measured in rate/min per standard of care and documented by study staff | 48-hours post-operative |
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section. ITM + Bupivacaine QLB: QL plane block with local anesthesia |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gravidity | Mean | Standard Deviation | Number of pregnancies |
|
| Parity | Number of births with a gestational age of 24 weeks or more | Mean | Standard Deviation | Number of births |
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|
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| Secondary | Breast Feeding Success/Quality | Limited breastfeeding resulting from pain or opioid side effects | This data was not collected during the duration of this study. | Posted | 24-hours post-operatively |
|
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| Secondary | Visual Analogue Scale (VAS) Pain Score at Rest | VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible. | Data was not collected at the specified timepoint for this outcome. | Posted | 1 hour after intervention |
|
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| Secondary | First Request for Pain Medication | Time to first opioid dose (measured in hours) | Posted | Mean | Standard Deviation | Hours | From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours |
|
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| Secondary | Sedation | Presence or absence will be noted. Will be measured via Ramsay Sedation Score which ranges on a scale of 1 to 6 as follows: 1-patient is anxious, agitated, or restless. 2-patient is co-operative and oriented. 3-patient responds to commands only. 4-patient exhibits brisk response to light stimuli or loud auditory stimuli. 5-patient exhibits sluggish response to light or auditory stimuli. 6-patient exhibits no response. | Posted | Count of Participants | Participants | 24-hours post-operative |
|
|
|
| Secondary | Pruritis | Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching | Posted | Count of Participants | Participants | 4-hours post-operative |
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|
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| Secondary | Nausea/Vomiting | Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment | Posted | Count of Participants | Participants | 4-hours post-operative |
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| Secondary | Systolic Blood Pressure | Will be measured in mmHG per standard of care and documented by study staff. | Posted | Mean | Standard Deviation | mmHg | 4-hours post-operative |
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| Secondary | Respiratory Rate | Will be measured in rate/min per standard of care and documented by study staff | Posted | Mean | Standard Deviation | Breaths/minute | 4-hours post-operative |
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| Secondary | Oxygen Saturation | Will be measured in % per standard of care and documented by study staff | Posted | Mean | Standard Deviation | percentage of SpO2 | 4-hours post-operative |
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| Secondary | Visual Analogue Scale (VAS) Pain Score at Rest | VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible. | Posted | Mean | Standard Deviation | units on a scale | 4 hours after intervention |
|
|
|
| Secondary | Visual Analogue Scale (VAS) Pain Score at Rest | VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible. | Posted | Mean | Standard Deviation | units on a scale | 24 hours after intervention |
|
|
|
| Secondary | Visual Analogue Scale (VAS) Pain Score at Rest | VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible. | Posted | Mean | Standard Deviation | units on a scale | 48 hours after intervention |
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|
|
| Secondary | Pruritis | Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching | Posted | Count of Participants | Participants | 24-hours post-operative |
|
|
|
| Secondary | Pruritis | Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching | Posted | Count of Participants | Participants | 48-hours post-operative |
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| Secondary | Nausea/Vomiting | Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment | Posted | Count of Participants | Participants | 24-hours post-operative |
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| Secondary | Nausea/Vomiting | Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment | Posted | Count of Participants | Participants | 48-hours post-operative |
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| Secondary | Heart Rate | Standard heart rate obtained | Posted | Mean | Standard Deviation | Heartbeats/minute | 4-hours post-operative |
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| Secondary | Heart Rate | Standard heart rate obtained | Posted | Mean | Standard Deviation | Heartbeats/minute | 24-hours post-operative |
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| Secondary | Heart Rate | Standard heart rate obtained | Posted | Mean | Standard Deviation | Heartbeats/minute | 48-hours post-operative |
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| Secondary | Systolic Blood Pressure | Will be measured in mmHG per standard of care and documented by study staff. | Posted | Mean | Standard Deviation | mmHg | 24-hours post-operative |
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| Secondary | Systolic Blood Pressure | Will be measured in mmHG per standard of care and documented by study staff. | Posted | Mean | Standard Deviation | mmHg | 48-hours post-operative |
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| Secondary | Diastolic Blood Pressure | Will be measured in mmHG per standard of care and documented by study staff. | Posted | Mean | Standard Deviation | mmHg | 4-hours post-operative |
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| Secondary | Diastolic Blood Pressure | Will be measured in mmHG per standard of care and documented by study staff. | Posted | Mean | Standard Deviation | mmHg | 24-hours post-operative |
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| Secondary | Diastolic Blood Pressure | Will be measured in mmHG per standard of care and documented by study staff. | Posted | Mean | Standard Deviation | mmHg | 48-hours post-operative |
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| Secondary | Respiratory Rate | Will be measured in rate/min per standard of care and documented by study staff | Posted | Mean | Standard Deviation | Breaths/minute | 24-hours post-operative |
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| Secondary | Respiratory Rate | Will be measured in rate/min per standard of care and documented by study staff | Posted | Mean | Standard Deviation | Breaths/minute | 48-hours post-operative |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | ITM + Bupivacaine QLB | Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section. ITM + Bupivacaine QLB: QL plane block with local anesthesia | 0 | 11 | 0 | 11 | 0 | 11 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D017670 |
| Sodium Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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