Multimodal Pain Management for Cesarean Delivery
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 3/16/2019 |
| Start Date: | October 2016 |
| End Date: | July 2017 |
Multimodal Pain Management for Cesarean Delivery: A Randomized Control Trial
Opioid use and abuse has become a major medical problem in the United States. Over
prescription of opioid medications is a major contributor to this growing problem. Cesarean
delivery (CD) is the most commonly performed surgery in the US and women are generally given
opioid medications for postoperative pain management. This is not a common practice in other
developed countries. We believe that a multimodal pain management strategy is superior to
current practices for control of postoperative pain after CD and will lead to a decrease in
the use of opioid medications. This will have beneficial effects on patients' recovery and
bonding with their newborns, as well as societal effects in reducing the burden of opioid
abuse in the US. Our objective is to investigate the use of a multimodal pain regimen in
pregnant patients undergoing CD. This is a randomized double-blinded, placebo controlled
trial. The multimodal intervention consists of a pre-operative dose of IV acetaminophen
(Ofirmev), infiltration of subcutaneous bupivacaine prior to skin incision, and a dose of IM
ketorolac at time of fascial closure. These study medications are currently used in our
patient population but not in a standardized fashion, not in every patient, and not always in
combination with each other. The control group will receive placebo IV infusion
preoperatively and an IM injection at fascial closure, and subcutaneous infiltration with
normal saline before skin incision. Both groups will receive spinal regional anesthesia as
per anesthesia team and then postoperatively, both groups will receive the current standard
of care, which consists postoperative hydrocodone/acetaminophen and ibuprofen as needed
depending on pain score. Our primary outcome of interest will be the total opioid intake in
the first 48 hours after surgery. Secondary outcomes include time to first opioid given, pain
scores at 6-12, 24 and 48 hours post op, and total number of opioid tablets left after
discharge on post op day number 7. We will also evaluate patient satisfaction scores and
total length of hospital stay. We will evaluate neonatal outcomes including Apgar scores,
cord blood gases, immediate newborn complications in the first 48 hours after birth, and any
infant adverse outcomes related to maternal opioid use up to 4 weeks of life. Our hypothesis
is that our multimodal pain regimen will decrease the total opioid requirement in the first
48 hours after surgery.
prescription of opioid medications is a major contributor to this growing problem. Cesarean
delivery (CD) is the most commonly performed surgery in the US and women are generally given
opioid medications for postoperative pain management. This is not a common practice in other
developed countries. We believe that a multimodal pain management strategy is superior to
current practices for control of postoperative pain after CD and will lead to a decrease in
the use of opioid medications. This will have beneficial effects on patients' recovery and
bonding with their newborns, as well as societal effects in reducing the burden of opioid
abuse in the US. Our objective is to investigate the use of a multimodal pain regimen in
pregnant patients undergoing CD. This is a randomized double-blinded, placebo controlled
trial. The multimodal intervention consists of a pre-operative dose of IV acetaminophen
(Ofirmev), infiltration of subcutaneous bupivacaine prior to skin incision, and a dose of IM
ketorolac at time of fascial closure. These study medications are currently used in our
patient population but not in a standardized fashion, not in every patient, and not always in
combination with each other. The control group will receive placebo IV infusion
preoperatively and an IM injection at fascial closure, and subcutaneous infiltration with
normal saline before skin incision. Both groups will receive spinal regional anesthesia as
per anesthesia team and then postoperatively, both groups will receive the current standard
of care, which consists postoperative hydrocodone/acetaminophen and ibuprofen as needed
depending on pain score. Our primary outcome of interest will be the total opioid intake in
the first 48 hours after surgery. Secondary outcomes include time to first opioid given, pain
scores at 6-12, 24 and 48 hours post op, and total number of opioid tablets left after
discharge on post op day number 7. We will also evaluate patient satisfaction scores and
total length of hospital stay. We will evaluate neonatal outcomes including Apgar scores,
cord blood gases, immediate newborn complications in the first 48 hours after birth, and any
infant adverse outcomes related to maternal opioid use up to 4 weeks of life. Our hypothesis
is that our multimodal pain regimen will decrease the total opioid requirement in the first
48 hours after surgery.
We are proposing a double-blinded, placebo controlled, randomized trial of patients
undergoing elective cesarean delivery. Participants will be randomized to either a control
group or study group. This is a double-blinded study, neither participants nor the obstetric
or anesthesia team are aware of study assignment. The study group, aka multimodal group, will
receive 1 g of IV acetaminophen (ofirmev) within 30 minutes before starting the surgery,
regional anesthesia (spinal anesthesia only) with fentanyl, duramorph (morphine) and
bupivacaine will be performed as per anesthesia team, the anticipated sight of skin incision
will be infiltrated with 20 mL of bupivacaine 0.25% in the subcutaneous space prior to skin
incision, and 60 mg of intramuscular (IM) ketorolac (toradol) will be given at the time of
fascial closure. The control group will receive a placebo drip within 30 minutes before
starting the surgery, regional anesthesia (spinal anesthesia only) with fentanyl, duramorph
(morphine) and bupivacaine will be performed as per anesthesia team, the anticipated sight of
skin incision will be infiltrated with 20 mL of normal saline in the subcutaneous space prior
to skin incision, and an IM dose of placebo at the time of fascial closure. Post-operatively
both groups will be managed similarly.
Inclusion Criteria:
- Women who are 18 - 45 years of age at the time of cesarean delivery with the ability to
give informed consent
- Elective cesarean delivery
- Gestational age ≥ 34 weeks
- Fluent in either English or Spanish
- Spinal anesthesia
Exclusion Criteria:
Urgent or emergent CD Active labor Epidural or Intrathecal regional anesthesia General
anesthesia Patients with a contraindication for regional anesthesia Acute or chronic hepatic
disease Acute or chronic renal disease Active asthma Gastrointestinal ulceration Inflammatory
bowel disease Allergy to ketorolac, acetaminophen, hydrocodone, codeine, ibuprofen or
bupivacaine Opioid dependence Non reassuring fetal or maternal status requiring immediate
delivery Placenta previa or accreta Acute or chronic pain disorder Maternal weight <50
kilograms Uncontrolled hypertension Ischemic cardiac disease Congestive heart failure
Thrombocytopenia, platelet count <150,000/microliter Preeclampsia including Hemolysis
Elevated Liver enzymes Low Platelets syndrome DIC or active hemorrhage before randomization
Estimated blood loss > 2000 mL
Primary Outcome: The primary outcome of the study is the total opioid (hydrocodone) use in
milligrams in the first 48 hours after cesarean delivery.
undergoing elective cesarean delivery. Participants will be randomized to either a control
group or study group. This is a double-blinded study, neither participants nor the obstetric
or anesthesia team are aware of study assignment. The study group, aka multimodal group, will
receive 1 g of IV acetaminophen (ofirmev) within 30 minutes before starting the surgery,
regional anesthesia (spinal anesthesia only) with fentanyl, duramorph (morphine) and
bupivacaine will be performed as per anesthesia team, the anticipated sight of skin incision
will be infiltrated with 20 mL of bupivacaine 0.25% in the subcutaneous space prior to skin
incision, and 60 mg of intramuscular (IM) ketorolac (toradol) will be given at the time of
fascial closure. The control group will receive a placebo drip within 30 minutes before
starting the surgery, regional anesthesia (spinal anesthesia only) with fentanyl, duramorph
(morphine) and bupivacaine will be performed as per anesthesia team, the anticipated sight of
skin incision will be infiltrated with 20 mL of normal saline in the subcutaneous space prior
to skin incision, and an IM dose of placebo at the time of fascial closure. Post-operatively
both groups will be managed similarly.
Inclusion Criteria:
- Women who are 18 - 45 years of age at the time of cesarean delivery with the ability to
give informed consent
- Elective cesarean delivery
- Gestational age ≥ 34 weeks
- Fluent in either English or Spanish
- Spinal anesthesia
Exclusion Criteria:
Urgent or emergent CD Active labor Epidural or Intrathecal regional anesthesia General
anesthesia Patients with a contraindication for regional anesthesia Acute or chronic hepatic
disease Acute or chronic renal disease Active asthma Gastrointestinal ulceration Inflammatory
bowel disease Allergy to ketorolac, acetaminophen, hydrocodone, codeine, ibuprofen or
bupivacaine Opioid dependence Non reassuring fetal or maternal status requiring immediate
delivery Placenta previa or accreta Acute or chronic pain disorder Maternal weight <50
kilograms Uncontrolled hypertension Ischemic cardiac disease Congestive heart failure
Thrombocytopenia, platelet count <150,000/microliter Preeclampsia including Hemolysis
Elevated Liver enzymes Low Platelets syndrome DIC or active hemorrhage before randomization
Estimated blood loss > 2000 mL
Primary Outcome: The primary outcome of the study is the total opioid (hydrocodone) use in
milligrams in the first 48 hours after cesarean delivery.
Inclusion Criteria:
- Women who are 18 - 45 years of age at the time of cesarean delivery with the ability
to give informed consent
- Elective cesarean delivery
- Gestational age ≥ 34 weeks
- Fluent in either English or Spanish
- Spinal anesthesia
Exclusion Criteria:
- Urgent or emergent CD
- Epidural or combined spinal epidural regional anesthesia
- General anesthesia
- Patients with a contraindication for regional anesthesia
- Acute or chronic hepatic disease
- Acute or chronic renal disease
- Active asthma
- Gastrointestinal ulceration
- Inflammatory bowel disease
- Allergy to ketorolac, acetaminophen, hydrocodone, codeine, ibuprofen or bupivacaine
- Opioid dependence
- Non reassuring fetal or maternal status requiring immediate delivery
- Placenta previa or accreta
- Acute or chronic pain disorder
- Maternal weight <50 kilograms
- Uncontrolled hypertension
- Ischemic cardiac disease
- Congestive heart failure
- Thrombocytopenia, platelet count <150,000/microliter
- Preeclampsia including Hemolysis Elevated Liver enzymes Low Platelets syndrome
- Disseminated intravascular coagulation (DIC) or active hemorrhage before randomization
- Estimated blood loss > 2000 mL
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University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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