Other Chronic Postoperative Pain
Conditions
Keywords
chronic pain post delivery, postpartum depression, tailored pain management
Brief summary
In previous studies the investigators have seen that the severity of pain one day after cesarean delivery can predict the presence of pain and depression 2 months later. The investigators believe those at risk for severe acute post-partum pain can be identified, and medical interventions can be tailored to manage postoperative pain more effectively.
Detailed description
This study is randomizing patients into 2 different groups and seeing if by altering our pain management with this group of patients their acute 24 hour evoked pain is less than anticipated; and the incidence of persistent pain and depression when contacted 2 months after delivery is decreased. This study is designed to see if these additional interventions would prove effective for patients at risk of having high pain level after cesarean surgery.
Interventions
DRUGDuramorph 150
Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses
DRUGAcetaminophen
Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
DRUGDuramorph 300
Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* elective cesarean section * age \>/= 18 years old * not allergic proposed study medications * predicted to experience high pain postop based on preoperative evaluation
Exclusion criteria
* allergy to study medications * known hepatic disease * weight \> 300 lbs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Acute Pain | 24 hour | to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces acute post-delivery pain (24 hour evoked pain post delivery). The scale utilized was a 100mm sliding VAS, where 0mm=no pain up to 100mm-worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Persistent Pain | 2 months | to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces persistent pain up to 2 months post delivery. |
| Pain | 24 hour | resting pain, worst pain |
| Analgesic Consumption | 24 hour | total amount of analgesic consumption |
| Incidence of Depression | 2 months | to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces postpartum depression up to 2 months post delivery. |
| Average Pain Over 24 Hours | 24 hours | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pruritus | 24 hours | side effects-percentage of subjects requiring treatment |
| Emetic Symptoms | 24hours | side effect potential with the increased dose of duramorph-percentage experiencing such symptoms |
Countries
United States
Participant flow
Recruitment details
Participants were approached during the pre-anesthesia evaluation regarding their interest in the study. Once consent was signed, subjects completed their pre-surgery questionnaires. On the day of surgery, I/E criteria were re-reviewed for confirmed enrollment for study.A total of 74 were consented with 69 randomized, with 60 completing the study.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses | 30 |
| Acetaminophen and Increased Dose of Duramorph Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incorrect use of VAS | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | not meet inclusion/exclusion criteria | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Standard of Care | Acetaminophen and Increased Dose of Duramorph | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| ASA class | 2 units on a scale | 2 units on a scale | 2 units on a scale |
| Gestational Age-weeks | 39 weeks gestation STANDARD_DEVIATION 0.3 | 39 weeks gestation STANDARD_DEVIATION 0.7 | 39 weeks gestation STANDARD_DEVIATION 0.5 |
| Height-cm | 163 cm STANDARD_DEVIATION 6 | 164 cm STANDARD_DEVIATION 6 | 163.3 cm STANDARD_DEVIATION 6 |
| Parity | 1 number previous deliveries | 1 number previous deliveries | 1 number previous deliveries |
| Previous Cesarean Section | 27 Participants | 24 Participants | 51 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight-kg | 88 kg STANDARD_DEVIATION 17 | 92 kg STANDARD_DEVIATION 19 | 89.7 kg STANDARD_DEVIATION 17.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Severity of Acute Pain
to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces acute post-delivery pain (24 hour evoked pain post delivery). The scale utilized was a 100mm sliding VAS, where 0mm=no pain up to 100mm-worst pain imaginable.
Time frame: 24 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Severity of Acute Pain | 46 mm | Standard Deviation 25 |
| Acetaminophen and Increased Dose of Duramorph | Severity of Acute Pain | 31 mm | Standard Deviation 17 |
Comparison: acute pain scores with movement at 24 hoursp-value: 0.05t-test, 2 sided
Secondary
Analgesic Consumption
total amount of analgesic consumption
Time frame: 24 hour
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard of Care | Analgesic Consumption | IV PCA morphine | 15 mg |
| Standard of Care | Analgesic Consumption | total 24 hr opioid use | 21 mg |
| Acetaminophen and Increased Dose of Duramorph | Analgesic Consumption | IV PCA morphine | 15 mg |
| Acetaminophen and Increased Dose of Duramorph | Analgesic Consumption | total 24 hr opioid use | 15 mg |
Secondary
Average Pain Over 24 Hours
Time frame: 24 hours
Population: VAS pain score of 0=no pain at all up to 100 being worst pain imaginable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Average Pain Over 24 Hours | 37 units on a scale | Standard Deviation 19 |
| Acetaminophen and Increased Dose of Duramorph | Average Pain Over 24 Hours | 23 units on a scale | Standard Deviation 14 |
Secondary
Incidence of Depression
to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces postpartum depression up to 2 months post delivery.
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Incidence of Depression | 3 Participants |
| Acetaminophen and Increased Dose of Duramorph | Incidence of Depression | 4 Participants |
Secondary
Incidence of Persistent Pain
to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces persistent pain up to 2 months post delivery.
Time frame: 2 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Incidence of Persistent Pain | 13 percentage of participants |
| Acetaminophen and Increased Dose of Duramorph | Incidence of Persistent Pain | 10 percentage of participants |
Secondary
Pain
resting pain, worst pain
Time frame: 24 hour
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard of Care | Pain | resting pain score over 24 hrs | 19 units on a scale, 0 -none, 100-worst |
| Standard of Care | Pain | worst pain score over 24 hrs | 69 units on a scale, 0 -none, 100-worst |
| Acetaminophen and Increased Dose of Duramorph | Pain | resting pain score over 24 hrs | 4 units on a scale, 0 -none, 100-worst |
| Acetaminophen and Increased Dose of Duramorph | Pain | worst pain score over 24 hrs | 62 units on a scale, 0 -none, 100-worst |
Other Pre-specified
Emetic Symptoms
side effect potential with the increased dose of duramorph-percentage experiencing such symptoms
Time frame: 24hours
Population: percentage of patients reporting emetic symptoms requiring treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Emetic Symptoms | 16 Participants |
| Acetaminophen and Increased Dose of Duramorph | Emetic Symptoms | 18 Participants |
Other Pre-specified
Pruritus
side effects-percentage of subjects requiring treatment
Time frame: 24 hours
Population: percentage of patients with pruritis requiring treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Pruritus | 15 Participants |
| Acetaminophen and Increased Dose of Duramorph | Pruritus | 21 Participants |