Trial Outcomes & Findings for Intrathecal Hydromorphone for Pain Control After Cesarean Section (NCT NCT02096003)

NCT ID: NCT02096003

Last Updated: 2019-08-20

Results Overview

Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 80 participants
• Primary outcome timeframe: at 24 hours
• Results posted on: 2019-08-20

Participant Flow

Recruitment began in April 2014 with enrollment from May 2014 to May 2017

Participant milestones

Measure	Intrathecal Morphine 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections Intrathecal morphine: 0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm.	Intrathecal Hydromorphone 50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections. Intrathecal hydromorphone: 50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia.
Overall Study STARTED	40	40
Overall Study COMPLETED	38	37
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Intrathecal Morphine 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections Intrathecal morphine: 0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm.	Intrathecal Hydromorphone 50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections. Intrathecal hydromorphone: 50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia.
Overall Study Protocol Violation	0	2
Overall Study additional surgery	2	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intrathecal Morphine n=38 Participants 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections	Intrathecal Hydromorphone n=37 Participants 50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.	Total n=75 Participants Total of all reporting groups
Age, Continuous	34.5 years STANDARD_DEVIATION 5.1 • n=38 Participants	33.75 years STANDARD_DEVIATION 4.1 • n=37 Participants	34.1 years STANDARD_DEVIATION 4.3 • n=75 Participants
Sex: Female, Male Female	38 Participants n=38 Participants	37 Participants n=37 Participants	75 Participants n=75 Participants
Sex: Female, Male Male	0 Participants n=38 Participants	0 Participants n=37 Participants	0 Participants n=75 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: at 24 hours

Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op.

Outcome measures

Measure	Intrathecal Morphine n=38 Participants 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections	Intrathecal Hydromorphone n=37 Participants 50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.
Post Operative Fentanyl PCA Consumption	300 µg Standard Deviation 432	446 µg Standard Deviation 440

SECONDARY outcome

Timeframe: up to 24 hours

Population: data not collected.

When does the patient need to use the PCA for the first time? This will be used to assess when morphine and hydromorphone first begin to provide analgesia.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 24 hours

Assess pain scores on a scale of 1-5, with higher score indicating more pain.

Outcome measures

Measure	Intrathecal Morphine n=38 Participants 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections	Intrathecal Hydromorphone n=37 Participants 50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.
Pain Score	4.8 score on a scale Interval 1.0 to 5.0	4.7 score on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: at 24 hours

Patient satisfaction score - total scale of 1-5, with higher score indicating more satisfaction

Outcome measures

Measure	Intrathecal Morphine n=38 Participants 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections	Intrathecal Hydromorphone n=37 Participants 50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.
Patient Satisfaction Score	4.8 score on a scale Interval 1.0 to 5.0	4.6 score on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: up to 24 hours

Symptom scale for nausea and pruritus. Full scale from 1-5, with higher score indicating more symptoms.

Outcome measures

Measure	Intrathecal Morphine n=38 Participants 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections	Intrathecal Hydromorphone n=37 Participants 50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.
Symptom Scale for Two Specific Side Effects of Nausea and Pruritus Pruritus	3.8 score on a scale Interval 1.0 to 5.0	4 score on a scale Interval 1.0 to 5.0
Symptom Scale for Two Specific Side Effects of Nausea and Pruritus Nausea	4.4 score on a scale Interval 1.0 to 5.0	4.7 score on a scale Interval 1.0 to 5.0

Adverse Events

Intrathecal Morphine

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Intrathecal Hydromorphone

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intrathecal Morphine n=40 participants at risk 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections	Intrathecal Hydromorphone n=40 participants at risk 50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.
General disorders Nausea	5.0% 2/40 • up to 24 hours	7.5% 3/40 • up to 24 hours
Skin and subcutaneous tissue disorders Puritus	85.0% 34/40 • up to 24 hours	80.0% 32/40 • up to 24 hours

Additional Information

Dr. Yaakov Beilin

Icahn School of Medicine at Mount Sinai

Phone: 212-241-7467

Email: yaakov.beilin@mountsinai.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place