Trial Outcomes & Findings for Mu-Opioid Receptor Genetic Polymorphism and Intrathecal Analgesia (NCT NCT00418015)

Results Overview

Time from intrathecal drug administration to request for analgesia either in laboring women of after cesarean delivery

Recruitment status

COMPLETED

Target enrollment

293 participants

Primary outcome timeframe

Time (0-1440 minutes) to first analgesia request

Results posted on

2014-04-14

Participant Flow

Laboring subject recruited from 10/2005 to 9/2006 Post cesarean delivery subjects recruited from 10/2005 to 5/2007

Subjects were excluded from the labor analgesia group if they had received an opioid analgesic before initiation of intrathecal analgesia or if they received neuraxial analgesia before 2cm of cervical dilation.

Participant milestones

Participant milestones
Measure	Labor Analgesia OPRM1 c304A Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304	Labor Analgesia OPRM1 c304A>G Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A\>G	Cesarean Delivery OPRM1 c304A Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A	Cesarean Delivery OPRM1 c304A>G Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A\>G
Overall Study STARTED	144	46	78	25
Overall Study COMPLETED	144	46	78	25
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mu-Opioid Receptor Genetic Polymorphism and Intrathecal Analgesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Labor Analgesia OPRM1 c304A n=144 Participants Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304	Labor Analgesia OPRM1 c304A>G n=46 Participants Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A\>G	Cesarean Delivery OPRM1 c304A n=78 Participants Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A	Cesarean Delivery OPRM1 c304A>G n=25 Participants Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A\>G	Total n=293 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	144 Participants n=5 Participants	46 Participants n=7 Participants	78 Participants n=5 Participants	25 Participants n=4 Participants	293 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	30 years n=5 Participants	32 years n=7 Participants	34 years n=5 Participants	32 years n=4 Participants	32 years n=21 Participants
Sex: Female, Male Female	144 Participants n=5 Participants	46 Participants n=7 Participants	78 Participants n=5 Participants	25 Participants n=4 Participants	293 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	144 participants n=5 Participants	46 participants n=7 Participants	78 participants n=5 Participants	25 participants n=4 Participants	293 participants n=21 Participants

PRIMARY outcome

Timeframe: Time (0-1440 minutes) to first analgesia request

Population: Laboring parturients that received intrathecal fentanyl (25 micrograms) for initiation of labor analgesia were evaluated for this outcome per protocol.

Time from intrathecal drug administration to request for analgesia either in laboring women of after cesarean delivery

Outcome measures

Outcome measures
Measure	Labor Analgesia OPRM1 c304A n=144 Participants Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304	Labor Analgesia OPRM1 c304A>G n=46 Participants Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A\>G	Cesarean Delivery OPRM1 c304A Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A	Cesarean Delivery OPRM1 c304A>G Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A\>G
Duration of Intrathecal Fentanyl Analgesia	70 Minutes Interval 62.0 to 78.0	63 Minutes Interval 50.0 to 76.0	—	—

PRIMARY outcome

Timeframe: 0 to 72 hours following cesarean delivery

Population: Subjects that received fentanyl and morphine for postpartum analgesia after planned cesarean delivery were analyzed per protocol.

Time until request for supplemental analgesia following intrathecal morphine/fentanyl for cesarean delivery

Outcome measures

Outcome measures
Measure	Labor Analgesia OPRM1 c304A Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304	Labor Analgesia OPRM1 c304A>G Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A\>G	Cesarean Delivery OPRM1 c304A n=78 Participants Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A	Cesarean Delivery OPRM1 c304A>G n=25 Participants Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A\>G
Duration of Intrathecal Analgesia Following Cesarean Delivery	—	—	26 Hours Interval 0.0 to 47.0	40 Hours Interval 0.0 to 60.0

PRIMARY outcome

Timeframe: VAS at analgesia request

Population: Analysis population per protocol.

Visual analog pain scale (0 to 100) at 1st request for supplemental analgesia

Outcome measures

Outcome measures
Measure	Labor Analgesia OPRM1 c304A n=144 Participants Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304	Labor Analgesia OPRM1 c304A>G n=46 Participants Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A\>G	Cesarean Delivery OPRM1 c304A n=78 Participants Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A	Cesarean Delivery OPRM1 c304A>G n=25 Participants Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A\>G
Visual Analog Pain Scale (0 to 100) at Analgesia Request Following Intrathecal Intervention	33 Units on a scale Interval 21.0 to 50.0	38 Units on a scale Interval 23.0 to 51.0	26 Units on a scale Interval 0.0 to 47.0	40 Units on a scale Interval 0.0 to 60.0

SECONDARY outcome

Timeframe: Labor analgesia

Severity of pruritus during labor analgesia

Outcome measures

Outcome measures
Measure	Labor Analgesia OPRM1 c304A n=144 Participants Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304	Labor Analgesia OPRM1 c304A>G n=46 Participants Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A\>G	Cesarean Delivery OPRM1 c304A Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A	Cesarean Delivery OPRM1 c304A>G Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A\>G
Severity of Pruritus Following Fentanyl None	9 participants	13 participants	—	—
Severity of Pruritus Following Fentanyl Mild	48 participants	59 participants	—	—
Severity of Pruritus Following Fentanyl Moderate	35 participants	26 participants	—	—
Severity of Pruritus Following Fentanyl Severe	8 participants	2 participants	—	—

SECONDARY outcome

Timeframe: 24 hours post cesarean delivery

Subjects reporting pruritus in the first 24 hours post cesarean delivery

Outcome measures

Outcome measures
Measure	Labor Analgesia OPRM1 c304A Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304	Labor Analgesia OPRM1 c304A>G Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A\>G	Cesarean Delivery OPRM1 c304A n=78 Participants Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A	Cesarean Delivery OPRM1 c304A>G n=25 Participants Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A\>G
Subjects With Pruritus at 24 Hours Post Morphine	—	—	33 participants	3 participants

Adverse Events

Labor Analgesia OPRM1 c304A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Labor Analgesia OPRM1 c304A>G

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cesarean Delivery OPRM1 c304A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cesarean Delivery OPRM1 c304A>G

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert J. McCarthy

Northwestern University Feinberg School of Medicine

Phone: 3129269015

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place