Trial Outcomes & Findings for Effect of Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia (NCT NCT00487084)

NCT ID: NCT00487084

Last Updated: 2014-04-14

Results Overview

Time to first request for supplemental analgesia

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 136 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2014-04-14

Participant Flow

136 subjects approached and assessed for eligibility

Excluded from randomization (n=37), 26 refused to participate, 11 did not meet exclusion criteria

Participant milestones

Measure	Morphine - 2 Chloroprocaine - Saline (MCS) morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision	Saline-2 Chloroprocaine - Morphine (SCM) saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision	Saline - Lidocaine - Morphine (SLM) Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
Overall Study STARTED	33	33	33
Overall Study COMPLETED	29	30	28
Overall Study NOT COMPLETED	4	3	5

Reasons for withdrawal

Measure	Morphine - 2 Chloroprocaine - Saline (MCS) morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision	Saline-2 Chloroprocaine - Morphine (SCM) saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision	Saline - Lidocaine - Morphine (SLM) Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
Overall Study Did not receive intervention	4	3	5

Baseline Characteristics

Effect of Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia

Baseline characteristics by cohort

Measure	Morphine - 2 Chloroprocaine - Saline (MCS) n=33 Participants morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision	Saline-2 Chloroprocaine - Morphine (SCM) n=33 Participants saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision	Saline - Lidocaine - Morphine (SLM) n=33 Participants Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.	Total n=99 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
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	33 Participants n=7 Participants	33 Participants n=5 Participants	99 Participants n=4 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
Age, Continuous	33 years STANDARD_DEVIATION 4 • n=5 Participants	31 years STANDARD_DEVIATION 5 • n=7 Participants	29 years STANDARD_DEVIATION 4 • n=5 Participants	30 years STANDARD_DEVIATION 4 • n=4 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	33 Participants n=7 Participants	33 Participants n=5 Participants	99 Participants n=4 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
Region of Enrollment United States	33 participants n=5 Participants	33 participants n=7 Participants	33 participants n=5 Participants	99 participants n=4 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: All participants receiving the intervention were analyzed

Time to first request for supplemental analgesia

Outcome measures

Measure	Morphine - 2 Chloroprocaine - Saline (MCS) n=29 Participants morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision	Saline-2 Chloroprocaine - Morphine (SCM) n=30 Participants saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision	Saline - Lidocaine - Morphine (SLM) n=28 Participants Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
Duration of Continuing Analgesia	28.6 hours Interval 4.4 to 52.7	2.2 hours Interval 0.0 to 4.8	25.8 hours Interval 10.7 to 40.9

PRIMARY outcome

Timeframe: 90 min

Participants requesting supplemental analgesia in the first 90 minutes following study drug

Outcome measures

Measure	Morphine - 2 Chloroprocaine - Saline (MCS) n=29 Participants morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision	Saline-2 Chloroprocaine - Morphine (SCM) n=30 Participants saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision	Saline - Lidocaine - Morphine (SLM) n=28 Participants Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
Supplemental Analgesia in First 90 Minutes	0 participants	10 participants	0 participants

SECONDARY outcome

Timeframe: At recovery room entry

Population: Verbal Rating Score for Pain (0-10) where 0 = no pain and 10 = worst pain imaginable

Verbal Rating Pain Score (VRPS) at time of post-anesthesia recovery room entry, where 0 = no pain and 10 = worst pain imaginable

Outcome measures

Measure	Morphine - 2 Chloroprocaine - Saline (MCS) n=29 Participants morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision	Saline-2 Chloroprocaine - Morphine (SCM) n=30 Participants saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision	Saline - Lidocaine - Morphine (SLM) n=28 Participants Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
Verbal Rating Score (0 to 10) for Pain (VRPS)	2 Scores on a scale Interval 0.0 to 4.5	2 Scores on a scale Interval 1.8 to 4.0	0 Scores on a scale Interval 0.0 to 1.5

SECONDARY outcome

Timeframe: 48 hours

Participants requesting supplemental analgesia in first 48 hours

Outcome measures

Measure	Morphine - 2 Chloroprocaine - Saline (MCS) n=29 Participants morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision	Saline-2 Chloroprocaine - Morphine (SCM) n=30 Participants saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision	Saline - Lidocaine - Morphine (SLM) n=28 Participants Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
Supplemental Analgesia in First 48 Hours	12 Participants	8 Participants	12 Participants

Adverse Events

Morphine - 2 Chloroprocaine - Saline (MCS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline-2 Chloroprocaine - Morphine (SCM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline - Lidocaine - Morphine (SLM)

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

Cynthia A. Wong,M.D.

Northwestern University

Phone: 630-472-3555

Email: c-wong2@northwestern.edu

Results disclosure agreements

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