Trial Outcomes & Findings for Morphine Added to Ropivacaine for FICB for Postoperative Analgesia (NCT NCT03875274)

NCT ID: NCT03875274

Last Updated: 2023-03-24

Results Overview

The period in minutes when the patient is free of pain

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2023-03-24

Participant Flow

Participant milestones

Measure	Ropivacaine Group Ropivacaine 0.375% 20 ml + Normal saline 2 ml via FICB Ropivacaine, Saline: Normal saline added to ropivacaine for fascia iliaca compartment block	Ropivacaine and Morphine Group Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB Ropivacaine, Morphine: Morphine added to ropivacaine for fascia iliaca compartment block
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ropivacaine Group n=35 Participants Ropivacaine 0.375% 20 ml + Normal saline 2 ml via FICB Ropivacaine, Saline: Normal saline added to ropivacaine for fascia iliaca compartment block	Ropivacaine and Morphine Group n=35 Participants Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB Ropivacaine, Morphine: Morphine added to ropivacaine for fascia iliaca compartment block	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=35 Participants	0 Participants n=35 Participants	0 Participants n=70 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=35 Participants	35 Participants n=35 Participants	70 Participants n=70 Participants
Age, Categorical >=65 years	0 Participants n=35 Participants	0 Participants n=35 Participants	0 Participants n=70 Participants
Age, Continuous	47 years STANDARD_DEVIATION 15 • n=35 Participants	43 years STANDARD_DEVIATION 12 • n=35 Participants	45 years STANDARD_DEVIATION 13 • n=70 Participants
Sex: Female, Male Female	15 Participants n=35 Participants	10 Participants n=35 Participants	25 Participants n=70 Participants
Sex: Female, Male Male	20 Participants n=35 Participants	25 Participants n=35 Participants	45 Participants n=70 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Nepal	35 Participants n=35 Participants	35 Participants n=35 Participants	70 Participants n=70 Participants

PRIMARY outcome

Timeframe: 24 hours

The period in minutes when the patient is free of pain

Outcome measures

Measure	Ropivacaine Group n=35 Participants Ropivacaine 0.375% 20 ml + Normal saline 2 ml via FICB Ropivacaine, Saline: Normal saline added to ropivacaine for fascia iliaca compartment block	Ropivacaine and Morphine Group n=35 Participants Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB Ropivacaine, Morphine: Morphine added to ropivacaine for fascia iliaca compartment block
Duration of Analgesia	541 minutes Standard Deviation 167	634 minutes Standard Deviation 164

Adverse Events

Ropivacaine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ropivacaine and Morphine Group

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. Pankaj Baral

BPKIHS

Phone: 9856037077

Email: pankajbaral7@gmail.com

Results disclosure agreements

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