Postoperative Pain
Conditions
Brief summary
prospective, randomized double blinded study to investigate the effects of morphine as an adjuvant to ropivacaine on FICB
Interventions
DRUGRopivacaine, Morphine
Morphine added to ropivacaine for fascia iliaca compartment block
DRUGRopivacaine, Saline
Normal saline added to ropivacaine for fascia iliaca compartment block
Sponsors
B.P. Koirala Institute of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* All patients undergoing elective femur surgery under spinal anaesthesia * Age group (18-65 years) * ASA physical status I and II
Exclusion criteria
* • Not willing to participate in the study * Other painful co-morbidities (neuropathies) * Allergy or any contraindication to study medication * Psychiatric disorder * Coagulopathy * Infection at the site of the block * Use of other modes of anaesthesia or analgesia besides spinal anaesthesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Analgesia | 24 hours | The period in minutes when the patient is free of pain |
Countries
Nepal
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 35 |
| 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 | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Ropivacaine Group | Ropivacaine and Morphine Group | 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 | 35 Participants | 35 Participants | 70 Participants |
| Age, Continuous | 47 years STANDARD_DEVIATION 15 | 43 years STANDARD_DEVIATION 12 | 45 years STANDARD_DEVIATION 13 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Nepal | 35 Participants | 35 Participants | 70 Participants |
| Sex: Female, Male Female | 15 Participants | 10 Participants | 25 Participants |
| Sex: Female, Male Male | 20 Participants | 25 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
Duration of Analgesia
The period in minutes when the patient is free of pain
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine Group | Duration of Analgesia | 541 minutes | Standard Deviation 167 |
| Ropivacaine and Morphine Group | Duration of Analgesia | 634 minutes | Standard Deviation 164 |