Post-operative Pain
Conditions
Brief summary
The purpose of this trial is to compare incisional pain in patients receiving pre-incisional versus post operative Marcaine injection.
Detailed description
Post-operative pain control is a key component of a patient's experience with surgery. In laparoscopic surgery, small (5 to 12mm) incisions are made, usually at the umbilicus and/on at either side of the lower abdomen, to allow insertion of a laparoscopic camera (scope) and various laparoscopic instruments. The advantages for the patient of this approach compared to conventional open surgery include faster recovery with a significantly shorter hospital stay, less pain and less requirements for pain medication with a better cosmetic outcome. In many cases, the patient will go home within 24 hours of surgery. Many laparoscopic surgeons administer local anesthesia at the incision sites to assist in post-operative pain control. The best method for administration of the local anesthetic for optimal pain relief remains unclear. Some research has demonstrated that perhaps preemptive administration of local anesthetic improves post-operative pain control although in these studies, differences in patient populations and perception of pain between different patients makes comparison difficult. Optimizing analgesia protocols would benefit patients resulting in better pain relief and less use of narcotic analgesics with their associated side effects.
Interventions
DRUGMarcaine- 0.25%
Marcaine 0.25% administered pre-incision.
DRUGMarcaine 0.25%.
Marcaine 0.25% administered post-incision.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Patients are acting as their own control receiving Bupivicaine (Marcaine) on both sides. One arm is pre incision the other arm is post incision.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* • Ages 18-50 * BMI 20-35 * Gynecologic ambulatory cases only * Total of 3 incisions, with left and right incisions both being 5mm-10mm in size * Not taking pain medications prior to surgery * Length of surgery up to 3 hours * PACU stay up to 6 hours * Willing and able to sign informed consent
Exclusion criteria
* • Age or BMI out of range * Surgery longer than 3 hours or PACU stay longer than 6 hours * patients with chronic pelvic pain * Oncologic cases * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wong-Baker Faces Pain Rating Scale | Post surgery day 0, post surgery day 1, post surgery day 2 | Pain level on post op day 1 and 2 study hypothesize will be less if Marcaine is administered pre instead of post incision. The pain scale is a numeric pain rating scale from 0-5, with zero being no pain and 5 being the worst pain imaginable, faces depicting no pain to worst pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medication Pre Incision Left Med Post Incision Right Participants acted as their own control with left side being injected with medication pre incision and right side being injected with medication post incision. | 10 |
| Medication Pre Incision Right Med Post Incision Left Participants acted as their own control with right side being injected with medication pre incision and left side being injected with medication post incision. | 17 |
| Total | 27 |
Baseline characteristics
| Characteristic | Medication Pre Incision Right Med Post Incision Left | Total | Medication Pre Incision Left Med Post Incision Right |
|---|---|---|---|
| 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 | 17 Participants | 27 Participants | 10 Participants |
| Age, Continuous | 30.92 years STANDARD_DEVIATION 3.87 | 32.26 years STANDARD_DEVIATION 4.83 | 33.6 years STANDARD_DEVIATION 5.79 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 17 participants | 27 participants | 10 participants |
| Sex: Female, Male Female | 17 Participants | 27 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
Wong-Baker Faces Pain Rating Scale
Pain level on post op day 1 and 2 study hypothesize will be less if Marcaine is administered pre instead of post incision. The pain scale is a numeric pain rating scale from 0-5, with zero being no pain and 5 being the worst pain imaginable, faces depicting no pain to worst pain.
Time frame: Post surgery day 0, post surgery day 1, post surgery day 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Marcaine Administered Pre-incision | Wong-Baker Faces Pain Rating Scale | Post Op day 0 | 1.675 units on a scale | Standard Deviation 1.39 |
| Marcaine Administered Pre-incision | Wong-Baker Faces Pain Rating Scale | Post Op day 1 | 2 units on a scale | Standard Deviation 0.97 |
| Marcaine Administered Pre-incision | Wong-Baker Faces Pain Rating Scale | Post Op day 2 | 1 units on a scale | Standard Deviation 1.6 |
| Marcaine Administered Post Incision | Wong-Baker Faces Pain Rating Scale | Post Op day 0 | 1.6 units on a scale | Standard Deviation 1.42 |
| Marcaine Administered Post Incision | Wong-Baker Faces Pain Rating Scale | Post Op day 1 | 1.85 units on a scale | Standard Deviation 1.45 |
| Marcaine Administered Post Incision | Wong-Baker Faces Pain Rating Scale | Post Op day 2 | 0.75 units on a scale | Standard Deviation 0.65 |
p-value: 0.8379t-test, 2 sided
p-value: 0.7263t-test, 2 sided
p-value: 0.5t-test, 2 sided