Post Operative Pain (Post Laparoscopic Hernia Repair)
Conditions
Keywords
Post Operative Pain, hernia repair
Brief summary
To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia repair on post-operative pain.
Interventions
DRUG0.5% Bupivicaine
Local anesthetic
Sponsors
Lahey Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 or older with unilateral or bilateral inguinal herna for laparoscopic repair * American Society of Anesthesiology (ASA) Class I and II
Exclusion criteria
* Conversion from laparoscopic to open surgery * History of Chronic pain or ongoing treatment for chronic pain * Age less than 18 yrs * Allergy to local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale Pain Score Assessment (VAS) | Post-operative period | Pain level at 4 hours after surgery VAS scale measures pain in whole numbers from 0 (no pain) to 10 (worst imaginable pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Pain Medication Used in Oral Morphine Equivalents | 4 hours after surgery | Total mg of opiate after surgery |
| Duration of Narcotic Used to Control Pain | 4 weeks post-op | Number of days post-operatively narcotic is used |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anesthetic Intervention After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine.
0.5% Bupivicaine: Local anesthetic | 35 |
| Saline Intervention After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline.
0.5% Bupivicaine: Local anesthetic | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Anesthetic Intervention | Saline Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 35 Participants | 35 Participants | 70 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 35 participants | 35 participants | 70 participants |
| Sex: Female, Male Female | 33 Participants | 34 Participants | 67 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 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
Visual Analog Scale Pain Score Assessment (VAS)
Pain level at 4 hours after surgery VAS scale measures pain in whole numbers from 0 (no pain) to 10 (worst imaginable pain)
Time frame: Post-operative period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anesthetic Intervention | Visual Analog Scale Pain Score Assessment (VAS) | 2.96 score on a scale | Standard Deviation 2.3 |
| Saline Intervention | Visual Analog Scale Pain Score Assessment (VAS) | 3.24 score on a scale | Standard Deviation 1.57 |
Primary
Visual Analog Scale Pain Score Assessment (VAS)
Pain level recorded at 3 days after surgery. VAS scale measures pain in increments of whole numbers from 0 (no pain) to 10 (most sever pain imaginable)
Time frame: Pain scale 3 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anesthetic Intervention | Visual Analog Scale Pain Score Assessment (VAS) | 3.71 units on a scale | Standard Deviation 2.08 |
| Saline Intervention | Visual Analog Scale Pain Score Assessment (VAS) | 3.25 units on a scale | Standard Deviation 1.66 |
Secondary
Amount of Pain Medication Used in Oral Morphine Equivalents
Total mg of opiate after surgery
Time frame: 4 hours after surgery
Population: one patient's data is missing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anesthetic Intervention | Amount of Pain Medication Used in Oral Morphine Equivalents | 8.37 oral morphine equivalents | Standard Deviation 12.18 |
| Saline Intervention | Amount of Pain Medication Used in Oral Morphine Equivalents | 7.72 oral morphine equivalents | Standard Deviation 10.23 |
Secondary
Duration of Narcotic Used to Control Pain
Number of days post-operatively narcotic is used
Time frame: 4 weeks post-op
Population: Data were not collected for any patients.