Laparoscopic Cholecystectomy
Conditions
Brief summary
The purpose of the study is to learn whether perioperative IV (intravenous) administration of acetaminophen (commonly referred to as Tylenol) shows any different clinical outcomes over the oral (by mouth) administration of acetaminophen for a patient having a laparoscopic cholecystectomy. If improved pain scores occur with the administration of IV acetaminophen, it may result in fewer requests for pain-related intervention such as other oral pain medications.
Detailed description
Subjects were enrolled following the listed inclusion and exclusion criteria. Subjects Eligibility Criteria: Inclusion Criteria: Male and female patients ASA I - III . 18 years of age and older Exclusion Criteria: Chronic pain syndromes (pain symptoms lasting greater than 3 months), previous abdominal surgery Chronic home narcotic use (patient-reported narcotic use for greater than 3 months) Previous Bowel resection, colon surgery, stomach surgery . Liver disease (AST or ALT greater than 3 times upper limit of normal), on labs closest to surgical date or within 6 months prior to surgery Severe renal disease (creatinine clearance less than 30 mL/min), on labs closest to surgical date or within 6 months prior to surgery Open or emergency surgery (non-scheduled surgery, surgery that must be performed within 6 hours for this particular surgery) Prior NSAIDS (Non-Steroid Anti-inflammatory Drugs) including COX-2 agents use within the last 24 hours Use of intraoperative NSAIDs Contraindication to study drug (including allergic reaction or hypersensitivity to acetaminophen or any of its components; Taking a medication with known interactions with acetaminophen Taking chronic oral acetaminophen, greater than 6 months on a daily basis at a dose greater than 3000mg/day Pregnancy Current or past alcohol abuse (within the past 2 years)
Interventions
DRUG2 capsules Oral Tylenol 2000 mg and IV salt water
The participants randomized to receive the '2 capsules Oral Acetaminophen 500 mg and IV salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly.
DRUGIV tylenol 1000mg and 2 oral capsule sugar pills
IV acetaminophen 1000mg and 2 oral capsule sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group.
Sponsors
Defense and Veterans Center for Integrative Pain Management
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients ASA I - III (A system used by anesthesiologists to stratify severity of patients' underlying disease and potential for suffering complications from general anesthesia ), 18 years of age and older * Patient must be scheduled for laparoscopic cholecystectomy
Exclusion criteria
* Chronic pain syndromes (pain symptoms lasting greater than 3 months), previous abdominal surgery * Chronic home narcotic use (patient-reported narcotic use for greater than 3 months) * Liver disease (AST or ALT greater than 3 times upper limit of normal), on labs closest to surgical date or within 6 months prior to surgery * Severe renal disease (creatinine clearance less than 30 mL/min), on labs closest to surgical date or within 6 months prior to surgery * Open or emergency surgery (non-scheduled surgery, surgery that must be performed within 6 hours for this particular surgery) * Prior NSAIDS(Non-Steroid Anti-inflammatory Drugs) including COX-2 agents use within the last 24 hours * Use of intraoperative NSAIDs * Contraindication to study drug (including allergic reaction or hypersensitivity to acetaminophen or any of its components; * On a medication with known interactions with acetaminophen * On chronic oral acetaminophen, greater than 6 months on a daily basis at a dose greater than 3000mg/day * Pregnancy * Current or past alcohol abuse (within the past 2 years)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 24 hours after discharge | Pain after treatment with IV versus oral tylenol will be assessed via pain scores utilizing an numerical rating scale (NRS) )0-10 with 0 as no pain and 10 as worst pain with 5 as moderate pain and faces accompanied the scores with full smile on no pain to tears and frown on worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption From Time of First Waking to T24 | every 6 hours for 24 hours | Pain diary will be filled out every 6 hours for 24 hours after discharge in which the following will be recorded: * Opioid consumption from first waking to T4 * Total opioid consumption from T0 to T4 * Total opioid consumption from time of first waking to T24 |
Countries
United States
Participant flow
Recruitment details
Adult patients (male and non-pregnant females, 18 years of age or older) with symptomatic cholelithiasis and ASA rating of I-III scheduled to undergo elective LapChole were eligible for this trial.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules sugar pills 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg
IV tylenol 1000mg and 2 oral capsule sugar pills: IV acetaminophen 1000mg and 2 oral capsule sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group. | 28 |
| Group 2 Group 2 will receive an IV salt water infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.
2 capsules Oral Tylenol 2000 mg and IV salt water: The participants randomized to receive the '2 capsules Oral Acetaminophenl 500 mg and IV salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly. | 22 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | didn't qualify | 1 | 2 |
| Overall Study | Lost to Follow-up | 5 | 6 |
| Overall Study | missed med dose | 0 | 1 |
| Overall Study | pharmacy error | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Group 2 | Total | Group 1 |
|---|---|---|---|
| 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 | 22 Participants | 50 Participants | 28 Participants |
| Age, Continuous | 37.00 years STANDARD_DEVIATION 10.65 | 40.32 years STANDARD_DEVIATION 11.39 | 43.64 years STANDARD_DEVIATION 12.13 |
| 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 | 2 Participants | 8 Participants | 6 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 | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 37 Participants | 21 Participants |
| Region of Enrollment United States | 22 participants | 50 participants | 28 participants |
| Sex: Female, Male Female | 21 Participants | 42 Participants | 21 Participants |
| Sex: Female, Male Male | 1 Participants | 8 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 28 | 0 / 22 |
| serious Total, serious adverse events | 1 / 28 | 0 / 22 |
Outcome results
Primary
Pain
Pain after treatment with IV versus oral tylenol will be assessed via pain scores utilizing an numerical rating scale (NRS) )0-10 with 0 as no pain and 10 as worst pain with 5 as moderate pain and faces accompanied the scores with full smile on no pain to tears and frown on worst pain.
Time frame: 24 hours after discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Pain | Arrival in PACU | 1.61 NRS scale | Standard Deviation 2.78 |
| Group 1 | Pain | Discharge from PACU | 2.36 NRS scale | Standard Deviation 1.73 |
| Group 1 | Pain | Discharge+6hrs | 4.81 NRS scale | Standard Deviation 2.24 |
| Group 1 | Pain | Discharge+12hrs | 5.09 NRS scale | Standard Deviation 2.6 |
| Group 1 | Pain | pre-op | 1.41 NRS scale | Standard Deviation 2.09 |
| Group 1 | Pain | Discharge+18hrs | 4.12 NRS scale | Standard Deviation 2.62 |
| Group 1 | Pain | Discharge+24hrs | 3.96 NRS scale | Standard Deviation 2.47 |
| Group 2 | Pain | Discharge+18hrs | 4.21 NRS scale | Standard Deviation 2.07 |
| Group 2 | Pain | Arrival in PACU | 2.32 NRS scale | Standard Deviation 2.73 |
| Group 2 | Pain | pre-op | 1.73 NRS scale | Standard Deviation 1.93 |
| Group 2 | Pain | Discharge from PACU | 2.64 NRS scale | Standard Deviation 1.56 |
| Group 2 | Pain | Discharge+12hrs | 4.71 NRS scale | Standard Deviation 2.08 |
| Group 2 | Pain | Discharge+6hrs | 4.81 NRS scale | Standard Deviation 1.69 |
| Group 2 | Pain | Discharge+24hrs | 4.09 NRS scale | Standard Deviation 1.77 |
p-value: 0.875Repeated analysis of variance
Secondary
Total Opioid Consumption From Time of First Waking to T24
Pain diary will be filled out every 6 hours for 24 hours after discharge in which the following will be recorded: * Opioid consumption from first waking to T4 * Total opioid consumption from T0 to T4 * Total opioid consumption from time of first waking to T24
Time frame: every 6 hours for 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Total Opioid Consumption From Time of First Waking to T24 | PACU | 13.46 milligrams | Standard Deviation 23.2 |
| Group 1 | Total Opioid Consumption From Time of First Waking to T24 | Home Consumption | 36.96 milligrams | Standard Deviation 33.19 |
| Group 1 | Total Opioid Consumption From Time of First Waking to T24 | Total consumption from peration to 24 hrs | 153.38 milligrams | Standard Deviation 57.32 |
| Group 2 | Total Opioid Consumption From Time of First Waking to T24 | PACU | 17.41 milligrams | Standard Deviation 17.91 |
| Group 2 | Total Opioid Consumption From Time of First Waking to T24 | Home Consumption | 39.56 milligrams | Standard Deviation 37.56 |
| Group 2 | Total Opioid Consumption From Time of First Waking to T24 | Total consumption from peration to 24 hrs | 163.86 milligrams | Standard Deviation 78.04 |
p-value: >0.05Manova