Laparoscopic CholecystectomyNCT01823224
Comparing Effectiveness of IV vs Oral Acetaminophen Given Perioperatively for Lap Choles for Pain Control,
A study testing 2 capsules Oral Tylenol 2000 mg and IV "salt water" and IV tylenol 1000mg and 2 oral capsule "sugar pills" in people with Laparoscopic Cholecystectomy, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- 2 capsules Oral Tylenol 2000 mg and IV "salt water" and IV tylenol 1000mg and 2 oral capsule "sugar pills"
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Womack Army Medical Center
Fort Bragg, North Carolina, 28310
About this study
Official title: A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy
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.
Read the 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)
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- 2 capsules Oral Tylenol 2000 mg and IV "salt water", IV tylenol 1000mg and 2 oral capsule "sugar pills"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 capsules Oral Tylenol 2000 mg and IV "salt water"Drug
Also called Acetaminophen is comercially referred to as Tylenol.
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.
IV tylenol 1000mg and 2 oral capsule "sugar pills"Drug
Also called Acetaminophen is comercially referred to as Tylenol.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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 Receives: Drug: IV tylenol 1000mg and 2 oral capsule "sugar pills" |
| Group 2 | Experimental | 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. Receives: Drug: 2 capsules Oral Tylenol 2000 mg and IV "salt water" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after discharge
Secondary outcomes (1)
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
Measured: every 6 hours for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Defense and Veterans Center for Integrative Pain Management
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony R Plunkett, MD, Principal investigator, Womack Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823224
- Sponsor's protocol ID
- 380250
- Status last verified
- May 2016
- First submitted
- 29 Mar 2013
- Last updated
- 6 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01823224
- Acronym / sponsor ID
- 380250
- Conditions
- Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Defense and Veterans Center for Integrative Pain ManagementUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 6 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: IV tylenol 1000mg and 2 oral capsule "sugar pills"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 |
| Group 2 | Experimental | Drug: 2 capsules Oral Tylenol 2000 mg and IV "salt water"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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 capsules Oral Tylenol 2000 mg and IV "salt water"Also: Acetaminophen is comercially referred to as Tylenol.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. | Drug | Group 2 |
| IV tylenol 1000mg and 2 oral capsule "sugar pills"Also: Acetaminophen is comercially referred to as Tylenol.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. | Drug | Group 1 |
Primary outcome
Pain
Time frame: 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.
1 secondary outcome
Total Opioid Consumption From Time of First Waking to T24
Time frame: every 6 hours for 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony R Plunkett, MD principal investigator
Womack Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 capsules Oral Tylenol 2000 mg and IV "salt water" and IV tylenol 1000mg and 2 oral capsule "sugar pills" in people with Laparoscopic Cholecystectomy, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 24 hours after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2016.