CholelithiasisNCT03247257
Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies
A study testing General Anesthesia and Epidural Anesthesia in people with Cholelithiasis, run by Florida Hospital Tampa Bay Division at 1 site in United States.
Trial summary
This study is a prospective, comparative, controlled, blinded study that will enroll a total of 70 adults that will undergo elective laparoendoscopic single-site incision gallbladder removal. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- General Anesthesia and Epidural Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65 years of age
- ASA I or II
- Patient has a diagnosis of biliary colic with documented cholecystitis, symptomatic gallstones, polyps by imaging or biliary dyskinesia with documented EF < 30%
- No cardiopulmonary disease
- Normal coagulation profile
Who cannot join
- Any female patient, who is pregnant, suspected pregnant, or nursing
- Contraindication for pneumoperitoneum
- Contraindication for epidural anesthesia
- Allergy to local anesthetic agents
- Any patient with acute calculus or acalculous cholecystitis
- Any patient who has had an upper midline or right sub costal incision
Show all 14Show fewer
- Any patient with preoperative indication for a cholangiogram
- Any patient with ASA ≥ 3
- Any patient who is undergoing Peritoneal Dialysis (PD)
- History of long term analgesic use requiring pain management (>1 week)
- Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair
- Any patient with obstructive sleep apnea (OSA), history of OSA or at high risk of OSA as determined by the STOP Questionnaire
- BMI > 35 kg/m2
- Any patient with a history of severe, uncontrolled GERD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidural Versus General Anesthesia for Laparoendoscopic Single Site Cholecystectomy: A Prospective, Comparative, Controlled, Blinded Study
This study is a prospective, comparative, controlled, blinded study that will enroll a total of 70 adults that will undergo elective laparoendoscopic single-site incision gallbladder removal. The objective of this study is to compare Epidural versus General Anesthesia for postoperative pain, length of hospital stay, outcomes, and cost of post-cholecystectomy patients.
Read the detailed description
This is a prospective, comparative, controlled, blinded study that will enroll a total of 70 adult patients that require an elective cholecystectomy.
Patients will be randomized 1:1 to receive either general anesthesia (Group A) or epidural anesthesia (Group B) for their laparoendoscopic single site incision (LESS) gallbladder removal surgery (cholecystectomy). Randomization will be achieved using a computer-generated list. The patient will know what are they are randomized to before entering the operating room because an epidural will need to be placed preoperatively. Standards for basic anesthetic monitoring approved by the American Society of Anesthesiologists will occur intraoperatively.
Postoperative evaluations will be completed by a medical professional that is blinded to the type of anesthesia used during the LESS surgery. Postoperative evaluations include a physical exam, adverse events, medication administration, vital signs and post-anesthesia recovery score for ambulatory patients (PARSAP) scores will be taken every 15 minutes until the patient has a score of at least 18.
Patients will be followed 90 days postoperatively to collect pain scores, analgesic use, adverse events, and quality of life questionnaires.
- Conditions
- Cholelithiasis
- Being tested
- General Anesthesia, Epidural Anesthesia
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AnesthesiaProcedure or surgery
Also called IV propofol
Patients will be put under general anesthesia for cholecystectomy
Epidural AnesthesiaProcedure or surgery
Also called Epidural lidocaine
Patients will receive Epidural Anesthesia for cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Group A: General Anesthesia | Active comparator | 35 patients will be randomized to receive general anesthesia during their laparoendoscopic single site incision cholecystectomy. Receives: Procedure: General Anesthesia |
| Group B: Epidural Anesthesia | Active comparator | 35 patients will be randomized to receive epidural anesthesia during their laparoendoscopic single site incision cholecystectomy. Receives: Procedure: Epidural Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Anesthesia Recovery Score for Ambulatory Patients
PARSAP scores in the post-anesthesia recovery unit
Measured: Immediately postoperative
Secondary outcomes (3)
SF-12 Health survey scores
scale of 12-47
Measured: Postoperative days 1, 6, 7/8/9 or 10, 30, 90
Pain
VAS 0-10 scale
Measured: Immediately postoperative through postoperative day 90
Opioid requirement
Opioid use in milligrams through postoperative day 90 will be recorded.
Measured: Preoperative through postoperative day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study startFeb 2015
- Primary completionDec 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Hospital Tampa Bay Division
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Rosemurgy, Florida Hospital Tampa Bay Division
- Investigators
- Sharona Ross, MD, Principal investigator, Florida Hospital TampaAlexander Rosemurgy, MD, Principal investigator, Florida Hospital Tampa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247257
- Sponsor's protocol ID
- 482717 revised
- Status last verified
- Aug 2017
- First submitted
- 26 Jul 2017
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Versus General Anesthesia for Laparoendoscopic Single Site Cholecystectomy: A Prospective, Comparative, Controlled, Blinded Study
- ClinicalTrials.gov ID
- NCT03247257
- Acronym / sponsor ID
- 482717 revised
- Conditions
- Cholelithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Florida Hospital Tampa Bay DivisionUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, comparative, controlled, blinded study that will enroll a total of 70 adults that will undergo elective laparoendoscopic single-site incision gallbladder removal. The objective of this study is to compare Epidural versus General Anesthesia for postoperative pain, length of hospital stay, outcomes, and cost of post-cholecystectomy patients.
Detailed description
This is a prospective, comparative, controlled, blinded study that will enroll a total of 70 adult patients that require an elective cholecystectomy.
Patients will be randomized 1:1 to receive either general anesthesia (Group A) or epidural anesthesia (Group B) for their laparoendoscopic single site incision (LESS) gallbladder removal surgery (cholecystectomy). Randomization will be achieved using a computer-generated list. The patient will know what are they are randomized to before entering the operating room because an epidural will need to be placed preoperatively. Standards for basic anesthetic monitoring approved by the American Society of Anesthesiologists will occur intraoperatively.
Postoperative evaluations will be completed by a medical professional that is blinded to the type of anesthesia used during the LESS surgery. Postoperative evaluations include a physical exam, adverse events, medication administration, vital signs and post-anesthesia recovery score for ambulatory patients (PARSAP) scores will be taken every 15 minutes until the patient has a score of at least 18.
Patients will be followed 90 days postoperatively to collect pain scores, analgesic use, adverse events, and quality of life questionnaires.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: General Anesthesia | Active comparator | Procedure: General Anesthesia35 patients will be randomized to receive general anesthesia during their laparoendoscopic single site incision cholecystectomy. |
| Group B: Epidural Anesthesia | Active comparator | Procedure: Epidural Anesthesia35 patients will be randomized to receive epidural anesthesia during their laparoendoscopic single site incision cholecystectomy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged between 18 and 65 years of age
- ASA I or II
- Patient has a diagnosis of biliary colic with documented cholecystitis, symptomatic gallstones, polyps by imaging or biliary dyskinesia with documented EF < 30%
- No cardiopulmonary disease
- Normal coagulation profile
Key exclusion criteria (14 listed)
- Any female patient, who is pregnant, suspected pregnant, or nursing
- Contraindication for pneumoperitoneum
- Contraindication for epidural anesthesia
- Allergy to local anesthetic agents
- Any patient with acute calculus or acalculous cholecystitis
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 |
|---|---|---|
| General AnesthesiaAlso: IV propofolPatients will be put under general anesthesia for cholecystectomy | Procedure or surgery | Group A: General Anesthesia |
| Epidural AnesthesiaAlso: Epidural lidocainePatients will receive Epidural Anesthesia for cholecystectomy | Procedure or surgery | Group B: Epidural Anesthesia |
Primary outcome
Post Anesthesia Recovery Score for Ambulatory Patients
Time frame: Immediately postoperative
PARSAP scores in the post-anesthesia recovery unit
3 secondary outcomes
SF-12 Health survey scores
Time frame: Postoperative days 1, 6, 7/8/9 or 10, 30, 90
Pain
Time frame: Immediately postoperative through postoperative day 90
Opioid requirement
Time frame: Preoperative through postoperative day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Cholelithiasis
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
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Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
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Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis
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.
Sharona Ross, MD principal investigator
Florida Hospital Tampa
Alexander Rosemurgy, MD principal investigator
Florida Hospital Tampa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Anesthesia and Epidural Anesthesia in people with Cholelithiasis, run by Florida Hospital Tampa Bay Division 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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 11 Aug 2017. 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?
Results are not available in the source record.
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?
Post Anesthesia Recovery Score for Ambulatory Patients (time frame: Immediately postoperative). 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 11 Aug 2017.