NCT03247257

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

3.8 years

First QC Date

July 26, 2017

Last Update Submit

August 8, 2017

Conditions

Cholelithiasis

Outcome Measures

Primary Outcomes (1)

  • Post Anesthesia Recovery Score for Ambulatory Patients

    PARSAP scores in the post-anesthesia recovery unit

    Immediately postoperative

Secondary Outcomes (3)

  • SF-12 Health survey scores

    Postoperative days 1, 6, 7/8/9 or 10, 30, 90

  • Pain

    Immediately postoperative through postoperative day 90

  • Opioid requirement

    Preoperative through postoperative day 90

Study Arms (2)

Group A: General Anesthesia

ACTIVE COMPARATOR

35 patients will be randomized to receive general anesthesia during their laparoendoscopic single site incision cholecystectomy.

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.

Procedure: Epidural Anesthesia

Interventions

General AnesthesiaPROCEDURE

Patients will be put under general anesthesia for cholecystectomy

Also known as: IV propofol
Group A: General Anesthesia
Epidural AnesthesiaPROCEDURE

Patients will receive Epidural Anesthesia for cholecystectomy

Also known as: Epidural lidocaine
Group B: Epidural Anesthesia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Hospital Tampa

Tampa, Florida, 33613, United States

Location

MeSH Terms

Conditions

Cholelithiasis

Interventions

Anesthesia, GeneralPropofolAnesthesia, Epidural

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnesthesia, Conduction

Study Officials

  • Sharona Ross, MD

    Florida Hospital Tampa

    PRINCIPAL INVESTIGATOR

  • Alexander Rosemurgy, MD

    Florida Hospital Tampa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Surgical Digestive Disorders and GERD Center

Study Record Dates

First Submitted

July 26, 2017

First Posted

August 11, 2017

Study Start

February 1, 2015

Primary Completion

December 1, 2018

Study Completion

April 1, 2019

Last Updated

August 11, 2017

Record last verified: 2017-08

Locations

US(1)