Spinal AnesthesiaSALCNCT00492453
Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy
A study testing laparoscopic cholecystectomy in people with Spinal Anesthesia and General Anesthesia, run by University of Thessaly at 1 site in Greece.
Trial summary
The purpose of the study is to assess whether spinal anesthesia is or not superior to the standard general anesthesia for fit patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia, General Anesthesia, Postoperative Pain
- What is being tested?
- laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2004to Sep 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective laparoscopic cholecystectomy
- ASA I, II
- BMI< 30
- normal coagulation profile
Who cannot join
- acute cholecystitis / cholangitis / pancreatitis
- previous open surgery in the upper abdomen
- contraindication for pneumoperitoneum
- contraindication for spinal anesthesia (ie spinal deformity)
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Larissa
Larissa, Thessaly, 411 10
George Tzovaras, MD, +30 2410 682730, gtzovaras@hotmail.com
Frank Fafoulakis, MD
About this study
Official title: A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Elective Laparoscopic Cholecystectomy in Fit Patients
The purpose of the study is to assess whether spinal anesthesia is or not superior to the standard general anesthesia for fit patients undergoing laparoscopic cholecystectomy.
Read the detailed description
Laparoscopic cholecystectomy under regional anesthesia alone has been reported only occasionally in the past; all these reports included patients unfit to receive general anesthesia, mainly patients with severe chronic obstructive airway disease. Regional anesthesia has been used for laparoscopy in fit patients almost exclusively in combination with general anesthesia, in order to extend the analgesic effect during the early postoperative period. Surprisingly, in the era of minimally invasive medicine, regional anesthesia has not gained popularity, and has not been routinely used as a sole method of anesthesia in laparoscopic procedures. It is generally accepted that all laparoscopic procedures are merely a change in access and still require general anesthetic; hence the difference from conventional surgery is likely to be small. This statement is predominantly based on the assumption that laparoscopy necessitates endotracheal intubation to prevent aspiration and respiratory embarrassment secondary to the induction of CO2 pneumoperitoneum which in turn is not well tolerated in a patient who is awake during the procedure. However, it is surprising that regional anesthesia has been successfully used for laparoscopic cholecystectomy in patients unfit to have the procedure under general anesthesia, but has not been tested in fit patients, in whom any presumed risk would be, theoretically, much lower. We have recently shown in a pilot study the feasibility to perform successfully and safely laparoscopic cholecystectomy with low pressure CO2 pneumoperitoneum under spinal anesthesia alone, in fit patients with symptomatic gallstone disease. We have also noticed that spinal anesthesia results in exceptionally minimal postoperative pain. After this pilot study, we designed a controlled randomized trial in order to compare spinal anesthesia with the standard general anesthesia for elective laparoscopic cholecystectomy in fit patients.
- Conditions
- Spinal Anesthesia, General Anesthesia, Postoperative Pain
- Being tested
- laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic cholecystectomyProcedure or surgery
elective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Laparoscopic cholecystectomy under spinal anesthesia Receives: Procedure: laparoscopic cholecystectomy |
| 2 | Active comparator | Laparoscopic cholecystectomy under general anesthesia Receives: Procedure: laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Measured: 24hrs
Secondary outcomes (3)
complications
Measured: 30 days
hospital stay
Measured: time from intervention to discharge
patient satisfaction
Measured: within 2 weeks from intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startSep 2004
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Collaborators
- Larissa University Hospital
- Investigators
- Constantine Hatzitheofilou, MD, Study chair, University of Thessaly, School of MedicineGeorge Tzovaras, MD, Study director, University of Thessaly, School of MedicineFrank Fafoulakis, MD, Principal investigator, University Hospital of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492453
- Sponsor's protocol ID
- UThessaly 9-04
- Acronym
- SALC
- Status last verified
- Jun 2008
- First submitted
- 26 Jun 2007
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tzovaras G, Fafoulakis F, Pratsas K, Georgopoulou S, Stamatiou G, Hatzitheofilou C. Laparoscopic cholecystectomy under spinal anesthesia: a pilot study. Surg Endosc. 2006 Apr;20(4):580-2. doi: 10.1007/s00464-005-0405-1. Epub 2006 Jan 25.
PubMed 16437265Tzovaras G, Fafoulakis F, Pratsas K, Georgopoulou S, Stamatiou G, Hatzitheofilou C. Spinal vs general anesthesia for laparoscopic cholecystectomy: interim analysis of a controlled randomized trial. Arch Surg. 2008 May;143(5):497-501. doi: 10.1001/archsurg.143.5.497.
PubMed 18490561
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Elective Laparoscopic Cholecystectomy in Fit Patients
- ClinicalTrials.gov ID
- NCT00492453
- Acronym / sponsor ID
- SALC / UThessaly 9-04
- Conditions
- Spinal Anesthesia, General Anesthesia, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Collaborators
- Larissa University Hospital
- Study start
- Sep 2004
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 27 Jun 2007 (estimated)
- 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.
The purpose of the study is to assess whether spinal anesthesia is or not superior to the standard general anesthesia for fit patients undergoing laparoscopic cholecystectomy.
Detailed description
Laparoscopic cholecystectomy under regional anesthesia alone has been reported only occasionally in the past; all these reports included patients unfit to receive general anesthesia, mainly patients with severe chronic obstructive airway disease. Regional anesthesia has been used for laparoscopy in fit patients almost exclusively in combination with general anesthesia, in order to extend the analgesic effect during the early postoperative period. Surprisingly, in the era of minimally invasive medicine, regional anesthesia has not gained popularity, and has not been routinely used as a sole method of anesthesia in laparoscopic procedures. It is generally accepted that all laparoscopic procedures are merely a change in access and still require general anesthetic; hence the difference from conventional surgery is likely to be small. This statement is predominantly based on the assumption that laparoscopy necessitates endotracheal intubation to prevent aspiration and respiratory embarrassment secondary to the induction of CO2 pneumoperitoneum which in turn is not well tolerated in a patient who is awake during the procedure. However, it is surprising that regional anesthesia has been successfully used for laparoscopic cholecystectomy in patients unfit to have the procedure under general anesthesia, but has not been tested in fit patients, in whom any presumed risk would be, theoretically, much lower. We have recently shown in a pilot study the feasibility to perform successfully and safely laparoscopic cholecystectomy with low pressure CO2 pneumoperitoneum under spinal anesthesia alone, in fit patients with symptomatic gallstone disease. We have also noticed that spinal anesthesia results in exceptionally minimal postoperative pain. After this pilot study, we designed a controlled randomized trial in order to compare spinal anesthesia with the standard general anesthesia for elective laparoscopic cholecystectomy in fit patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: laparoscopic cholecystectomyLaparoscopic cholecystectomy under spinal anesthesia |
| 2 | Active comparator | Procedure: laparoscopic cholecystectomyLaparoscopic cholecystectomy under general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elective laparoscopic cholecystectomy
- ASA I, II
- BMI< 30
- normal coagulation profile
Key exclusion criteria (4 listed)
- acute cholecystitis / cholangitis / pancreatitis
- previous open surgery in the upper abdomen
- contraindication for pneumoperitoneum
- contraindication for spinal anesthesia (ie spinal deformity)
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 |
|---|---|---|
| laparoscopic cholecystectomyelective laparoscopic cholecystectomy using CO2 pneumoperitoneum under different methods of anesthesia | Procedure or surgery | 1, 2 |
Primary outcome
postoperative pain
Time frame: 24hrs
3 secondary outcomes
complications
Time frame: 30 days
hospital stay
Time frame: time from intervention to discharge
patient satisfaction
Time frame: within 2 weeks from intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
- Background: PubMed 16437265Tzovaras G, Fafoulakis F, Pratsas K, Georgopoulou S, Stamatiou G, Hatzitheofilou C. Laparoscopic cholecystectomy under spinal anesthesia: a pilot study. Surg Endosc. 2006 Apr;20(4):580-2. doi: 10.1007/s00464-005-0405-1. Epub 2006 Jan 25.
- Results publication: PubMed 18490561Tzovaras G, Fafoulakis F, Pratsas K, Georgopoulou S, Stamatiou G, Hatzitheofilou C. Spinal vs general anesthesia for laparoscopic cholecystectomy: interim analysis of a controlled randomized trial. Arch Surg. 2008 May;143(5):497-501. doi: 10.1001/archsurg.143.5.497.
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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.
Constantine Hatzitheofilou, MD study chair
University of Thessaly, School of Medicine
George Tzovaras, MD study director
University of Thessaly, School of Medicine
Frank Fafoulakis, MD principal investigator
University Hospital of Larissa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic cholecystectomy in people with Spinal Anesthesia and General Anesthesia, run by University of Thessaly at 1 site in Greece.
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 4 inclusion and 4 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 14 Jan 2010. 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 Greece. 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?
Contact George Tzovaras, MD (+30 2410 682730, gtzovaras@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 24hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00492453, which also lists 2 linked publications.
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 14 Jan 2010.