Gall Stone DiseaseNCT02317510

Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy

A study testing combined anesthesia and general anesthesia in people with Gall Stone Disease and Polyp, run by Lütfiye Nuri Burat Government Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Gall Stone Disease, Polyp
What is being tested?: combined anesthesia and general anesthesia
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Dec 2014to May 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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Gall stone disease, polyp

Who cannot join

Gall bladder cancer

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Lutfiye NBGH
Istanbul, 34300

Other trials in Turkey (Türkiye)

About this study

Official title: Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy: a Prospective, Randomized Study

Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia , postoperative complications, pain score and duration of operation time will record.

Read the detailed description

Objective of study : The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia.

Material and methods : Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia : abdominal discomfortable, shoulder pain, abdominal pain, nausea, anxiety, dermatomal level of sensory blockade, respiratory depression. We compare between two group; shoulder pain, postoperative complications, pain score, duration of operation time and length of hospital stay.

Fifty patients will select prospectively for LC, under low pressure (10 mm Hg) pneumoperitoneum and under combined anesthesia and general anesthesia. Spinal anaesthesia was performed at L1-L2 interspace using 2 ml of 0.5% (10 mg) hyperbaric Bupivacaine mixed with 0.5ml (25 micrograms) of Fentanyl. Epidural catheter was inserted at L1- L2 interspace too.

Conditions: Gall Stone Disease, Polyp
Being tested: combined anesthesia, general anesthesia
Keywords: Combined anesthesia, General anesthesia, Laparoscopic cholecystectomy
Medical subject headings: Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

combined anesthesiaProcedure or surgery
Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy
general anesthesiaProcedure or surgery
General anesthesia for laparoscopic cholecystectomy

Study groups in NCT02317510
Study group	Role	What they receive
group 1	Active comparator	Laparoscopic cholecystectomy in General Anesthesia Receives: Procedure: combined anesthesia
group 2	Active comparator	Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). Receives: Procedure: general anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Operation
group 1:surgical operation time is 20 minutes minimum and maximum 55 minutes. Mean operation time 36.56 minutes group 2:surgical operation time is 24 minutes minimum and maximum 53 minutes. Mean operation time 30.75 minutes
Measured: up to 2 hours
Post-operative Shoulder Pain
Group 1 and Group 2 Post-operative shoulder pain
Measured: from end of the operation to postoperative 3 days

Secondary outcomes (10)

Duration of Anaesthesia
Group 1 minimum 42 minutes and maximum 83 minutes.mean duration of anaesthesia 60.17 and Group 2 minimum 45 minutes and maximum 82 minutes mean duration of anaesthesia 60.23
Measured: up to 2 hours
Post-operative Abdominal Pain 2nd Hour
VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Measured: pain at postoperative 2nd hour
Post-operative Abdominal Pain 4th Hour
VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Measured: pain at postoperative 4th hour
Post-operative Abdominal Pain 6th Hour
VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Measured: pain at postoperative 6th hour
Post-operative Abdominal Pain 12th Hour
VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Measured: pain at postoperative 12th hour
Post-operative Abdominal Pain 24th Hour
VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Measured: pain at postoperative 24th hour
Intra-operative Shoulder Pain
Group 1 and Group 2 Intra-operative shoulder pain
Measured: during operation time, up to 2 hours
Urinary Retention
Group 1 and Group 2 Urinary retention
Measured: from end of the operation to postoperative 1 day
Nausea/Vomiting
Group 1 and group 2 nausea/vomiting
Measured: from end of the operation to postoperative 1 day
Headache
Group 1 and Group 2 Headache
Measured: from end of the operation to postoperative 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014May 2015

First posted16 Dec 2014 (estimated)
Study startDec 2014
Primary completionFeb 2015
Study completionMay 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gall Stone DiseaseStudies 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02317510
Sponsor's protocol ID: HASEKI-156
Status last verified: Feb 2016
First submitted: 11 Dec 2014
Last updated: 15 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bessa SS, Katri KM, Abdel-Salam WN, El-Kayal el-SA, Tawfik TA. Spinal versus general anesthesia for day-case laparoscopic cholecystectomy: a prospective randomized study. J Laparoendosc Adv Surg Tech A. 2012 Jul-Aug;22(6):550-5. doi: 10.1089/lap.2012.0110. Epub 2012 Jun 11.
PubMed 22686181

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
Recruiting
Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease
Cholecystectomy, Robotic, Cholecystectomy, Laparoscopic
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Active, not recruiting
RELIEF-pathway in Patients With Upper Abdominal Pain
Abdominal Pain, Gallstone; Colic
Recruiting
ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
Cholecystolithiasis, Common Bile Duct Gall Stones

All Gall Stone Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy: a Prospective, Randomized Study
ClinicalTrials.gov ID: NCT02317510
Acronym / sponsor ID: HASEKI-156
Conditions: Gall Stone Disease, Polyp
Keywords: Combined anesthesia, General anesthesia, Laparoscopic cholecystectomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Lütfiye Nuri Burat Government HospitalOther government
Collaborators: Haseki Training and Research Hospital
Study start: Dec 2014
Primary completion: Feb 2015 (actual)
Study completion: May 2015 (actual)
First posted: 16 Dec 2014 (estimated)
Results: Posted 23 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
group 1	Active comparator	Procedure: combined anesthesiaLaparoscopic cholecystectomy in General Anesthesia
group 2	Active comparator	Procedure: general anesthesiaLaparoscopic cholecystectomy in combined anesthesia (Spino epidural).

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Gall stone disease, polyp

Key exclusion criteria (1 listed)

Gall bladder cancer

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
combined anesthesiaCombined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Procedure or surgery	group 1
general anesthesiaGeneral anesthesia for laparoscopic cholecystectomy	Procedure or surgery	group 2

Primary outcome

Duration of Operation
Time frame: up to 2 hours
group 1:surgical operation time is 20 minutes minimum and maximum 55 minutes. Mean operation time 36.56 minutes group 2:surgical operation time is 24 minutes minimum and maximum 53 minutes. Mean operation time 30.75 minutes
Post-operative Shoulder Pain
Time frame: from end of the operation to postoperative 3 days
Group 1 and Group 2 Post-operative shoulder pain

10 secondary outcomes

Duration of Anaesthesia
Time frame: up to 2 hours
Post-operative Abdominal Pain 2nd Hour
Time frame: pain at postoperative 2nd hour
Post-operative Abdominal Pain 4th Hour
Time frame: pain at postoperative 4th hour
Post-operative Abdominal Pain 6th Hour
Time frame: pain at postoperative 6th hour
Post-operative Abdominal Pain 12th Hour
Time frame: pain at postoperative 12th hour
Post-operative Abdominal Pain 24th Hour
Time frame: pain at postoperative 24th hour
Intra-operative Shoulder Pain
Time frame: during operation time, up to 2 hours
Urinary Retention
Time frame: from end of the operation to postoperative 1 day
Nausea/Vomiting
Time frame: from end of the operation to postoperative 1 day
Headache
Time frame: from end of the operation to postoperative 3 days

Results and safety

Results posted to the registry on 23 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	25	25
Group 2	25	24

Primary outcome: Duration of Operation

Time frame: up to 2 hours. Mean (Standard Deviation). Unit: minutes

Measure	Group 1 n = 25	Group 2 n = 24
Value	36.56 (10.627)	30.75 (7.502)

Population analysed: All patients have gall bladder disease who are between 18-90 years old.

Primary outcome: Post-operative Shoulder Pain

Time frame: from end of the operation to postoperative 3 days. Number. Unit: participants

Measure	Group 1 n = 25	Group 2 n = 24
shoulder pain yes	15	6
shoulder pain no	10	18

Population analysed: All patients have gall bladder disease who are between 18-90 years old

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: December 2014-may 2015. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 25 (0%)	21 of 25 (84%)	Not reported
Group 2	0 of 24 (0%)	16 of 24 (66.7%)	Not reported

Limitations and caveats (from the sponsor): one patients had dural injury. Because of this that patient had released.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22686181Bessa SS, Katri KM, Abdel-Salam WN, El-Kayal el-SA, Tawfik TA. Spinal versus general anesthesia for day-case laparoscopic cholecystectomy: a prospective randomized study. J Laparoendosc Adv Surg Tech A. 2012 Jul-Aug;22(6):550-5. doi: 10.1089/lap.2012.0110. Epub 2012 Jun 11.

Related trials for Gall Stone Disease

Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
Recruiting
Surgical Techniques: Robotic Versus Conventional Laparoscopic Cholecystectomy IN Benign Gallbladder Disease
Cholecystectomy, Robotic, Cholecystectomy, Laparoscopic
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Active, not recruiting
RELIEF-pathway in Patients With Upper Abdominal Pain
Abdominal Pain, Gallstone; Colic
Recruiting
ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
Cholecystolithiasis, Common Bile Duct Gall Stones

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.

Turgut Donmez, operator MD principal investigator

Lutfiye NBGH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing combined anesthesia and general anesthesia in people with Gall Stone Disease and Polyp, run by Lütfiye Nuri Burat Government Hospital at 1 site in Turkey (Türkiye).

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 1 inclusion and 1 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 15 Mar 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 Turkey (Türkiye). 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 23 Jul 2015). 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?

Duration of Operation (time frame: up to 2 hours). The study lists 2 primary outcomes in all. 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 NCT02317510, which also lists 1 linked publication.

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 15 Mar 2016.