Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy

February 17, 2016 updated by: TURGUT DONMEZ, Lütfiye Nuri Burat Government Hospital

Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy: a Prospective, Randomized 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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34300
        • Lutfiye NBGH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gall stone disease, polyp

Exclusion Criteria:

  • Gall bladder cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: group 1
Laparoscopic cholecystectomy in General Anesthesia
Procedure: combined anesthesia
Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy
ACTIVE_COMPARATOR: group 2
Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).
Procedure: general anesthesia
General anesthesia for laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 2 hours
Post-operative Shoulder Pain
Time Frame: from end of the operation to postoperative 3 days
Group 1 and Group 2 Post-operative shoulder pain
from end of the operation to postoperative 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Anaesthesia
Time Frame: up to 2 hours
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
up to 2 hours
Post-operative Abdominal Pain 2nd Hour
Time Frame: pain at postoperative 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.
pain at postoperative 2nd hour
Post-operative Abdominal Pain 4th Hour
Time Frame: pain at postoperative 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.
pain at postoperative 4th hour
Post-operative Abdominal Pain 6th Hour
Time Frame: pain at postoperative 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.
pain at postoperative 6th hour
Post-operative Abdominal Pain 12th Hour
Time Frame: pain at postoperative 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.
pain at postoperative 12th hour
Post-operative Abdominal Pain 24th Hour
Time Frame: pain at postoperative 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.
pain at postoperative 24th hour
Intra-operative Shoulder Pain
Time Frame: during operation time, up to 2 hours
Group 1 and Group 2 Intra-operative shoulder pain
during operation time, up to 2 hours
Urinary Retention
Time Frame: from end of the operation to postoperative 1 day
Group 1 and Group 2 Urinary retention
from end of the operation to postoperative 1 day
Nausea/Vomiting
Time Frame: from end of the operation to postoperative 1 day
Group 1 and group 2 nausea/vomiting
from end of the operation to postoperative 1 day
Headache
Time Frame: from end of the operation to postoperative 3 days
Group 1 and Group 2 Headache
from end of the operation to postoperative 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lütfiye Nuri Burat Government Hospital

Collaborators

Haseki Training and Research Hospital

Investigators

  • Principal Investigator: Turgut Donmez, operator MD, Lutfiye NBGH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

December 11, 2014

First Submitted That Met QC Criteria

December 15, 2014

First Posted (ESTIMATE)

December 16, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 15, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HASEKI-156

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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