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NCT Number: NCT02317510

Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Gall Stone Disease Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyp Polyps

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lutfiye NBGH

Istanbul, 34300, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gall stone disease, polyp

Exclusion criteria

  • Gall bladder cancer

Treatment and study plan

combined anesthesia

Procedure

Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy

General Anesthesia

Procedure

General anesthesia for laparoscopic cholecystectomy

Primary outcomes

  1. 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

  2. Post-operative Shoulder Pain

    Time frame: from end of the operation to postoperative 3 days

    Group 1 and Group 2 Post-operative shoulder pain

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Intra-operative Shoulder Pain

    Time frame: during operation time, up to 2 hours

    Group 1 and Group 2 Intra-operative shoulder pain

  8. Urinary Retention

    Time frame: from end of the operation to postoperative 1 day

    Group 1 and Group 2 Urinary retention

  9. Nausea/Vomiting

    Time frame: from end of the operation to postoperative 1 day

    Group 1 and group 2 nausea/vomiting

  10. Headache

    Time frame: from end of the operation to postoperative 3 days

    Group 1 and Group 2 Headache

Sponsors and collaborators

Lead sponsor

Lütfiye Nuri Burat Government Hospital

Other Gov

Collaborators

  • Haseki Training and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 16, 2014
Registry last updated
Mar 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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