Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy

Not Applicable

Completed

Conditions: Polyp
Gall Stone Disease

Interventions: Procedure: general anesthesia
Procedure: combined anesthesia

Registration Number: NCT02317510

Lead Sponsor: Lütfiye Nuri Burat Government Hospital

Brief 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.

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

Inclusion Criteria

Gall stone disease, polyp

Exclusion Criteria

Gall bladder cancer

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 2	general anesthesia	Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).
group 1	combined anesthesia	Laparoscopic cholecystectomy in General Anesthesia

Primary Outcome Measures

Name	Time	Method
Duration of Operation	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	from end of the operation to postoperative 3 days	Group 1 and Group 2 Post-operative shoulder pain

Secondary Outcome Measures

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