Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy

Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317510
• Other study ID #: HASEKI-156
• Status: Completed
• Phase: N/A
• First received: December 11, 2014
• Last updated: February 17, 2016
• Start date: December 2014
• Est. completion date: May 2015

Study information

• Verified date: February 2016
• Source: Lütfiye Nuri Burat Government Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Gall stone disease, polyp

Exclusion Criteria:

• Gall bladder cancer

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gall Stone Disease
• Gallstones
• Polyp

Intervention

Procedure:
• combined anesthesia
Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy
• general anesthesia
General anesthesia for laparoscopic cholecystectomy

Locations

Country	Name	City	State
Turkey	Lutfiye NBGH	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Lütfiye Nuri Burat Government Hospital	Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 2 hours	No
Primary	Post-operative Shoulder Pain	Group 1 and Group 2 Post-operative shoulder pain	from end of the operation to postoperative 3 days	No
Secondary	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	up to 2 hours	No
Secondary	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.	pain at postoperative 2nd hour	No
Secondary	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.	pain at postoperative 4th hour	No
Secondary	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.	pain at postoperative 6th hour	No
Secondary	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.	pain at postoperative 12th hour	No
Secondary	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.	pain at postoperative 24th hour	No
Secondary	Intra-operative Shoulder Pain	Group 1 and Group 2 Intra-operative shoulder pain	during operation time, up to 2 hours	No
Secondary	Urinary Retention	Group 1 and Group 2 Urinary retention	from end of the operation to postoperative 1 day	No
Secondary	Nausea/Vomiting	Group 1 and group 2 nausea/vomiting	from end of the operation to postoperative 1 day	No
Secondary	Headache	Group 1 and Group 2 Headache	from end of the operation to postoperative 3 days	No