Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy

• Sponsor: Lütfiye Nuri Burat Government Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02317510
• Collaborator: Haseki Training and Research Hospital (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 10.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gall Stone Disease; Polyp	Procedure: combined anesthesia; Procedure: general anesthesia	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy: a Prospective, Randomized Study
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. Intra-operative Shoulder Pain [during operation time, up to 2 hours]

   Group 1 and Group 2 Intra-operative shoulder pain

8. Urinary Retention [from end of the operation to postoperative 1 day]

   Group 1 and Group 2 Urinary retention

9. Nausea/Vomiting [from end of the operation to postoperative 1 day]

   Group 1 and group 2 nausea/vomiting

10. Headache [from end of the operation to postoperative 3 days]

    Group 1 and Group 2 Headache

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Gall stone disease, polyp

Exclusion Criteria:

• Gall bladder cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lutfiye NBGH	İstanbul		Turkey	34300

Sponsors and Collaborators

• Lütfiye Nuri Burat Government Hospital
• Haseki Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: TURGUT DONMEZ, Medical Doctor, General Surgeon, Lütfiye Nuri Burat Government Hospital
• ClinicalTrials.gov Identifier: NCT02317510
• Other Study ID Numbers: HASEKI-156
• First Posted: Dec 16, 2014
• Last Update Posted: Mar 15, 2016
• Last Verified: Feb 1, 2016

• Keywords provided by TURGUT DONMEZ, Medical Doctor, General Surgeon, Lütfiye Nuri Burat Government Hospital: Combined anesthesia; General anesthesia; Laparoscopic cholecystectomy
• Additional relevant MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis; Anesthetics

Study Results

Participant Flow

Recruitment Details	medical clinic

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia	Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
Period Title: Overall Study
STARTED	25	25
COMPLETED	25	24
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Group 1	Group 2	Total
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy	Total of all reporting groups
Overall Participants	25	24	49
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	46 (13.38)	45.5 (13.60)	46 (13.35)
Sex: Female, Male (Count of Participants)
Female	7 28%	6 25%	13 26.5%
Male	18 72%	18 75%	36 73.5%
Region of Enrollment (participants) [Number]
Turkey	25 100%	24 100%	49 100%
BMI (kg/m^2) [Median (Standard Deviation) ]
Median (Standard Deviation) [kg/m^2]	28.66 (4.49)	30.68 (3.59)	29.55 (4.14)
ASA (American Society of Anesthesiologists scores) (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	1	1	1

Outcome Measures

1. Primary Outcome

Title	Duration of Operation
Description	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
Time Frame	up to 2 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy
Measure Participants	25	24
Mean (Standard Deviation) [minutes]	36.56 (10.627)	30.75 (7.502)

2. Secondary Outcome

Title	Duration of Anaesthesia
Description	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
Time Frame	up to 2 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia	Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
Measure Participants	25	24
Mean (Standard Deviation) [minutes]	60.17 (10.73)	60.23 (7.87)

3. Secondary Outcome

Title	Post-operative Abdominal Pain 2nd Hour
Description	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.
Time Frame	pain at postoperative 2nd hour

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia	Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
Measure Participants	25	24
Least Squares Mean (Standard Deviation) [units on a scale]	7 (0.71)	1 (0.51)

4. Secondary Outcome

Title	Post-operative Abdominal Pain 4th Hour
Description	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.
Time Frame	pain at postoperative 4th hour

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia	Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
Measure Participants	25	24
Least Squares Mean (Standard Deviation) [units on a scale]	6 (0.71)	2 (0.57)

5. Secondary Outcome

Title	Post-operative Abdominal Pain 6th Hour
Description	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.
Time Frame	pain at postoperative 6th hour

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia	Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
Measure Participants	25	24
Least Squares Mean (Standard Deviation) [units on a scale]	4 (0.45)	4 (0.6)

6. Secondary Outcome

Title	Post-operative Abdominal Pain 12th Hour
Description	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.
Time Frame	pain at postoperative 12th hour

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia	Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
Measure Participants	25	24
Least Squares Mean (Standard Deviation) [units on a scale]	3 (0.72)	1 (0.46)

7. Secondary Outcome

Title	Post-operative Abdominal Pain 24th Hour
Description	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.
Time Frame	pain at postoperative 24th hour

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia	Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
Measure Participants	25	24
Least Squares Mean (Standard Deviation) [units on a scale]	2 (0.52)	1 (0.50)

8. Primary Outcome

Title	Post-operative Shoulder Pain
Description	Group 1 and Group 2 Post-operative shoulder pain
Time Frame	from end of the operation to postoperative 3 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia	Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
Measure Participants	25	24
shoulder pain yes	15 60%	6 25%
shoulder pain no	10 40%	18 75%

9. Secondary Outcome

Title	Intra-operative Shoulder Pain
Description	Group 1 and Group 2 Intra-operative shoulder pain
Time Frame	during operation time, up to 2 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia	Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
Measure Participants	25	24
shoulder pain yes	0 0%	3 12.5%
shoulder pain no	25 100%	21 87.5%

10. Secondary Outcome

Title	Urinary Retention
Description	Group 1 and Group 2 Urinary retention
Time Frame	from end of the operation to postoperative 1 day

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia	Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
Measure Participants	25	24
urinary retention yes	0 0%	3 12.5%
urinary retention no	25 100%	21 87.5%

11. Secondary Outcome

Title	Nausea/Vomiting
Description	Group 1 and group 2 nausea/vomiting
Time Frame	from end of the operation to postoperative 1 day

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia	Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
Measure Participants	25	24
nausea/vomiting yes	5 20%	1 4.2%
nausea/vomiting no	20 80%	23 95.8%

12. Secondary Outcome

Title	Headache
Description	Group 1 and Group 2 Headache
Time Frame	from end of the operation to postoperative 3 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia	Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
Measure Participants	25	24
headache yes	0 0%	2 8.3%
headache no	25 100%	22 91.7%

Adverse Events

Time Frame	December 2014-may 2015
Arm/Group Title	Group 1		Group 2
Arm/Group Description	Laparoscopic cholecystectomy in General Anesthesia		Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
All Cause Mortality
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)
Blood and lymphatic system disorders
embolism	0/25 (0%)	0	0/24 (0%)	0
Injury, poisoning and procedural complications
mean vascular injury	0/25 (0%)	0	0/24 (0%)	0
choledocal injury	0/25 (0%)	0	0/24 (0%)	0
Other (Not Including Serious) Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/25 (84%)		16/24 (66.7%)
Cardiac disorders
Hypotension	1/25 (4%)	1	1/24 (4.2%)	1
Gastrointestinal disorders
Nausea/vomiting	5/25 (20%)	5	1/24 (4.2%)	1
Nervous system disorders
post-operative shoulder pain	15/25 (60%)	15	6/24 (25%)	6
Headache	0/25 (0%)	0	2/24 (8.3%)	2
intra-operative shoulder pain	0/25 (0%)	0	3/24 (12.5%)	3
Renal and urinary disorders
Urinary retansion	0/25 (0%)	0	3/24 (12.5%)	3

Limitations/Caveats

one patients had dural injury. Because of this that patient had released.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.