Trial Outcomes & Findings for Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy (NCT NCT02317510)

NCT ID: NCT02317510

Last Updated: 2016-03-15

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: up to 2 hours
• Results posted on: 2016-03-15

Participant Flow

medical clinic

Participant milestones

Measure	Group 1 Laparoscopic cholecystectomy in General Anesthesia	Group 2 Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
Overall Study STARTED	25	25
Overall Study COMPLETED	25	24
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Group 1 Laparoscopic cholecystectomy in General Anesthesia	Group 2 Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
Overall Study Adverse Event	0	1

Baseline Characteristics

Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy

Baseline characteristics by cohort

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Group 2 n=24 Participants Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy	Total n=49 Participants Total of all reporting groups
Age, Continuous	46 years STANDARD_DEVIATION 13.38 • n=93 Participants	45.5 years STANDARD_DEVIATION 13.60 • n=4 Participants	46 years STANDARD_DEVIATION 13.35 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	6 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	18 Participants n=4 Participants	36 Participants n=27 Participants
Region of Enrollment Turkey	25 participants n=93 Participants	24 participants n=4 Participants	49 participants n=27 Participants
BMI	28.66 kg/m^2 STANDARD_DEVIATION 4.49 • n=93 Participants	30.68 kg/m^2 STANDARD_DEVIATION 3.59 • n=4 Participants	29.55 kg/m^2 STANDARD_DEVIATION 4.14 • n=27 Participants
ASA (American Society of Anesthesiologists scores)	1 units on a scale n=93 Participants	1 units on a scale n=4 Participants	1 units on a scale n=27 Participants

PRIMARY outcome

Timeframe: up to 2 hours

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

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

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Group 2 n=24 Participants Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy
Duration of Operation	36.56 minutes Standard Deviation 10.627	30.75 minutes Standard Deviation 7.502

PRIMARY outcome

Timeframe: from end of the operation to postoperative 3 days

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

Group 1 and Group 2 Post-operative shoulder pain

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Group 2 n=24 Participants Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy
Post-operative Shoulder Pain shoulder pain no	10 participants	18 participants
Post-operative Shoulder Pain shoulder pain yes	15 participants	6 participants

SECONDARY outcome

Timeframe: up to 2 hours

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

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

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Group 2 n=24 Participants Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy
Duration of Anaesthesia	60.17 minutes Standard Deviation 10.73	60.23 minutes Standard Deviation 7.87

SECONDARY outcome

Timeframe: pain at postoperative 2nd hour

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

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.

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Group 2 n=24 Participants Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy
Post-operative Abdominal Pain 2nd Hour	7 units on a scale Standard Deviation 0.71	1 units on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: pain at postoperative 4th hour

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

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.

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Group 2 n=24 Participants Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy
Post-operative Abdominal Pain 4th Hour	6 units on a scale Standard Deviation 0.71	2 units on a scale Standard Deviation 0.57

SECONDARY outcome

Timeframe: pain at postoperative 6th hour

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

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.

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Group 2 n=24 Participants Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy
Post-operative Abdominal Pain 6th Hour	4 units on a scale Standard Deviation 0.45	4 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: pain at postoperative 12th hour

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

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.

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Group 2 n=24 Participants Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy
Post-operative Abdominal Pain 12th Hour	3 units on a scale Standard Deviation 0.72	1 units on a scale Standard Deviation 0.46

SECONDARY outcome

Timeframe: pain at postoperative 24th hour

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

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.

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Group 2 n=24 Participants Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy
Post-operative Abdominal Pain 24th Hour	2 units on a scale Standard Deviation 0.52	1 units on a scale Standard Deviation 0.50

SECONDARY outcome

Timeframe: during operation time, up to 2 hours

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

Group 1 and Group 2 Intra-operative shoulder pain

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Group 2 n=24 Participants Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy
Intra-operative Shoulder Pain shoulder pain yes	0 participants	3 participants
Intra-operative Shoulder Pain shoulder pain no	25 participants	21 participants

SECONDARY outcome

Timeframe: from end of the operation to postoperative 1 day

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

Group 1 and Group 2 Urinary retention

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Group 2 n=24 Participants Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy
Urinary Retention urinary retention yes	0 participants	3 participants
Urinary Retention urinary retention no	25 participants	21 participants

SECONDARY outcome

Timeframe: from end of the operation to postoperative 1 day

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

Group 1 and group 2 nausea/vomiting

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Group 2 n=24 Participants Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy
Nausea/Vomiting nausea/vomiting yes	5 participants	1 participants
Nausea/Vomiting nausea/vomiting no	20 participants	23 participants

SECONDARY outcome

Timeframe: from end of the operation to postoperative 3 days

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

Group 1 and Group 2 Headache

Outcome measures

Measure	Group 1 n=25 Participants Laparoscopic cholecystectomy in General Anesthesia combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy	Group 2 n=24 Participants Laparoscopic cholecystectomy in combined anesthesia (Spino epidural). general anesthesia: General anesthesia for laparoscopic cholecystectomy
Headache headache yes	0 participants	2 participants
Headache headache no	25 participants	22 participants

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 n=25 participants at risk Laparoscopic cholecystectomy in General Anesthesia	Group 2 n=24 participants at risk Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
Injury, poisoning and procedural complications mean vascular injury	0.00% 0/25 • December 2014-may 2015	0.00% 0/24 • December 2014-may 2015
Blood and lymphatic system disorders embolism	0.00% 0/25 • December 2014-may 2015	0.00% 0/24 • December 2014-may 2015
Injury, poisoning and procedural complications choledocal injury	0.00% 0/25 • December 2014-may 2015	0.00% 0/24 • December 2014-may 2015

Other adverse events

Measure	Group 1 n=25 participants at risk Laparoscopic cholecystectomy in General Anesthesia	Group 2 n=24 participants at risk Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
Cardiac disorders Hypotension	4.0% 1/25 • Number of events 1 • December 2014-may 2015	4.2% 1/24 • Number of events 1 • December 2014-may 2015
Nervous system disorders post-operative shoulder pain	60.0% 15/25 • Number of events 15 • December 2014-may 2015	25.0% 6/24 • Number of events 6 • December 2014-may 2015
Renal and urinary disorders Urinary retansion	0.00% 0/25 • December 2014-may 2015	12.5% 3/24 • Number of events 3 • December 2014-may 2015
Gastrointestinal disorders Nausea/vomiting	20.0% 5/25 • Number of events 5 • December 2014-may 2015	4.2% 1/24 • Number of events 1 • December 2014-may 2015
Nervous system disorders Headache	0.00% 0/25 • December 2014-may 2015	8.3% 2/24 • Number of events 2 • December 2014-may 2015
Nervous system disorders intra-operative shoulder pain	0.00% 0/25 • December 2014-may 2015	12.5% 3/24 • Number of events 3 • December 2014-may 2015

Additional Information

Dr. Turgut Donmez

Lutfiye NBGH

Phone: 00905347400967

Email: surgeont73@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place