Trial Outcomes & Findings for Analgesia in Laparoscopic Cholecystectomy (NCT NCT01388946)

NCT ID: NCT01388946

Last Updated: 2016-07-06

Results Overview

Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 110 participants
• Primary outcome timeframe: 24 h
• Results posted on: 2016-07-06

Participant Flow

Participant milestones

Measure	Ropivacaine 0.75 Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
Overall Study STARTED	55	55
Overall Study COMPLETED	49	52
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analgesia in Laparoscopic Cholecystectomy

Baseline characteristics by cohort

Measure	Ropivacaine 0.75 n=55 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=55 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline	Total n=110 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants	48 Participants n=7 Participants	97 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	51 years STANDARD_DEVIATION 11.2 • n=5 Participants	48 years STANDARD_DEVIATION 12.5 • n=7 Participants	50 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	41 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Greece	55 participants n=5 Participants	55 participants n=7 Participants	110 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 h

Population: Fifty patients in the Ropivacaine group were analyzed for the primary (VAS score at cough) and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery

Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

Outcome measures

Measure	Ropivacaine 0.75 n=50 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=52 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
VAS Score Changes ( Cough) During 24 h Postoperatively	32 mm Standard Deviation 26	31 mm Standard Deviation 25

SECONDARY outcome

Timeframe: in PACU

Population: Below is the mean and standard deviation of the VAS scores in PACU at rest Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery

Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

Outcome measures

Measure	Ropivacaine 0.75 n=50 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=52 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
Pain Scores in the Postoperative Care Unit (PACU) at Rest	36 mm Standard Deviation 25	46 mm Standard Deviation 21

SECONDARY outcome

Timeframe: 2 h postoperatively

Population: Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery. Below are the VAS values (mean and standard deviation) 2 h postoperatively at rest

Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

Outcome measures

Measure	Ropivacaine 0.75 n=50 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=52 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
Pain Scores at Rest 2 h Postoperatively	26 mm Standard Deviation 21	30 mm Standard Deviation 23

SECONDARY outcome

Timeframe: 4 h

Population: Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 4 h postoperatively

Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

Outcome measures

Measure	Ropivacaine 0.75 n=50 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=52 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
Pain Scores at Rest 4 h Postoperatively	16 mm Standard Deviation 18	22 mm Standard Deviation 20

SECONDARY outcome

Timeframe: 8 h

Population: Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 8 h postoperatively

Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

Outcome measures

Measure	Ropivacaine 0.75 n=50 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=52 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
Pain Scores at Rest 8 h Postoperatively	17 mm Standard Deviation 22	20 mm Standard Deviation 21

SECONDARY outcome

Timeframe: 24h

Population: Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 24 h postoperatively

Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

Outcome measures

Measure	Ropivacaine 0.75 n=50 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=52 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
Pain Scores at Rest 24 h Postoperatively	14 mm Standard Deviation 16	15 mm Standard Deviation 21

SECONDARY outcome

Timeframe: 48 h

Population: 50 patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. 1 patient in this group presented ileus after the first 24 h assessment, remaining 49 patients for assessment at 48 hours postoperatively Below are the VAS values (mean and standard deviation) at rest 48 hours postoperatively

Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

Outcome measures

Measure	Ropivacaine 0.75 n=49 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=52 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
Pain Scores at Rest 48 h Postoperatively	8 mm Standard Deviation 11	12 mm Standard Deviation 15

SECONDARY outcome

Timeframe: PACU

Population: Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough in PACU

Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

Outcome measures

Measure	Ropivacaine 0.75 n=50 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=52 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
Pain Scores During Cough in the PACU	42 mm Standard Deviation 27	55 mm Standard Deviation 24

SECONDARY outcome

Timeframe: 2 h

Population: Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 2 h postoperatively

Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

Outcome measures

Measure	Ropivacaine 0.75 n=50 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=52 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
Pain Scores During Cough 2 h Postoperatively	36 mm Standard Deviation 27	55 mm Standard Deviation 24

SECONDARY outcome

Timeframe: 4 h

Population: Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 4 h postoperatively

Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

Outcome measures

Measure	Ropivacaine 0.75 n=50 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=52 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
Pain Scores During Cough 4 h Postoperatively	25 mm Standard Deviation 19	34 mm Standard Deviation 23

SECONDARY outcome

Timeframe: 8 h

Population: Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) 8 h postoperatively

Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

Outcome measures

Measure	Ropivacaine 0.75 n=50 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=52 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
Pain Scores During Cough 8 h Postoperatively	29 mm Standard Deviation 25	34 mm Standard Deviation 24

SECONDARY outcome

Timeframe: 48 h

Population: Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient in this group presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 48 h postoperatively

Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

Outcome measures

Measure	Ropivacaine 0.75 n=49 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=52 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
Pain Scores During Cough 48 h Postoperatively	18 mm Standard Deviation 17	26 mm Standard Deviation 21

SECONDARY outcome

Timeframe: one month postoperatively

Population: Below the number of patients with pain one month postoperatively For the chronic pain assessment in the control group we had two dropouts as contact for two patients was not feasible.

Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively

Outcome measures

Measure	Ropivacaine 0.75 n=49 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=50 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
Chronic Pain	5 number of participants	7 number of participants

SECONDARY outcome

Timeframe: three months

Population: Below the number of patients with pain three months postoperatively. For the chronic pain assessment in the control group we had two dropouts as contact for two patients was not feasible.

Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively

Outcome measures

Measure	Ropivacaine 0.75 n=49 Participants Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75	Normal Saline n=50 Participants Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline
Chronic Pain	2 Number of participants	4 Number of participants

Adverse Events

Ropivacaine 0.75

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Argyro Fassoulaki

Aretaieo Hospital University of Athens

Phone: +30 6936701333

Email: fassoula@aretaieio.uoa.gr

Results disclosure agreements

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