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The investigators hypothesis is that perioperative infusion of 0.75 ropivacaine in patients undergoing laparoscopic cholecystectomy may modify the intensity of postoperative pain or the analgesic consumption during the first 24 hours.
Patients scheduled for laparoscopic cholecystectomy were randomly assigned to receive via a subcutaneous catheter 2 ml per hour of 0.75 ropivacaine or same volume of normal saline. The catheter was inserted after induction of general anesthesia and before beginning of surgery and continued for the first 24 postoperative hours. The solutions were administered by means of an elastomeric pump. Before induction of anesthesia metoclopramide 10 mg, ranitidine 50 mg and droperidol 0.75 mg were given intravenously. In the operating room the routine monitoring was applied. Anesthesia was induced with thiopental 5-6 mg/kg, fentanyl 2 μg/kg, and rocuronium 0.6 mg/kg, and maintained with sevoflurane 1-1.5 Minimum Alveolar Concentration (MAC) in a nitrous oxide/oxygen mixture. After induction of anesthesia diclofenac 75 mg I.V was given within 30 min. Before wound closure each hole was infiltrated with 2 ml of ropivacaine 0.75 or normal saline. At the end of surgery neuromuscular block was reversed with sugammadex 2 mg/kg., the patient was extubated and transferred to the Post-anesthesia Care Unit (PACU).
Intra-operatively, the intra-abdominal pressure, the rate of carbon dioxide insufflation and the total amount of carbon dioxide insufflated are recorded every 5 minutes.
Besides the ropivacaine infusion in the operative site, postoperative analgesia is assured in the PACU with paracetamol 1 gr and tramadol 100 mg if Visual Analogue Scale (VAS) score is above 40 mm.In the ward Lonarid tablets are given instead.
VAS values and analgesic consumption are recorded in the PACU, and 2, 4, 8, 24 and 48 hours after surgery.
The catheter is removed 24 hours after surgery. One and three months after surgery patients are interviewed by phone for the presence of pain due to surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine 0.75 | Active Comparator | Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours |
|
| Normal saline | Placebo Comparator | Continuous infusion of normal saline 2 ml/h for 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 0.75 | Drug |
|
| |
| Normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| VAS Score Changes ( Cough) During 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. | 24 h |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores in the Postoperative Care Unit (PACU) 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. | in PACU |
| Pain Scores at Rest 2 h Postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emilia Vassi | St Savvas Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia, St Savas Hospital | Athens | 11522 | Greece | |||
| Aretaieio Hospital |
No plan to share data. The study has been published
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropivacaine 0.75 | Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75 |
| FG001 | Normal Saline | Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
To assess differences in patients' characteristics between the two groups, two-independent samples t-tests for normally distributed variables (age and duration of surgery) and Mann-Whitney tests for abnormally distributed variables (BMI and CO2 total volume consumed) were carried out.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ropivacaine 0.75 | Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75 |
| BG001 | Normal Saline | Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | VAS Score Changes ( Cough) During 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. | 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 | Posted | Mean | Standard Deviation | mm | 24 h |
|
According to study design no adverse events were planned to be collected but in case of adverse events these are routinely included in patient's records for 24 hours postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ropivacaine 0.75 | Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Ropivacaine 0.75 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Argyro Fassoulaki | Aretaieo Hospital University of Athens | +30 6936701333 | fassoula@aretaieio.uoa.gr |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Drug |
|
|
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. |
| 2 h postoperatively |
| Pain Scores 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. | 4 h |
| Pain Scores 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. | 8 h |
| Pain Scores 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. | 24h |
| Pain Scores at Rest 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. | 48 h |
| Pain Scores During Cough in the 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. | PACU |
| Pain Scores 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. | 2 h |
| Pain Scores 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. | 4 h |
| Pain Scores During Cough 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. | 8 h |
| Pain Scores 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. | 48 h |
| Chronic Pain | Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively | one month postoperatively |
| Chronic Pain | Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively | three months |
| Athens |
| 11528 |
| Greece |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline
|
|
| Secondary | Pain Scores in the Postoperative Care Unit (PACU) 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. | 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 | Posted | Mean | Standard Deviation | mm | in PACU |
|
|
|
| Secondary | Pain Scores at Rest 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. | 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 | Posted | Mean | Standard Deviation | mm | 2 h postoperatively |
|
|
|
| Secondary | Pain Scores 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. | 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 | Posted | Mean | Standard Deviation | mm | 4 h |
|
|
|
| Secondary | Pain Scores 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. | 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 | Posted | Mean | Standard Deviation | mm | 8 h |
|
|
|
| Secondary | Pain Scores 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. | 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 | Posted | Mean | Standard Deviation | mm | 24h |
|
|
|
| Secondary | Pain Scores at Rest 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. | 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 | Posted | Mean | Standard Deviation | mm | 48 h |
|
|
|
| Secondary | Pain Scores During Cough in the 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. | 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 | Posted | Mean | Standard Deviation | mm | PACU |
|
|
|
| Secondary | Pain Scores 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. | 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 | Posted | Mean | Standard Deviation | mm | 2 h |
|
|
|
| Secondary | Pain Scores 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. | 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 | Posted | Mean | Standard Deviation | mm | 4 h |
|
|
|
| Secondary | Pain Scores During Cough 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. | 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 | Posted | Mean | Standard Deviation | mm | 8 h |
|
|
|
| Secondary | Pain Scores 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. | 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 | Posted | Mean | Standard Deviation | mm | 48 h |
|
|
|
| Secondary | Chronic Pain | Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively | 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. | Posted | Number | number of participants | one month postoperatively |
|
|
|
| Secondary | Chronic Pain | Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively | 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. | Posted | Number | Number of participants | three months |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Normal Saline | Continuous infusion of normal saline 2 ml/h for 24 hours Normal saline | 0 | 55 | 0 | 55 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |