Chronic Postoperative Pain, Pain, Postoperative
Conditions
Keywords
acute postoperative pain, late pain, chronic pain, wound irrigation with local anesthetic
Brief summary
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.
Detailed description
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.
Interventions
DRUGRopivacaine 0.75
DRUGNormal saline
Sponsors
University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 30-70 years American Society of Anesthesiology (ASA) physical status I-III * Scheduled for laparoscopic cholecystectomy
Exclusion criteria
* Patients with chronic pain and/or on analgesics for the last month, * Patients with central nervous, kidney and liver disease, or allergy to local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS Score Changes ( Cough) During 24 h Postoperatively | 24 h | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores at Rest 2 h Postoperatively | 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. |
| Pain Scores at Rest 4 h Postoperatively | 4 h | 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. |
| Pain Scores at Rest 8 h Postoperatively | 8 h | 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. |
| Pain Scores at Rest 24 h Postoperatively | 24h | 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. |
| Pain Scores at Rest 48 h Postoperatively | 48 h | 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. |
| Pain Scores in the Postoperative Care Unit (PACU) at Rest | 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. |
| Pain Scores During Cough 2 h Postoperatively | 2 h | 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. |
| Pain Scores During Cough 4 h Postoperatively | 4 h | 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. |
| Pain Scores During Cough 8 h Postoperatively | 8 h | 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. |
| Pain Scores During Cough 48 h Postoperatively | 48 h | 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. |
| Chronic Pain | one month postoperatively | Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively |
| Pain Scores During Cough in the PACU | 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. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ropivacaine 0.75 Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Ropivacaine 0.75 | 55 |
| Normal Saline Continuous infusion of normal saline 2 ml/h for 24 hours
Normal saline | 55 |
| Total | 110 |
Baseline characteristics
| Characteristic | Normal Saline | Ropivacaine 0.75 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 6 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 49 Participants | 97 Participants |
| Age, Continuous | 48 years STANDARD_DEVIATION 12.5 | 51 years STANDARD_DEVIATION 11.2 | 50 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment Greece | 55 participants | 55 participants | 110 participants |
| Sex: Female, Male Female | 41 Participants | 38 Participants | 79 Participants |
| Sex: Female, Male Male | 14 Participants | 17 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine 0.75 | VAS Score Changes ( Cough) During 24 h Postoperatively | 32 mm | Standard Deviation 26 |
| Normal Saline | VAS Score Changes ( Cough) During 24 h Postoperatively | 31 mm | Standard Deviation 25 |
Secondary
Chronic Pain
Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ropivacaine 0.75 | Chronic Pain | 2 Number of participants |
| Normal Saline | Chronic Pain | 4 Number of participants |
Secondary
Chronic Pain
Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ropivacaine 0.75 | Chronic Pain | 5 number of participants |
| Normal Saline | Chronic Pain | 7 number of participants |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine 0.75 | Pain Scores at Rest 24 h Postoperatively | 14 mm | Standard Deviation 16 |
| Normal Saline | Pain Scores at Rest 24 h Postoperatively | 15 mm | Standard Deviation 21 |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine 0.75 | Pain Scores at Rest 2 h Postoperatively | 26 mm | Standard Deviation 21 |
| Normal Saline | Pain Scores at Rest 2 h Postoperatively | 30 mm | Standard Deviation 23 |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine 0.75 | Pain Scores at Rest 48 h Postoperatively | 8 mm | Standard Deviation 11 |
| Normal Saline | Pain Scores at Rest 48 h Postoperatively | 12 mm | Standard Deviation 15 |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine 0.75 | Pain Scores at Rest 4 h Postoperatively | 16 mm | Standard Deviation 18 |
| Normal Saline | Pain Scores at Rest 4 h Postoperatively | 22 mm | Standard Deviation 20 |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine 0.75 | Pain Scores at Rest 8 h Postoperatively | 17 mm | Standard Deviation 22 |
| Normal Saline | Pain Scores at Rest 8 h Postoperatively | 20 mm | Standard Deviation 21 |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine 0.75 | Pain Scores During Cough 2 h Postoperatively | 36 mm | Standard Deviation 27 |
| Normal Saline | Pain Scores During Cough 2 h Postoperatively | 55 mm | Standard Deviation 24 |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine 0.75 | Pain Scores During Cough 48 h Postoperatively | 18 mm | Standard Deviation 17 |
| Normal Saline | Pain Scores During Cough 48 h Postoperatively | 26 mm | Standard Deviation 21 |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine 0.75 | Pain Scores During Cough 4 h Postoperatively | 25 mm | Standard Deviation 19 |
| Normal Saline | Pain Scores During Cough 4 h Postoperatively | 34 mm | Standard Deviation 23 |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine 0.75 | Pain Scores During Cough 8 h Postoperatively | 29 mm | Standard Deviation 25 |
| Normal Saline | Pain Scores During Cough 8 h Postoperatively | 34 mm | Standard Deviation 24 |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine 0.75 | Pain Scores During Cough in the PACU | 42 mm | Standard Deviation 27 |
| Normal Saline | Pain Scores During Cough in the PACU | 55 mm | Standard Deviation 24 |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine 0.75 | Pain Scores in the Postoperative Care Unit (PACU) at Rest | 36 mm | Standard Deviation 25 |
| Normal Saline | Pain Scores in the Postoperative Care Unit (PACU) at Rest | 46 mm | Standard Deviation 21 |