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Local Anesthesia Versus Saline Serum in Surgical Incision of Colorectal or Hepatic Surgery

Randomised and Double-blind Clinical Trial on Post-operative Analgesic Efficacy in Colorectal Surgery and Hepatic Surgery With Continuous Infusion of Local Anesthesia vs Saline Serum in the Surgical Incision.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01075646
Acronym
CATROP-2007
Enrollment
225
Registered
2010-02-25
Start date
2009-03-31
Completion date
2014-06-30
Last updated
2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications, Postoperative Pain, Surgery

Keywords

postoperative pain, wound infusion, local anesthesia

Brief summary

The purpose of this study is to determine whether a continuous infusion of local anesthesia with a catheter in the surgical wound reduces patient consumption of opiates by 30% in the 48-hour postoperative period following surgery for colorectal neoplasm and hepatic surgery versus the continuous infusion of physiological serum.

Detailed description

Postoperative analgesia in major abdominal surgery is managed with intravenous PCA (patient controlled analgesia) with morphine associated to non-steroidal anti-inflammatories drugs (NSAD) and paracetamol in the first 48 hours of the postoperative phase. With this multimodal approach patients undergoing colorectal surgery have a median pain score on the verbal scale (0-10) of 3 (range 0-8) with a mean of morphine consumption of 54 mg (SD 24 mg) and patients undergoing hepatic surgery have a median pain score of 2(range 0-7) with a mean of morphine consumption of 28 mg (SD 17 mg). Although opiates are very potent analgesics they also produce side effects and numerous studies have demonstrated a significant reduction in morbidity when patients received lower dose of opiates during anesthesia and in postoperative period. Continuous infusion of local anesthetics in the surgical wound has been used for pain control in different types of surgeries. However, controversial reports has been reported in abdominal surgery. We are conducting prospective, randomised and double-blind placebo control trials in two surgical models (colo-rectal oncologic surgery and hepatic resection) using continuous perfusion of ropivacaine 0.38% in the surgical wound versus saline. Anesthetic protocol is the same for all patients. Patients undergoing colo-rectal surgery can be operated either in laparotomy or laparoscopic technique therefore patients are stratified into four groups once surgical closure has begun: * Group A1 ropivacaine and laparotomy * Group A2 ropivacaine and laparoscopy * Group B1 saline and laparotomy * Group B2 saline and laparoscopy In the preanesthesia visit patients who match inclusion criteria are invited to participate in the study and they signed the informed consent. When the patient is in the theatre a nurse not involved in the management of patients opens a closed envelope which indicates the solution to be prepared according to the assigned group. The surgeon inserts a multiperforated catheter at the subfascial level of surgical wound , just below the suture of the muscular fascia (between the peritoneum and the muscular fascia) and after that surgeons finish the subcutaneous plane and the skin. After the closure a bolus of 5 ml (laparoscopy colon surgery)or 10 ml (laparotomy colon and hepatic surgery) of the solution is given through the catheter and subsequently an elastomer filled with ropivacaine or saline is connected. The catheter is fixed to the skin with steri-strip and sterile dressing. During the procedure we administer in a protocol basis the NSAD and thirty minutes before the end of the surgery we administer morphine. In the postoperative period the patient receives a NSAD regime and a PCA morphine treatment. The catheter is withdrawn after 48 hours and also the PCA and the analgesic treatment is with NSAD.

Interventions

DRUGropivacaine

Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h. Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h. Hepatic surgery: 10 ml de ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.

DRUGsaline solution

Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h. Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h. Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h

Sponsors

Hospital Universitari de Bellvitge
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* ASA I-III * Undergoing scheduled colorectal cancer and hepatic surgery * Patients must be able to understand the PCA (the self administration system)

Exclusion criteria

* Background of allergic reaction or contraindication for local anesthesia or non steroid anti-inflammatory drugs. * Patient with epidural catheter or receiving combined analgesia during surgery (age above 80, moderate-severe respiratory dysfunction, patients who prior presented complex postoperative pain management. * Emergency surgery * Patients with risk of hepatic insufficiency (Klatskin's tumor, extended right hepatectomy, right hepatectomy in patients with steatosis, hepatic resection in patients over 70 years of age who have been given chemotherapy). * Inflammatory bowel disease: ulcerative colitis, Crohn's disease. * Major psychiatric condition. * Patients with active drug addiction or on chronic treatment with opiates. * Morbid obesity (BMI \> 35 kg/m2) * Patients with heart disease (myocardiopathy, conduction alterations, antiarrhythmic treatment) and severe liver disease (alteration synthesis, histolysis and or cholestasis). * Patients with kidney failure. * Patients treated with fluvoxamine (antidepressant) and enoxacin (antibiotic) both are potent inhibitors of CYPIA2. * Septic patients * Patients that do not wish to participate.

Design outcomes

Primary

MeasureTime frame
Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System48 hours

Secondary

MeasureTime frameDescription
Intensity of Pain Measured by Verbal Pain Scale.At interval periods during 48 hoursVerbal pain scale is a numeric measure of intensity pain, values range from 0 (no pain) to 10 (excruciating pain), Each patient rate the paín that feel with a number from 0 to 10.
Time Spent Sitting in a Chair, Deambulation, Solid Ingestion.7 Days (from Day 8-15)
Secondary Effects Due to Morphine: Nausea and Vomitingduring 48 hours
Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)During 8-15 days
Contamination of the Catheter (Microbiologist Analysis)at 48 hours

Countries

Spain

Participant flow

Recruitment details

Study recruitment took place at the hospital Universitari de Bellvitge in Barcelona, Spain, from April 2010 to April 2012 in the case of colorrectal surgery. In hepatic surgery the study recruitment took place at the same hospital, from April 2010 to June 2014.

Pre-assignment details

In colorrectal surgery 117 patients were assessed for elegibility. Of these 50 patients were excluded before randomization including 23 with exclusion criteria and 18 with a surgical or organization reason. In hepatic surgery 108 patients were assesed for eligibility, 9 patients were excluded with a surgical reason.

Participants by arm

ArmCount
Ropivacaine Colorectal Surgery
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h. Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h.
33
Saline Solution Colorectal Surgery
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h. Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h.
34
Ropivacaine Hepatic Surgery
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
53
Saline Solution Hepatic Surgery
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
46
Total166

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up4312

Baseline characteristics

CharacteristicSaline Solution Hepatic SurgeryRopivacaine Hepatic SurgerySaline Solution Colorectal SurgeryRopivacaine Colorectal SurgeryTotal
Age, Continuous59.73 years63.62 years64.5 years64 years62.96 years
Anemia
No
44 participants51 participants32 participants30 participants157 participants
Anemia
Yes
2 participants2 participants2 participants3 participants9 participants
Antiplatelet drugs
No
45 participants50 participants30 participants28 participants153 participants
Antiplatelet drugs
Yes
1 participants3 participants4 participants5 participants13 participants
Chronic respiratory insuficiency
No
46 participants52 participants34 participants27 participants159 participants
Chronic respiratory insuficiency
Yes
0 participants1 participants0 participants6 participants7 participants
Diabetes
No
35 participants43 participants27 participants23 participants128 participants
Diabetes
Yes
11 participants10 participants7 participants10 participants38 participants
Duration of surgery263.57 minutes274.26 minutes225 minutes205 minutes241.95 minutes
Hypertension
No
31 participants30 participants17 participants18 participants96 participants
Hypertension
Yes
15 participants23 participants17 participants15 participants70 participants
Myocardial disease
No
44 participants51 participants34 participants32 participants161 participants
Myocardial disease
Yes
2 participants2 participants0 participants1 participants5 participants
Sex: Female, Male
Female
17 Participants14 Participants8 Participants13 Participants52 Participants
Sex: Female, Male
Male
29 Participants39 Participants26 Participants20 Participants114 Participants
Size of incision29.67 cm31.5 cm17.5 cm16.5 cm23.79 cm
Stroke
No
44 participants51 participants33 participants30 participants158 participants
Stroke
Yes
2 participants2 participants1 participants3 participants8 participants
Surgical procedure
Left hemicolectomy
0 participants0 participants15 participants14 participants29 participants
Surgical procedure
mayor hepatectomy
17 participants22 participants0 participants0 participants39 participants
Surgical procedure
minor hepatectomy
29 participants30 participants0 participants0 participants59 participants
Surgical procedure
radiofrequency
0 participants1 participants0 participants0 participants1 participants
Surgical procedure
Rectal resections
0 participants0 participants10 participants11 participants21 participants
Surgical procedure
Right hemicolectomy
0 participants0 participants5 participants7 participants12 participants
Surgical procedure
Total colectomy
0 participants0 participants4 participants1 participants5 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 330 / 340 / 530 / 46
serious
Total, serious adverse events
0 / 330 / 340 / 530 / 46

Outcome results

Primary

Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System

Time frame: 48 hours

ArmMeasureValue (MEDIAN)
Ropivacaine Colorectal SurgeryMg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System23 mg
Saline Solution Colorectal SurgeryMg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System52 mg
Ropivacaine Hepatic SurgeryMg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System24.63 mg
Saline Solution Hepatic SurgeryMg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System26.78 mg
Secondary

Contamination of the Catheter (Microbiologist Analysis)

Time frame: at 48 hours

ArmMeasureGroupValue (NUMBER)
Ropivacaine Colorectal SurgeryContamination of the Catheter (Microbiologist Analysis)Yes6 participants
Ropivacaine Colorectal SurgeryContamination of the Catheter (Microbiologist Analysis)No27 participants
Saline Solution Colorectal SurgeryContamination of the Catheter (Microbiologist Analysis)No30 participants
Saline Solution Colorectal SurgeryContamination of the Catheter (Microbiologist Analysis)Yes4 participants
Ropivacaine Hepatic SurgeryContamination of the Catheter (Microbiologist Analysis)Yes2 participants
Ropivacaine Hepatic SurgeryContamination of the Catheter (Microbiologist Analysis)No51 participants
Saline Solution Hepatic SurgeryContamination of the Catheter (Microbiologist Analysis)Yes2 participants
Saline Solution Hepatic SurgeryContamination of the Catheter (Microbiologist Analysis)No44 participants
Secondary

Intensity of Pain Measured by Verbal Pain Scale.

Verbal pain scale is a numeric measure of intensity pain, values range from 0 (no pain) to 10 (excruciating pain), Each patient rate the paín that feel with a number from 0 to 10.

Time frame: At interval periods during 48 hours

ArmMeasureGroupValue (MEDIAN)
Ropivacaine Colorectal SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 24h after surgery2 units on a scale
Ropivacaine Colorectal SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 6h after surgery2 units on a scale
Ropivacaine Colorectal SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 48h after surgery2 units on a scale
Ropivacaine Colorectal SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 12h after surgery2 units on a scale
Ropivacaine Colorectal SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 0h after surgery1 units on a scale
Saline Solution Colorectal SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 12h after surgery2 units on a scale
Saline Solution Colorectal SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 24h after surgery2 units on a scale
Saline Solution Colorectal SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 48h after surgery2 units on a scale
Saline Solution Colorectal SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 6h after surgery3 units on a scale
Saline Solution Colorectal SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 0h after surgery2.5 units on a scale
Ropivacaine Hepatic SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 12h after surgery1.45 units on a scale
Ropivacaine Hepatic SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 0h after surgery2.75 units on a scale
Ropivacaine Hepatic SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 6h after surgery1.72 units on a scale
Ropivacaine Hepatic SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 24h after surgery1.64 units on a scale
Ropivacaine Hepatic SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 48h after surgery1.62 units on a scale
Saline Solution Hepatic SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 24h after surgery2 units on a scale
Saline Solution Hepatic SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 6h after surgery2.38 units on a scale
Saline Solution Hepatic SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 0h after surgery2.5 units on a scale
Saline Solution Hepatic SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 12h after surgery1.8 units on a scale
Saline Solution Hepatic SurgeryIntensity of Pain Measured by Verbal Pain Scale.Verbal numeric scale 48h after surgery2.14 units on a scale
Secondary

Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)

Time frame: During 8-15 days

ArmMeasureGroupValue (NUMBER)
Ropivacaine Colorectal SurgeryLocal Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)Yes6 participants
Ropivacaine Colorectal SurgeryLocal Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)No27 participants
Saline Solution Colorectal SurgeryLocal Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)No24 participants
Saline Solution Colorectal SurgeryLocal Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)Yes10 participants
Ropivacaine Hepatic SurgeryLocal Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)Yes2 participants
Ropivacaine Hepatic SurgeryLocal Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)No51 participants
Saline Solution Hepatic SurgeryLocal Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)Yes2 participants
Saline Solution Hepatic SurgeryLocal Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)No44 participants
Secondary

Secondary Effects Due to Morphine: Nausea and Vomiting

Time frame: during 48 hours

ArmMeasureGroupValue (NUMBER)
Ropivacaine Colorectal SurgerySecondary Effects Due to Morphine: Nausea and VomitingYes5 participants
Ropivacaine Colorectal SurgerySecondary Effects Due to Morphine: Nausea and VomitingNo28 participants
Saline Solution Colorectal SurgerySecondary Effects Due to Morphine: Nausea and VomitingNo28 participants
Saline Solution Colorectal SurgerySecondary Effects Due to Morphine: Nausea and VomitingYes6 participants
Ropivacaine Hepatic SurgerySecondary Effects Due to Morphine: Nausea and VomitingYes2 participants
Ropivacaine Hepatic SurgerySecondary Effects Due to Morphine: Nausea and VomitingNo51 participants
Saline Solution Hepatic SurgerySecondary Effects Due to Morphine: Nausea and VomitingYes6 participants
Saline Solution Hepatic SurgerySecondary Effects Due to Morphine: Nausea and VomitingNo40 participants
Secondary

Time Spent Sitting in a Chair, Deambulation, Solid Ingestion.

Time frame: 7 Days (from Day 8-15)

ArmMeasureGroupValue (MEDIAN)
Ropivacaine Colorectal SurgeryTime Spent Sitting in a Chair, Deambulation, Solid Ingestion.Sitting in the chair46 hours
Ropivacaine Colorectal SurgeryTime Spent Sitting in a Chair, Deambulation, Solid Ingestion.Solid food intake96 hours
Ropivacaine Colorectal SurgeryTime Spent Sitting in a Chair, Deambulation, Solid Ingestion.Deambulation72 hours
Saline Solution Colorectal SurgeryTime Spent Sitting in a Chair, Deambulation, Solid Ingestion.Sitting in the chair48 hours
Saline Solution Colorectal SurgeryTime Spent Sitting in a Chair, Deambulation, Solid Ingestion.Solid food intake120 hours
Saline Solution Colorectal SurgeryTime Spent Sitting in a Chair, Deambulation, Solid Ingestion.Deambulation72 hours
Ropivacaine Hepatic SurgeryTime Spent Sitting in a Chair, Deambulation, Solid Ingestion.Deambulation81.2 hours
Ropivacaine Hepatic SurgeryTime Spent Sitting in a Chair, Deambulation, Solid Ingestion.Sitting in the chair51.75 hours
Ropivacaine Hepatic SurgeryTime Spent Sitting in a Chair, Deambulation, Solid Ingestion.Solid food intake88 hours
Saline Solution Hepatic SurgeryTime Spent Sitting in a Chair, Deambulation, Solid Ingestion.Sitting in the chair43.2 hours
Saline Solution Hepatic SurgeryTime Spent Sitting in a Chair, Deambulation, Solid Ingestion.Solid food intake79.79 hours
Saline Solution Hepatic SurgeryTime Spent Sitting in a Chair, Deambulation, Solid Ingestion.Deambulation87.37 hours

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026