Postoperative Complications, Postoperative Pain, Surgery
Conditions
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
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.
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
Study design
Eligibility
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
| Measure | Time frame |
|---|---|
| Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System | 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of Pain Measured by Verbal Pain Scale. | At interval periods during 48 hours | 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 Spent Sitting in a Chair, Deambulation, Solid Ingestion. | 7 Days (from Day 8-15) | — |
| Secondary Effects Due to Morphine: Nausea and Vomiting | during 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
| Arm | Count |
|---|---|
| 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 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 3 | 1 | 2 |
Baseline characteristics
| Characteristic | Saline Solution Hepatic Surgery | Ropivacaine Hepatic Surgery | Saline Solution Colorectal Surgery | Ropivacaine Colorectal Surgery | Total |
|---|---|---|---|---|---|
| Age, Continuous | 59.73 years | 63.62 years | 64.5 years | 64 years | 62.96 years |
| Anemia No | 44 participants | 51 participants | 32 participants | 30 participants | 157 participants |
| Anemia Yes | 2 participants | 2 participants | 2 participants | 3 participants | 9 participants |
| Antiplatelet drugs No | 45 participants | 50 participants | 30 participants | 28 participants | 153 participants |
| Antiplatelet drugs Yes | 1 participants | 3 participants | 4 participants | 5 participants | 13 participants |
| Chronic respiratory insuficiency No | 46 participants | 52 participants | 34 participants | 27 participants | 159 participants |
| Chronic respiratory insuficiency Yes | 0 participants | 1 participants | 0 participants | 6 participants | 7 participants |
| Diabetes No | 35 participants | 43 participants | 27 participants | 23 participants | 128 participants |
| Diabetes Yes | 11 participants | 10 participants | 7 participants | 10 participants | 38 participants |
| Duration of surgery | 263.57 minutes | 274.26 minutes | 225 minutes | 205 minutes | 241.95 minutes |
| Hypertension No | 31 participants | 30 participants | 17 participants | 18 participants | 96 participants |
| Hypertension Yes | 15 participants | 23 participants | 17 participants | 15 participants | 70 participants |
| Myocardial disease No | 44 participants | 51 participants | 34 participants | 32 participants | 161 participants |
| Myocardial disease Yes | 2 participants | 2 participants | 0 participants | 1 participants | 5 participants |
| Sex: Female, Male Female | 17 Participants | 14 Participants | 8 Participants | 13 Participants | 52 Participants |
| Sex: Female, Male Male | 29 Participants | 39 Participants | 26 Participants | 20 Participants | 114 Participants |
| Size of incision | 29.67 cm | 31.5 cm | 17.5 cm | 16.5 cm | 23.79 cm |
| Stroke No | 44 participants | 51 participants | 33 participants | 30 participants | 158 participants |
| Stroke Yes | 2 participants | 2 participants | 1 participants | 3 participants | 8 participants |
| Surgical procedure Left hemicolectomy | 0 participants | 0 participants | 15 participants | 14 participants | 29 participants |
| Surgical procedure mayor hepatectomy | 17 participants | 22 participants | 0 participants | 0 participants | 39 participants |
| Surgical procedure minor hepatectomy | 29 participants | 30 participants | 0 participants | 0 participants | 59 participants |
| Surgical procedure radiofrequency | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Surgical procedure Rectal resections | 0 participants | 0 participants | 10 participants | 11 participants | 21 participants |
| Surgical procedure Right hemicolectomy | 0 participants | 0 participants | 5 participants | 7 participants | 12 participants |
| Surgical procedure Total colectomy | 0 participants | 0 participants | 4 participants | 1 participants | 5 participants |
Adverse events
| Event type | EG000 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 / 33 | 0 / 34 | 0 / 53 | 0 / 46 |
| serious Total, serious adverse events | 0 / 33 | 0 / 34 | 0 / 53 | 0 / 46 |
Outcome results
Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ropivacaine Colorectal Surgery | Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System | 23 mg |
| Saline Solution Colorectal Surgery | Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System | 52 mg |
| Ropivacaine Hepatic Surgery | Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System | 24.63 mg |
| Saline Solution Hepatic Surgery | Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System | 26.78 mg |
Contamination of the Catheter (Microbiologist Analysis)
Time frame: at 48 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropivacaine Colorectal Surgery | Contamination of the Catheter (Microbiologist Analysis) | Yes | 6 participants |
| Ropivacaine Colorectal Surgery | Contamination of the Catheter (Microbiologist Analysis) | No | 27 participants |
| Saline Solution Colorectal Surgery | Contamination of the Catheter (Microbiologist Analysis) | No | 30 participants |
| Saline Solution Colorectal Surgery | Contamination of the Catheter (Microbiologist Analysis) | Yes | 4 participants |
| Ropivacaine Hepatic Surgery | Contamination of the Catheter (Microbiologist Analysis) | Yes | 2 participants |
| Ropivacaine Hepatic Surgery | Contamination of the Catheter (Microbiologist Analysis) | No | 51 participants |
| Saline Solution Hepatic Surgery | Contamination of the Catheter (Microbiologist Analysis) | Yes | 2 participants |
| Saline Solution Hepatic Surgery | Contamination of the Catheter (Microbiologist Analysis) | No | 44 participants |
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ropivacaine Colorectal Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 24h after surgery | 2 units on a scale |
| Ropivacaine Colorectal Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 6h after surgery | 2 units on a scale |
| Ropivacaine Colorectal Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 48h after surgery | 2 units on a scale |
| Ropivacaine Colorectal Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 12h after surgery | 2 units on a scale |
| Ropivacaine Colorectal Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 0h after surgery | 1 units on a scale |
| Saline Solution Colorectal Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 12h after surgery | 2 units on a scale |
| Saline Solution Colorectal Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 24h after surgery | 2 units on a scale |
| Saline Solution Colorectal Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 48h after surgery | 2 units on a scale |
| Saline Solution Colorectal Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 6h after surgery | 3 units on a scale |
| Saline Solution Colorectal Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 0h after surgery | 2.5 units on a scale |
| Ropivacaine Hepatic Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 12h after surgery | 1.45 units on a scale |
| Ropivacaine Hepatic Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 0h after surgery | 2.75 units on a scale |
| Ropivacaine Hepatic Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 6h after surgery | 1.72 units on a scale |
| Ropivacaine Hepatic Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 24h after surgery | 1.64 units on a scale |
| Ropivacaine Hepatic Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 48h after surgery | 1.62 units on a scale |
| Saline Solution Hepatic Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 24h after surgery | 2 units on a scale |
| Saline Solution Hepatic Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 6h after surgery | 2.38 units on a scale |
| Saline Solution Hepatic Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 0h after surgery | 2.5 units on a scale |
| Saline Solution Hepatic Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 12h after surgery | 1.8 units on a scale |
| Saline Solution Hepatic Surgery | Intensity of Pain Measured by Verbal Pain Scale. | Verbal numeric scale 48h after surgery | 2.14 units on a scale |
Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)
Time frame: During 8-15 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropivacaine Colorectal Surgery | Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection) | Yes | 6 participants |
| Ropivacaine Colorectal Surgery | Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection) | No | 27 participants |
| Saline Solution Colorectal Surgery | Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection) | No | 24 participants |
| Saline Solution Colorectal Surgery | Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection) | Yes | 10 participants |
| Ropivacaine Hepatic Surgery | Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection) | Yes | 2 participants |
| Ropivacaine Hepatic Surgery | Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection) | No | 51 participants |
| Saline Solution Hepatic Surgery | Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection) | Yes | 2 participants |
| Saline Solution Hepatic Surgery | Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection) | No | 44 participants |
Secondary Effects Due to Morphine: Nausea and Vomiting
Time frame: during 48 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropivacaine Colorectal Surgery | Secondary Effects Due to Morphine: Nausea and Vomiting | Yes | 5 participants |
| Ropivacaine Colorectal Surgery | Secondary Effects Due to Morphine: Nausea and Vomiting | No | 28 participants |
| Saline Solution Colorectal Surgery | Secondary Effects Due to Morphine: Nausea and Vomiting | No | 28 participants |
| Saline Solution Colorectal Surgery | Secondary Effects Due to Morphine: Nausea and Vomiting | Yes | 6 participants |
| Ropivacaine Hepatic Surgery | Secondary Effects Due to Morphine: Nausea and Vomiting | Yes | 2 participants |
| Ropivacaine Hepatic Surgery | Secondary Effects Due to Morphine: Nausea and Vomiting | No | 51 participants |
| Saline Solution Hepatic Surgery | Secondary Effects Due to Morphine: Nausea and Vomiting | Yes | 6 participants |
| Saline Solution Hepatic Surgery | Secondary Effects Due to Morphine: Nausea and Vomiting | No | 40 participants |
Time Spent Sitting in a Chair, Deambulation, Solid Ingestion.
Time frame: 7 Days (from Day 8-15)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ropivacaine Colorectal Surgery | Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. | Sitting in the chair | 46 hours |
| Ropivacaine Colorectal Surgery | Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. | Solid food intake | 96 hours |
| Ropivacaine Colorectal Surgery | Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. | Deambulation | 72 hours |
| Saline Solution Colorectal Surgery | Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. | Sitting in the chair | 48 hours |
| Saline Solution Colorectal Surgery | Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. | Solid food intake | 120 hours |
| Saline Solution Colorectal Surgery | Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. | Deambulation | 72 hours |
| Ropivacaine Hepatic Surgery | Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. | Deambulation | 81.2 hours |
| Ropivacaine Hepatic Surgery | Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. | Sitting in the chair | 51.75 hours |
| Ropivacaine Hepatic Surgery | Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. | Solid food intake | 88 hours |
| Saline Solution Hepatic Surgery | Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. | Sitting in the chair | 43.2 hours |
| Saline Solution Hepatic Surgery | Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. | Solid food intake | 79.79 hours |
| Saline Solution Hepatic Surgery | Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. | Deambulation | 87.37 hours |