Local Anesthesia Versus Saline Serum in Surgical Incision of Colorectal or Hepatic Surgery (CATROP-2007)
Major Abdominal Surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||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.|
- Mg of morphine consumption during 48 hours administered by patient controlled analgesia system [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Intensity of pain measured by verbal pain scale. [ Time Frame: At interval periods during 48 hours ] [ Designated as safety issue: No ]
- Sitting in a chair, Deambulation, solid ingestion. [ Time Frame: 8-15 days ] [ Designated as safety issue: No ]
- secondary effects due to morphine: nausea and vomiting, itching, sedation and respiratory depression. [ Time Frame: during 48 hours ] [ Designated as safety issue: Yes ]
- Local reaction in the wound and insertion point of the catheter (inflammation signs and infection) [ Time Frame: During 8-15 days ] [ Designated as safety issue: Yes ]
- contamination of the catheter (microbiologist analysis) [ Time Frame: at 48 hours ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2009|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
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.
Other Name: (wound infusion ropivacaine)
Placebo Comparator: saline solution
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
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
Other Name: wound infusion saline solution
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075646
|Anesthesiology Service of Univeritary Hospital of Bellvitge|
|Hospitalet . Barcelona, Barcelona, Spain, 08907|
|Study Director:||Antònia Dalmau Llitjós, Physical D||Univeritary Hospital of Bellvitge. IDIBELL|