Local Anesthesia Versus Saline Serum in Surgical Incision of Colorectal or Hepatic Surgery (CATROP-2007)

• ClinicalTrials.gov Identifier: NCT01075646
• Recruitment Status: Completed
• First Posted: February 25, 2010
• Results First Posted: November 18, 2016
• Last Update Posted: March 27, 2017
• Sponsor: Hospital Universitari de Bellvitge
• Information provided by (Responsible Party): antonia dalmau llitjos, Hospital Universitari de Bellvitge

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain; Surgery; Postoperative Complications	Drug: ropivacaine; Drug: saline solution	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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.
• Study Start Date: March 2009
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ropivacaine; After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours	Drug: 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. 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	Drug: saline 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; Other Name: wound infusion saline solution

Outcome Measures

Primary Outcome Measures :

1. Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System [ Time Frame: 48 hours ]

Secondary Outcome Measures :

1. Intensity of Pain Measured by Verbal Pain Scale. [ Time Frame: 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.
2. Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. [ Time Frame: 7 Days (from Day 8-15) ]
3. Secondary Effects Due to Morphine: Nausea and Vomiting [ Time Frame: during 48 hours ]
4. Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection) [ Time Frame: During 8-15 days ]
5. Contamination of the Catheter (Microbiologist Analysis) [ Time Frame: at 48 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Spain

Anesthesiology Service of Univeritary Hospital of Bellvitge

Hospitalet . Barcelona, Barcelona, Spain, 08907

Sponsors and Collaborators

Hospital Universitari de Bellvitge

Investigators

• Study Director: Antònia Dalmau Llitjós, Physical D; Univeritary Hospital of Bellvitge. IDIBELL

More Information

Publications:

Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg. 2006 Dec;203(6):914-32. Epub 2006 Oct 25. Review.

Beaussier M, El'Ayoubi H, Schiffer E, Rollin M, Parc Y, Mazoit JX, Azizi L, Gervaz P, Rohr S, Biermann C, Lienhart A, Eledjam JJ. Continuous preperitoneal infusion of ropivacaine provides effective analgesia and accelerates recovery after colorectal surgery: a randomized, double-blind, placebo-controlled study. Anesthesiology. 2007 Sep;107(3):461-8.

Wu CL, Partin AW, Rowlingson AJ, Kalish MA, Walsh PC, Fleisher LA. Efficacy of continuous local anesthetic infusion for postoperative pain after radical retropubic prostatectomy. Urology. 2005 Aug;66(2):366-70.

Gupta A, Perniola A, Axelsson K, Thörn SE, Crafoord K, Rawal N. Postoperative pain after abdominal hysterectomy: a double-blind comparison between placebo and local anesthetic infused intraperitoneally. Anesth Analg. 2004 Oct;99(4):1173-9, table of contents.

Zohar E, Fredman B, Phillipov A, Jedeikin R, Shapiro A. The analgesic efficacy of patient-controlled bupivacaine wound instillation after total abdominal hysterectomy with bilateral salpingo-oophorectomy. Anesth Analg. 2001 Aug;93(2):482-7, 4th contents page.

Fredman B, Zohar E, Tarabykin A, Shapiro A, Mayo A, Klein E, Jedeikin R. Bupivacaine wound instillation via an electronic patient-controlled analgesia device and a double-catheter system does not decrease postoperative pain or opioid requirements after major abdominal surgery. Anesth Analg. 2001 Jan;92(1):189-93.

Chester JF, Ravindranath K, White BD, Shanahan D, Taylor RS, Lloyd-Williams K. Wound perfusion with bupivacaine: objective evidence for efficacy in postoperative pain relief. Ann R Coll Surg Engl. 1989 Nov;71(6):394-6.

Baig MK, Zmora O, Derdemezi J, Weiss EG, Nogueras JJ, Wexner SD. Use of the ON-Q pain management system is associated with decreased postoperative analgesic requirement: double blind randomized placebo pilot study. J Am Coll Surg. 2006 Feb;202(2):297-305.

• Responsible Party: antonia dalmau llitjos, MD PhD, Hospital Universitari de Bellvitge
• ClinicalTrials.gov Identifier: NCT01075646
• Other Study ID Numbers: ANESTHESIA SERVICE HUB
• First Posted: February 25, 2010
• Results First Posted: November 18, 2016
• Last Update Posted: March 27, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by antonia dalmau llitjos, Hospital Universitari de Bellvitge:

postoperative pain; wound infusion; local anesthesia

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Surgical Wound; Pathologic Processes; Pain; Neurologic Manifestations; Wounds and Injuries; Ropivacaine; Pharmaceutical Solutions; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents