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

Postoperative Pain Clinical Trial

— CATROP-2007  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075646
• Other study ID #: ANESTHESIA SERVICE HUB
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2010
• Last updated: March 17, 2015
• Start date: March 2009
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Major Abdominal Surgery
• Pain, Postoperative
• Postoperative Outcome
• Postoperative Pain

Intervention

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.
• 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. Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h

Locations

Country	Name	City	State
Spain	Anesthesiology Service of Univeritary Hospital of Bellvitge	Hospitalet . Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mg of morphine consumption during 48 hours administered by patient controlled analgesia system		48 hours	No
Secondary	Intensity of pain measured by verbal pain scale.		At interval periods during 48 hours	No
Secondary	Sitting in a chair, Deambulation, solid ingestion.		8-15 days	No
Secondary	secondary effects due to morphine: nausea and vomiting, itching, sedation and respiratory depression.		during 48 hours	Yes
Secondary	Local reaction in the wound and insertion point of the catheter (inflammation signs and infection)		During 8-15 days	Yes
Secondary	contamination of the catheter (microbiologist analysis)		at 48 hours	Yes