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

2014-08-27 03:15:37 | BioPortfolio


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.


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. As a alternative analgesia we give metamizol when the patient presents pain score > 3 according to the verbal scale.

The catheter is withdrawn after 48 hours and also the PCA and the analgesic treatment is with NSAD.

Study Design

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


Postoperative Pain


ropivacaine, placebo


Anesthesiology Service of Univeritary Hospital of Bellvitge
Hospitalet . Barcelona


Enrolling by invitation


Hospital Universitari de Bellvitge

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:37-0400

Clinical Trials [3347 Associated Clinical Trials listed on BioPortfolio]

Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients

The purpose of this study is to evaluate the effect of pain relief after infusion of ropivacaine at port sites at end of laparoscopic cholecystectomy (LC)compared with placebo (0.9% normal...

Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % versus Ropivacaine 0.2 % versus Placebo in patients undergoing elective caesarean section. The...

Local Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind Study

The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % vs. Placebo in patients undergoing vaginal hysterectomy. The hypothesis is that systematic loc...

Thoracic Paravertebral Block for Postoperative Analgesia After Video-assisted Thoracic Surgery.

The use of paravertebral catheters is a recommended technique to achieve postoperative analgesia after thoracic surgery. To date there is no consensus on which drug regime (local anestheti...

Choose the Best Concentration of Ropivacaine on TAP Block for Open Appendectomy in Children

Blockage of the transverse abdomen (TAP) promotes excellent analgesia of the abdominal wall and the parietal peritoneum. The TAP block could advange the postoperative pain of Appendectomy ...

PubMed Articles [6493 Associated PubMed Articles listed on BioPortfolio]

Immediate postoperative pain control with ropivacaine following laparoscopic-assisted vaginal hysterectomy: A randomized double-blind pilot study.

Although laparoscopic hysterectomy, a worldwide popular surgery, ensures faster recovery and less postoperative pain than with laparotomic hysterectomy, immediate pain control still improving postoper...

A randomised trial of serratus anterior plane block for analgesia after thoracoscopic surgery.

We evaluated the effect of pre-operative serratus anterior plane block on postoperative pain and opioid consumption after thoracoscopic surgery. We randomly allocated 89 participants to block with 30 ...

The Prolonged Analgesic Efficacy of an Ultrasound-Guided Single-Shot Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty.

In this prospective, randomized, placebo-controlled study, the authors compared the analgesic efficacy of the single-shot adductor canal block (SS-ACB) vs the continuous adductor canal block (C-ACB) w...

Estimating Relative Efficacy in Acute Postoperative Pain: Network Meta-Analysis is Consistent with Indirect Comparison to Placebo Alone.

Network meta-analysis (NMA) uses direct comparisons of interventions within randomized controlled trials and indirect comparisons across them. NMA uses more data than a series of direct comparisons wi...

Placebo Responses in Chronic Pain: State of Research and Clinical Implications.

Placebo hypoalgesia has been found to play an important role in every health care by modulating patients' responses to pharmacologically active analgesic treatments. It may be seen as reflecting the c...

Medical and Biotech [MESH] Definitions

A nonsteroidal anti-inflammatory agent with potent analgesic and antiarthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ankylosing SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).

Pain during the period after surgery.

A narcotic analgesic that can be used for the relief of most types of moderate to severe pain, including postoperative pain and the pain of labor. Prolonged use may lead to dependence of the morphine type; withdrawal symptoms appear more rapidly than with morphine and are of shorter duration.

Abdominal symptoms after removal of the GALLBLADDER. The common postoperative symptoms are often the same as those present before the operation, such as COLIC, bloating, NAUSEA, and VOMITING. There is pain on palpation of the right upper quadrant and sometimes JAUNDICE. The term is often used, inaccurately, to describe such postoperative symptoms not due to gallbladder removal.

Relief of PAIN, without loss of CONSCIOUSNESS, through ANALGESIC AGENTS administered by the patients. It has been used successfully to control POSTOPERATIVE PAIN, during OBSTETRIC LABOR, after BURNS, and in TERMINAL CARE. The choice of agent, dose, and lockout interval greatly influence effectiveness. The potential for overdose can be minimized by combining small bolus doses with a mandatory interval between successive doses (lockout interval).

More From BioPortfolio on "Local Anesthesia Versus Saline Serum in Surgical Incision of Colorectal or Hepatic Surgery"

Quick Search


Relevant Topics

An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Wound management
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...

Searches Linking to this Trial