A Comparison Between Continuous and Intermittent Intraabdominal Analgesia Using Local Anaesthetics (PoPuLAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01492075
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : September 29, 2015
Information provided by (Responsible Party):
Anil Gupta, Örebro University, Sweden

Brief Summary:
The investigators hypothesis is that patient controlled local anesthetics administered intraabdominally are more efficacious compared to continuous infusion in reducing postoperative pain and morphine consumption.

Condition or disease Intervention/treatment Phase
Abdominal Hysterectomy Drug: PCRA (Intermittent injection) Phase 4

Detailed Description:

Open abdominal hysterectomy is a common procedure performed for many benign and malignant gynaecological diseases and is associated with moderate to severe pain. Traditional methods for postoperative pain management include patient controlled intravenous analgesia (PCA) using morphine, epidural analgesia and spinal analgesia with opiates but recently, even local aesthetic (LA) has been used intra-abdominally and into the abdominal wall. Although epidural analgesia may be considered by some to be gold standard for pain relief following abdominal surgery, a recent publication and past experience over several years may question the use of invasive techniques for lower abdominal surgery. Thus, there is a trend towards movement from central blocks towards other non-invasive methods for pain relief.

PCA with morphine is now commonly used for management of pain following major surgery and compared to central blocks, has advantages in being relatively safe, easy to use and associated with a high degree of patient satisfaction. However, the large doses of morphine necessary to ensure adequate postoperative analgesia means that side effects such as postoperative nausea and vomiting (PONV), tiredness, pruritus, headache and constipation may be a major problem in this group of patients. Therefore, alternative techniques to reduce morphine requirements are increasingly being used. These include the use of paracetamol, non-steroidal anti-inflammatory drugs (NSAID) and recently local anaesthetics (LA). The latter have been found to result in morphine sparing by 30 - 40 % and even a reduction in postoperative nausea (PON). LA infused intraperitoneally is safe and effective and a recent study showed that using 12.5 mg/h levobupivacaine could attain adequate analgesia. Thus, efficacy of LA has been established as well as the dose. However, the method of administration of LA intraperitoneally remains unclear.

This study is designed with the primary aim of studying whether morphine consumption can be reduced postoperatively using the patient-controlled administration system for intraperitoneal LA compared to a continuous infusion, and whether this translates into improved recovery parameters or reduced side effects and improved patient satisfaction.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study of Postoperative Pain Management
Study Start Date : January 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Active Comparator: Continuous infusion
Continuous infusion of LA intraabdominally
Drug: PCRA (Intermittent injection)
Intermittent injection of LA intraabdominally

Experimental: PCRA (Intermittent injection)
Patient controlled LA intraabdominally
Drug: PCRA (Intermittent injection)
Intermittent injection of LA intraabdominally

Primary Outcome Measures :
  1. Morphine consumption [ Time Frame: 0-24 h ]
    Total morphine consumption 0 - 24 h postoperatively

Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: 0 - 48 h postoperatively ]
    Post-operative pain assessed on the basis of NRS (Numeric Rating Score).

  2. PONV [ Time Frame: 0 - 48 h postoperatively ]
    Incidence of nausea and vomiting and anti-emetic requirement

  3. Home discharge [ Time Frame: 0-10 days ]
    Time to home readiness and time to return to work.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 18 -65 year old patients undergoing open abdominal hysterectomy.
  2. ASA I - II (Appendix 1).
  3. Have signed and dated Informed Consent.
  4. Willing and able to comply with the protocol for the duration of the trial.

Exclusion Criteria:

  1. Patients undergoing open abdominal hysterectomy due to suspected cancer.
  2. Patients with chronic pain who are taking analgesics regularly.
  3. Allergy to components in levobupivacaine (Chirocaine)/Saline (Sodium Chloride).
  4. Participation in other clinical trials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01492075

University Hospital
Örebro, Sweden, 701 85
Sponsors and Collaborators
Örebro University, Sweden
Principal Investigator: Andrea Perniola, MD Örebro University
Principal Investigator: Anil Gupta, PhD Örebro University

Responsible Party: Anil Gupta, Associate Professor, Örebro University, Sweden Identifier: NCT01492075     History of Changes
Other Study ID Numbers: 20100101
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015

Keywords provided by Anil Gupta, Örebro University, Sweden:
Postoperative pain
Anesthetics: Local anesthetics
Surgery: Hysterectomy

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents