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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anil Gupta, Örebro University, Sweden
ClinicalTrials.gov Identifier:
NCT01492075
First received: October 7, 2011
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Abdominal Hysterectomy
Drug: PCRA (Intermittent injection)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study of Postoperative Pain Management

Resource links provided by NLM:


Further study details as provided by Örebro University, Sweden:

Primary Outcome Measures:
  • Morphine consumption [ Time Frame: 0-24 h ] [ Designated as safety issue: No ]
    Total morphine consumption 0 - 24 h postoperatively


Secondary Outcome Measures:
  • Postoperative pain [ Time Frame: 0 - 48 h postoperatively ] [ Designated as safety issue: No ]
    Post-operative pain assessed on the basis of NRS (Numeric Rating Score).

  • PONV [ Time Frame: 0 - 48 h postoperatively ] [ Designated as safety issue: No ]
    Incidence of nausea and vomiting and anti-emetic requirement

  • Home discharge [ Time Frame: 0-10 days ] [ Designated as safety issue: No ]
    Time to home readiness and time to return to work.


Enrollment: 40
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01492075

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

No publications provided

Responsible Party: Anil Gupta, Associate Professor, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT01492075     History of Changes
Other Study ID Numbers: 20100101
Study First Received: October 7, 2011
Last Updated: December 13, 2011
Health Authority: Regional Ethics Committee, Uppsala, Sweden:

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

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

ClinicalTrials.gov processed this record on October 19, 2014