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Completed

NCT Number: NCT01492075

A Comparison Between Continuous and Intermittent Intraabdominal Analgesia Using Local Anaesthetics

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital

Örebro, 701 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

PCRA (Intermittent injection)

Drug

Intermittent injection of LA intraabdominally

Primary outcomes

  1. Morphine consumption

    Time frame: 0-24 h

    Total morphine consumption 0 - 24 h postoperatively

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Registry information

Official study title

Phase IV Study of Postoperative Pain Management

Acronym: PoPuLAR

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 14, 2011
Registry last updated
Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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