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

Phase IV Study of Postoperative Pain Management

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Hysterectomy
• Intervention / Treatment: Drug: PCRA (Intermittent injection)

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
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 701 85
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption	Total morphine consumption 0 - 24 h postoperatively	0-24 h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Post-operative pain assessed on the basis of NRS (Numeric Rating Score).	0 - 48 h postoperatively
PONV	Incidence of nausea and vomiting and anti-emetic requirement	0 - 48 h postoperatively
Home discharge	Time to home readiness and time to return to work.	0-10 days

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Investigators: Principal Investigator: Andrea Perniola, MD, Örebro University, Sweden; Principal Investigator: Anil Gupta, PhD, Örebro University, Sweden

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: October 7, 2011
• First Submitted That Met QC Criteria: December 13, 2011
• First Posted (Estimate): December 14, 2011

Study Record Updates

• Last Update Posted (Estimate): September 29, 2015
• Last Update Submitted That Met QC Criteria: September 26, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Postoperative pain; Anesthetics: Local anesthetics; Surgery: Hysterectomy
• Other Study ID Numbers: 20100101 (Helse Sorost)