A Comparison Between Continuous and Intermittent Intraabdominal Analgesia Using Local Anaesthetics

NCT ID: NCT01492075

Last Updated: 2015-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-06-30

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.

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.

Conditions

Abdominal Hysterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Continuous infusion

Continuous infusion of LA intraabdominally

Group Type: ACTIVE_COMPARATOR

PCRA (Intermittent injection)

Intervention Type: DRUG

Intermittent injection of LA intraabdominally

PCRA (Intermittent injection)

Patient controlled LA intraabdominally

Group Type: EXPERIMENTAL

PCRA (Intermittent injection)

Intervention Type: DRUG

Intermittent injection of LA intraabdominally

Interventions

PCRA (Intermittent injection)

Intermittent injection of LA intraabdominally

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Anil Gupta

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Perniola, MD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Anil Gupta, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

University Hospital

Örebro, , Sweden

Countries

Sweden

Other Identifiers

20100101

Identifier Type: -

Identifier Source: org_study_id