A Comparison Between Continuous and Intermittent Intraabdominal Analgesia Using Local Anaesthetics

Abdominal Hysterectomy Clinical Trial

— PoPuLAR  

Official title:

Phase IV Study of Postoperative Pain Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492075
• Other study ID #: 20100101
• Status: Completed
• Phase: Phase 4
• First received: October 7, 2011
• Last updated: September 26, 2015
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: September 2015
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Hysterectomy

Intervention

Drug:
• PCRA (Intermittent injection)
Intermittent injection of LA intraabdominally

Locations

Country	Name	City	State
Sweden	University Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	Total morphine consumption 0 - 24 h postoperatively	0-24 h	No
Secondary	Postoperative pain	Post-operative pain assessed on the basis of NRS (Numeric Rating Score).	0 - 48 h postoperatively	No
Secondary	PONV	Incidence of nausea and vomiting and anti-emetic requirement	0 - 48 h postoperatively	No
Secondary	Home discharge	Time to home readiness and time to return to work.	0-10 days	No