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Continuous Intraperitoneal Infusion of Local Anesthetics vs. Patient Controlled Intraperitoneal injection for Postoperative Pain relief following Abdominal Hysterectomy. A randomized, double-blind study

Continuous Intraperitoneal Infusion of Local Anesthetics vs. Patient Controlled Intraperitoneal injection for Postoperative Pain relief following Abdominal Hysterectomy. A randomized, double-blind study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-003737-33-SE
Enrollment
Unknown
Registered
2006-09-07
Start date
2006-10-05
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain after open abdominal hysterectomy

Interventions

Trade Name: Chirocaine Pharmaceutical Form: Solution for infusion Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 1,25- Pharmaceutical form of the placebo: Solution for infusio

Sponsors

Örebro University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 18 –65 year old patients undergoing open abdominal hysterectomy. ASA I – II Have signed and dated Informed Consent. Willing and able to comply with the protocol for the duration of the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Secondary Objective: Can efficient post-operative pain improved patient "outcome" following abdominal hysterectomy?;Primary end point(s): Total morphine consumption 0 – 24 h postoperatively.;Main Objective: Which method for administration of intraperitoneal local anesthetics gives the best pain relief and requires the lowest morphine consumption after abdominal hysterectomy, patient controlled administration (PCA) or continuous infusion.

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026