Local Infiltration Analgesia After Abdominal Hysterectomy (LIA)

January 19, 2015 updated by: Göteborg University
The aim of the study is to evaluate traditional analgesic therapy after abdominal hysterectomy with single infiltration of local anesthetics in the surgical area at the end of surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a controlled, double blind, prospective, randomized and performed at Sahlgrenska University Hospital in Goteborg, Sweden. The injectant mixture consists of 300 mg ropivacaine mixed with 30 mg ketorolac and 0.5 mg epinephrine. Total volume of the solution is 156 ml. The normal saline injection is used in the control group in the same manner as in the LIA group. The parameters which would be evaluated are consumption of morphine, pain intensity and side effects.

The primary objective is to evaluate whether local infiltration analgesia (LIA) into the operating field will reduce morphine consumption during the first 24 postoperative hours in patients undergoing abdominal hysterectomy (AH).

Secondary end-points are pain intensity, incidence of nausea and vomiting, sedation intensity.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Goteborg, Sweden, SE41385
        • Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients requiring abdominal hysterectomy

Exclusion Criteria:

  • Body mass index > 35
  • American Society of Anesthesiologists classification > 3
  • Renal dysfunction
  • Allergic to acetylsalicylic acid
  • Unwilling to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group P

Group P (Placebo) receives a local infiltration of saline in the operating field and ketorolac iv.

In Group P the injectant consists of saline, total volume 156 mL. This is infiltrated by the surgeon into the soft tissue of the vagina, tubosacral and rotundum ligaments, in the abdominal fascia and subcutaneous at the end of surgery. Ketorolac 30 mg (1 mL) is also injected iv.
Drug: Placebo
Placebo group
Other Names:
  • Saline
Active Comparator: Group A

Group A (Active) receives a local infiltration of ropivacaine, ketorolac and epinephrine in the operating field and saline iv.

Drug: ropivacaine, ketorelac and epinephrine

In Group A the injectant mixture consists of ropivacaine 300 mg mixed with 30 mg ketorolac and 0.5 mg epinephrine, total volume 156 mL. This mixture is infiltrated by the surgeon into the soft tissue of the vagina, tubosacral and rotundum ligaments, in the abdominal fascia and subcutaneous at the end of surgery. One mL saline is also injected iv.
Drug: ropivacaine, ketorelac and epinephrine
Active group
Other Names:
  • Narop, Toradol and adrenaline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total morphine consumption
Time Frame: 0-24 hours postoperatively
0-24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain intensity (NRS, Numeric Rating Score 0-10)
Time Frame: 0-24 hours postoperatively
0-24 hours postoperatively
Incidence of nausea and vomiting
Time Frame: 0-24 hours postoperatively
0-24 hours postoperatively
Sedation intensity (Ramsey scale)
Time Frame: 0-24 hours postoperatively
0-24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Principal Investigator: Sven-Egron Thorn, MD, PhD, Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
  • Study Chair: Anil Gupta, MD, PhD, Dept. of Anesthesia and Intensive Care, Orebro University Hospital, Orebro, Sweden
  • Study Chair: Ove Carlsson, MD, Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
  • Study Chair: Karin Olausson, MD, Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
  • Study Chair: Olof Eckre, MD, PhD, Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
  • Study Chair: Sven-Erik Ricksten, MD,PhD, Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
  • Study Chair: Fatma Backman, MD, Dept. of Gynecological Surgery, Orebro University Hospital, Orebro, Sweden
  • Study Chair: Elisabeth Stadberg, MD, Dept. of Gynecological Surgery, Sahlgrenska University Hospital, Goteborg, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

February 1, 2013

First Posted (Estimate)

February 4, 2013

Study Record Updates

Last Update Posted (Estimate)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIA-AH-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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