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Completed

NCT Number: NCT01782781

Local Infiltration Analgesia After Abdominal Hysterectomy

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.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital

Gothenburg, SE41385, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ropivacaine, ketorelac and epinephrine

Drug

Active group

Other names: Narop, Toradol and adrenaline

Placebo

Drug

Placebo group

Other names: Saline

Primary outcomes

  1. Total morphine consumption

    Time frame: 0-24 hours postoperatively

Secondary outcomes

  1. Pain intensity (NRS, Numeric Rating Score 0-10)

    Time frame: 0-24 hours postoperatively

  2. Incidence of nausea and vomiting

    Time frame: 0-24 hours postoperatively

  3. Sedation intensity (Ramsey scale)

    Time frame: 0-24 hours postoperatively

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Acronym: LIA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2013
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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