Local Infiltration Analgesia After Abdominal Hysterectomy (LIA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Göteborg University
Sponsor:
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01782781
First received: January 7, 2013
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Pain
Drug: ropivacaine, ketorelac and epinephrine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Local Infiltration Analgesia After Abdominal Hysterectomy

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Total morphine consumption [ Time Frame: 0-24 hours postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain intensity (NRS, Numeric Rating Score 0-10) [ Time Frame: 0-24 hours postoperatively ] [ Designated as safety issue: Yes ]
  • Incidence of nausea and vomiting [ Time Frame: 0-24 hours postoperatively ] [ Designated as safety issue: Yes ]
  • Sedation intensity (Ramsey scale) [ Time Frame: 0-24 hours postoperatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Narop, Toradol and adrenaline

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782781

Contacts
Contact: Sven-Egron Thorn, MD PhD +46313434903 sven-egron.thorn@vgregion.se
Contact: Jane Hayden, MD +46313430716 jane.hayden@vgregion.se

Locations
Sweden
Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital Recruiting
Goteborg, Sweden, SE41385
Contact: Sven-Egron Thorn, MD, PhD    +46313434903    sven-egron@vgregion.se   
Contact: Jane Hayden, MD    +46313430716    jane.haydenvg@region.se   
Principal Investigator: Sven-Egron Thorn, MD, PhD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01782781     History of Changes
Other Study ID Numbers: LIA-AH-1
Study First Received: January 7, 2013
Last Updated: October 1, 2014
Health Authority: Sweden: Swedish Data Inspection Board
Sweden: The National Board of Health and Welfare

Keywords provided by Göteborg University:
Analgesia
Local infiltration analgesia
Pain, relief
Pain, Postoperative
Ropivacaine
Ketorolac
Epinephrine
Adrenergic Agonists
Sympathomimetics
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Opioids
Morphine
Pain
Postoperative Complications
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Epinephrine
Epinephryl borate
Racepinephrine
Ropivacaine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, Local
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Sympathomimetics

ClinicalTrials.gov processed this record on October 22, 2014