Local Infiltration Analgesia After Abdominal Hysterectomy (LIA)
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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 |
- Total morphine consumption [ Time Frame: 0-24 hours postoperatively ] [ Designated as safety issue: Yes ]
- 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: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (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 |
|
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 |
Inclusion Criteria:
- Patients requiring abdominal hysterectomy
Exclusion Criteria:
- BMI > 35
- ASA > 3
- Renal dysfunction
- Allergic to ASA
- Unwilling to provide informed consent
Contacts and Locations| Contact: Sven-Egron Thorn, MD PhD | +46313434903 | sven-egron.thorn@vgregion.se |
| Contact: Jane Hayden, MD | +46313430716 | jane.hayden@vgregion.se |
| 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 | |
| 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: | February 1, 2013 |
| 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:
|
Epinephrine Epinephryl borate Ropivacaine Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Physiological Effects of Drugs Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Mydriatics Adrenergic alpha-Agonists Sympathomimetics Vasoconstrictor Agents Cardiovascular Agents Analgesics Sensory System Agents Antirheumatic Agents Anesthetics, Local Anesthetics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 22, 2013