Local Infiltration Analgesia After Abdominal Hysterectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Local Infiltration Analgesia After Abdominal Hysterectomy

Conditions
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Pain

Intervention / Treatment
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* Drug: ropivacaine, ketorelac and epinephrine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group P<br>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<br>* Placebo group<br>* Other names: Saline;|
| Active Comparator: Group A<br>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<br>* Active group<br>* Other names: Narop, Toradol and adrenaline;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ropivacaine, Analgesia, Local infiltration analgesia, Pain, relief, Pain, Postoperative, 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