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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group P | Placebo Comparator | 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. |
|
| Group A | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivacaine, ketorelac and epinephrine | Drug | Active group |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine consumption | 0-24 hours postoperatively |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sven-Egron Thorn, MD, PhD | Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden | Principal Investigator |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital | Gothenburg | SE41385 | Sweden |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| D020911 | Ketorolac Tromethamine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo | Drug | Placebo group |
|
|
| 0-24 hours postoperatively |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |