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The purpose of this study is to determine whether spinal anesthesia combined with intrathecal morphine in abdominal hysterectomy on benign gynecological indications gives better outcome concerning duration of hospital stay and postoperative patient comfort than general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol. |
|
| B | Active Comparator | General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacain | Drug | 5 mg/mL, 4 mL intrathecally as a single dos |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospital Stay. | Duration of hospital stay defined as time from start anesthesia to leaving the hospital | Within 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and Degree of Postoperative Symptoms. | Within 6 months after the surgery | |
| Postoperative Consumption of Analgesics and Antiemetics. | Within 6 months after surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Preben Kjölhede, MD, PhD | Department of Obstetrics and Gynecology, University Hospital, Linköping | Study Chair |
| Lena Nilsson, MD, PhD | Department of Anesthesiology, University Hospital, Linköping | Study Director |
| Ninnie B. Wodlin, MD | Department of Obstetrics and Gynecology, University Hospital, Linköping | Study Director |
| Kenneth Krohn, MD | Department of Ostetrics and Gynecology, Vrinnevi Hospital, Norrköping | Principal Investigator |
| Lars Nordenberg, MD | Department of Anesthesiology, Vrinnevi Hospital, Norrköping | Principal Investigator |
| Mats D. Karlsson, MD | Department of Obstetrics and Gynecology, Ryhov Hospital, Jönköping | Principal Investigator |
| Veronica Annerhagen, MD | Department of Anesthesiology, Ryhov Hospital, Jönköping | Principal Investigator |
| Christina Gunnervik, MD | Department of Obstetrics and Gynecology, Värnamo Hospital | Principal Investigator |
| Magnus Trofast, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eksjö Hospital | Eksjö | 57581 | Sweden | |||
| Ryhov Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Vårdtid, funktionskapacitet och sjukskrivningstider efter hysterektomi. Nationella data från 6503 patienter opererade år 2000 och 2001. Återrapport från Nationella registret för kvalitetsutveckling inom gynekologisk kirurgi (Gynop-registret), SFOG, 2003. | ||
| 12095591 | Background | Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8. | |
| 11222424 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Anesthesia | Spinal anesthesia combined with intrathecal morphine |
| FG001 | General Anesthesia | General anesthesia |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Morphine | Drug | 0.4 mg/mL; 0.5 mL intrathecally as a single dosage |
|
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| Propofol | Drug | 2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery |
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| Propofol | Drug | Induction of anesthesia with 1-2 mg/kg body weight IV (intravenously). After intubation maintenance dosage of 6-10 mg/kg/hour IV during the surgery |
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| Fentanyl | Drug | 100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery. |
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| Rocuronbromid | Drug | 0.6 mg/kg body weight IV (intravenously) at induction of anesthesia. If additional muscle relaxation is needed during surgery 5-10 mg is injected IV. The drug is given only at induction of anesthesia and during surgery |
|
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| Morphine | Drug | 5 mg is given IV (intravenously) before end of surgery |
|
|
| Complications and Complication Rates. |
| Within 6 months after the surgery |
| Quality of Life and QALYs (Quality Adjusted Life Years). | Within 6 months after the surgery |
| Sick Leave. | Within 6 months after the surgery |
| The Stress Coping Ability Impact on Postoperative Symptoms and Recovery. | Within 6 months after the surgery |
| Health-related Economy. | Within 6 months after the surgery |
| Department of Anesthesiology, Värnamo Hospital |
| Principal Investigator |
| Tomasz Stypa, MD | Department of Obstetrics and Gynecology, Eksjö Hospital | Principal Investigator |
| Albert Sundberg, MD, PhD | Department of Anesthesiology, Eksjö Hospital | Principal Investigator |
| Jönköping |
| 55185 |
| Sweden |
| University Hospital | Linköping | 58185 | Sweden |
| Vrinnevi Hospital | Norrköping | 60182 | Sweden |
| Värnamo Hospital | Värnamo | 33185 | Sweden |
| Background |
| Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available. |
| 11516794 | Background | Moller C, Kehlet H, Friland SG, Schouenborg LO, Lund C, Ottesen B. Fast track hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2001 Sep;98(1):18-22. doi: 10.1016/s0301-2115(01)00342-6. |
| 16956334 | Background | Persson P, Wijma K, Hammar M, Kjolhede P. Psychological wellbeing after laparoscopic and abdominal hysterectomy--a randomised controlled multicentre study. BJOG. 2006 Sep;113(9):1023-30. doi: 10.1111/j.1471-0528.2006.01025.x. |
| 12911451 | Background | Ellstrom MA, Astrom M, Moller A, Olsson JH, Hahlin M. A randomized trial comparing changes in psychological well-being and sexuality after laparoscopic and abdominal hysterectomy. Acta Obstet Gynecol Scand. 2003 Sep;82(9):871-5. doi: 10.1080/j.1600-0412.2003.00216.x. |
| 22893770 | Derived | Kjolhede P, Langstrom P, Nilsson P, Wodlin NB, Nilsson L. The impact of quality of sleep on recovery from fast-track abdominal hysterectomy. J Clin Sleep Med. 2012 Aug 15;8(4):395-402. doi: 10.5664/jcsm.2032. |
| 22568450 | Derived | Kjolhede P, Borendal Wodlin N, Nilsson L, Fredrikson M, Wijma K. Impact of stress coping capacity on recovery from abdominal hysterectomy in a fast-track programme: a prospective longitudinal study. BJOG. 2012 Jul;119(8):998-1006; discussion 1006-7. doi: 10.1111/j.1471-0528.2012.03342.x. Epub 2012 May 9. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Spinal Anesthesia | Spinal anesthesia combined with intrathecal morphine |
| BG001 | General Anesthesia | General anesthesia |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Hospital Stay. | Duration of hospital stay defined as time from start anesthesia to leaving the hospital | Participants who completed the study were analyzed | Posted | Median | Full Range | Hours | Within 6 months after surgery |
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| Secondary | Occurrence and Degree of Postoperative Symptoms. | Not Posted | Within 6 months after the surgery | ||||||||||||||||||||||||||||||||||||
| Secondary | Postoperative Consumption of Analgesics and Antiemetics. | Not Posted | Within 6 months after surgery | ||||||||||||||||||||||||||||||||||||
| Secondary | Complications and Complication Rates. | Not Posted | Within 6 months after the surgery | ||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life and QALYs (Quality Adjusted Life Years). | Not Posted | Within 6 months after the surgery | ||||||||||||||||||||||||||||||||||||
| Secondary | Sick Leave. | Not Posted | Within 6 months after the surgery | ||||||||||||||||||||||||||||||||||||
| Secondary | The Stress Coping Ability Impact on Postoperative Symptoms and Recovery. | Not Posted | Within 6 months after the surgery | ||||||||||||||||||||||||||||||||||||
| Secondary | Health-related Economy. | Not Posted | Within 6 months after the surgery |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spinal Anesthesia | Spinal anesthesia combined with intrathecal morphine | 7 | 91 | 17 | 91 | ||
| EG001 | General Anesthesia | General anesthesia | 10 | 89 | 16 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary bladder injury | Injury, poisoning and procedural complications |
| |||
| Infections | Infections and infestations |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal wound complication | General disorders |
| |||
| Lower urinary tract infection | Renal and urinary disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Preben Kjolhede | Deptartment of Obstetrics and Gynecology, University Hospital, Linköping, Sweden | +46101030000 | 3187 | Preben.Kjolhede@lio.se |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D009020 | Morphine |
| D015742 | Propofol |
| D005283 | Fentanyl |
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| >=65 years |
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| Male |
|