Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy
NCT ID: NCT00527332
Last Updated: 2012-01-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
180 participants
INTERVENTIONAL
2007-03-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy.
NCT04675840
Optimal Multimodal Analgesia in Abdominal Hysterectomy
NCT00209872
Randomized Controlled Trial Comparing Postoperative Pain Following TAH With GA vs. Combined GA + SAB
NCT01511627
Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients
NCT00209495
Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine
NCT02285010
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
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.
Bupivacain
5 mg/mL, 4 mL intrathecally as a single dos
Morphine
0.4 mg/mL; 0.5 mL intrathecally as a single dosage
Propofol
2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery
B
General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
Propofol
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
Fentanyl
100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.
Rocuronbromid
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
Morphine
5 mg is given IV (intravenously) before end of surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bupivacain
5 mg/mL, 4 mL intrathecally as a single dos
Morphine
0.4 mg/mL; 0.5 mL intrathecally as a single dosage
Propofol
2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery
Propofol
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
Fentanyl
100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.
Rocuronbromid
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
Morphine
5 mg is given IV (intravenously) before end of surgery
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Scheduled for abdominal hysterectomy - total or subtotal -on benign gynecological indication.
* At least one ovary planned to be preserved at the hysterectomy.
* Can understand and communicate in Swedish
* Accept participation after written and verbal information and after signed informed consent.
* Has supervision at home after discharge from hospital during the first couple of days and has access to a telephone.
Exclusion Criteria
* ASA classification ≥ Class 3
* Postmenopausal women without HRT (hormone replacement therapy).
* Suspected gynecological malignancy
* Previously undergone bilateral oophorectomy
* Substantial physically disabled so that a normal recovery with early physical mobilization can not be anticipated.
* Mentally or severly psychic disabled
18 Years
60 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Preben Kjolhede
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Preben Kjolhede
Associate professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Preben Kjölhede, MD, PhD
Role: STUDY_CHAIR
Department of Obstetrics and Gynecology, University Hospital, Linköping
Lena Nilsson, MD, PhD
Role: STUDY_DIRECTOR
Department of Anesthesiology, University Hospital, Linköping
Ninnie B. Wodlin, MD
Role: STUDY_DIRECTOR
Department of Obstetrics and Gynecology, University Hospital, Linköping
Kenneth Krohn, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Ostetrics and Gynecology, Vrinnevi Hospital, Norrköping
Lars Nordenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, Vrinnevi Hospital, Norrköping
Mats D. Karlsson, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics and Gynecology, Ryhov Hospital, Jönköping
Veronica Annerhagen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, Ryhov Hospital, Jönköping
Christina Gunnervik, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics and Gynecology, Värnamo Hospital
Magnus Trofast, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, Värnamo Hospital
Tomasz Stypa, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics and Gynecology, Eksjö Hospital
Albert Sundberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, Eksjö Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Eksjö Hospital
Eksjö, , Sweden
Ryhov Hospital
Jönköping, , Sweden
University Hospital
Linköping, , Sweden
Vrinnevi Hospital
Norrköping, , Sweden
Värnamo Hospital
Värnamo, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EudraCT nr 2006-002520-41
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.