Hysterectomy (MeSH nr: E04.950.300.399)Phase 4NCT00527332

Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy

A Phase 4 study testing Bupivacain, Morphine and Propofol in people with Hysterectomy (MeSH nr: E04.950.300.399), run by Preben Kjolhede at 5 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 60 years, women only
Conditions the study is for: Hysterectomy (MeSH nr: E04.950.300.399)
What is being tested?: Bupivacain, Morphine and Propofol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 5 sitesSweden
Study dates: Mar 2007to Dec 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Women only
No healthy volunteers
Adult

Who may be able to join

Female between 18 and 60 years of age.
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.

Who cannot join

Contra-indications against spinal or general anesthesia or the standard dosage of the study drugs
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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Sweden5 sites

Eksjö Hospital
Eksjö, 57581
Ryhov Hospital
Jönköping, 55185
University Hospital
Linköping, 58185
Vrinnevi Hospital
Norrköping, 60182
Värnamo Hospital
Värnamo, 33185

Other trials in Sweden

About this study

Official title: General Anesthesia Versus Spinal Anesthesia Combined With Intrathecal Morphine in Abdominal Hysterectomy for Benign Gynecological Diseases. A Randomized Open Controlled Study.

Conditions: Hysterectomy (MeSH nr: E04.950.300.399)
Being tested: Bupivacain, Morphine, Propofol, Fentanyl, Rocuronbromid
Keywords: Hospitalization, Postoperative care, Quality of Life, Health economy, Anesthesia. Spinal, Anesthesia, General

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BupivacainDrug
Also called Marcain spinal tung., ATC-code: N01BB01
5 mg/mL, 4 mL intrathecally as a single dos
MorphineDrug
Also called Morfin Special, ATC-code: N02AA01
0.4 mg/mL; 0.5 mL intrathecally as a single dosage
PropofolDrug
Also called ATC-code: N01AX10
2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery
PropofolDrug
Also called ATC-code: N01AX10
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
FentanylDrug
Also called ATC-code:N01AH01
100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.
RocuronbromidDrug
Also called Esmeron, ATC-code: M03AC09
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
MorphineDrug
Also called ATC-code: N02AA01
5 mg is given IV (intravenously) before end of surgery

Study groups in NCT00527332
Study group	Role	What they receive
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. Receives: Drug: Bupivacain; Drug: Morphine; Drug: 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. Receives: Drug: Propofol; Drug: Fentanyl; Drug: Rocuronbromid; Drug: Morphine

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Hospital Stay.
Duration of hospital stay defined as time from start anesthesia to leaving the hospital
Measured: Within 6 months after surgery

Secondary outcomes (7)

Occurrence and Degree of Postoperative Symptoms.
Measured: Within 6 months after the surgery
Postoperative Consumption of Analgesics and Antiemetics.
Measured: Within 6 months after surgery
Complications and Complication Rates.
Measured: Within 6 months after the surgery
Quality of Life and QALYs (Quality Adjusted Life Years).
Measured: Within 6 months after the surgery
Sick Leave.
Measured: Within 6 months after the surgery
The Stress Coping Ability Impact on Postoperative Symptoms and Recovery.
Measured: Within 6 months after the surgery
Health-related Economy.
Measured: Within 6 months after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Dec 2009

First posted10 Sep 2007 (estimated)
Study startMar 2007
Primary completionJun 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Hysterectomy (MeSH nr: E04.950.300.399)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00527332
Sponsor's protocol ID: EudraCT nr 2006-002520-41
Status last verified: Jan 2012
First submitted: 7 Sep 2007
Last updated: 26 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 12095591
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.
PubMed 11222424
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.
PubMed 11516794
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.
PubMed 16956334
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.
PubMed 12911451
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.
PubMed 22893770
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.
PubMed 22568450

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: General Anesthesia Versus Spinal Anesthesia Combined With Intrathecal Morphine in Abdominal Hysterectomy for Benign Gynecological Diseases. A Randomized Open Controlled Study.
ClinicalTrials.gov ID: NCT00527332
Acronym / sponsor ID: EudraCT nr 2006-002520-41
Conditions: Hysterectomy (MeSH nr: E04.950.300.399)
Keywords: Hospitalization, Postoperative care, Quality of Life, Health economy, Anesthesia. Spinal, Anesthesia, General
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Preben KjolhedeUniversity, hospital or other
Study start: Mar 2007
Primary completion: Jun 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 10 Sep 2007 (estimated)
Results: Posted 21 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Active comparator	Drug: Bupivacain, Drug: Morphine, Drug: PropofolSpinal 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	Drug: Propofol, Drug: Fentanyl, Drug: Rocuronbromid, Drug: MorphineGeneral anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Female between 18 and 60 years of age.
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.

Key exclusion criteria (7 listed)

Contra-indications against spinal or general anesthesia or the standard dosage of the study drugs
ASA classification ≥ Class 3
Postmenopausal women without HRT (hormone replacement therapy).
Suspected gynecological malignancy
Previously undergone bilateral oophorectomy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BupivacainAlso: Marcain spinal tung., ATC-code: N01BB015 mg/mL, 4 mL intrathecally as a single dos	Drug	A
MorphineAlso: Morfin Special, ATC-code: N02AA010.4 mg/mL; 0.5 mL intrathecally as a single dosage	Drug	A
PropofolAlso: ATC-code: N01AX102-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery	Drug	A
PropofolAlso: ATC-code: N01AX10Induction 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	Drug	B
FentanylAlso: ATC-code:N01AH01100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.	Drug	B
RocuronbromidAlso: Esmeron, ATC-code: M03AC090.6 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	Drug	B
MorphineAlso: ATC-code: N02AA015 mg is given IV (intravenously) before end of surgery	Drug	B

Primary outcome

Duration of Hospital Stay.
Time frame: Within 6 months after surgery
Duration of hospital stay defined as time from start anesthesia to leaving the hospital

7 secondary outcomes

Occurrence and Degree of Postoperative Symptoms.
Time frame: Within 6 months after the surgery
Postoperative Consumption of Analgesics and Antiemetics.
Time frame: Within 6 months after surgery
Complications and Complication Rates.
Time frame: Within 6 months after the surgery
Quality of Life and QALYs (Quality Adjusted Life Years).
Time frame: Within 6 months after the surgery
Sick Leave.
Time frame: Within 6 months after the surgery
The Stress Coping Ability Impact on Postoperative Symptoms and Recovery.
Time frame: Within 6 months after the surgery
Health-related Economy.
Time frame: Within 6 months after the surgery

Results and safety

Results posted to the registry on 21 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spinal Anesthesia	91	82
General Anesthesia	89	80

Primary outcome: Duration of Hospital Stay.

Time frame: Within 6 months after surgery. Median (Full Range). Unit: Hours

Measure	Spinal Anesthesia n = 82	General Anesthesia n = 80
Value	46 (22 to 125)	50 (24 to 100)

Population analysed: Participants who completed the study were analyzed

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spinal Anesthesia	7 of 91 (7.7%)	17 of 91 (18.7%)	Not reported
General Anesthesia	10 of 89 (11.2%)	16 of 89 (18%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundVårdtid, 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.
Background: PubMed 12095591Kehlet 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.
Background: PubMed 11222424Wilmore 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.
Background: PubMed 11516794Moller 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.
Background: PubMed 16956334Persson 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.
Background: PubMed 12911451Ellstrom 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.
Derived from this study: PubMed 22893770Kjolhede 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.
Derived from this study: PubMed 22568450Kjolhede 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Preben Kjölhede, MD, PhD study chair

Department of Obstetrics and Gynecology, University Hospital, Linköping

Lena Nilsson, MD, PhD study director

Department of Anesthesiology, University Hospital, Linköping

Ninnie B. Wodlin, MD study director

Department of Obstetrics and Gynecology, University Hospital, Linköping

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacain, Morphine and Propofol in people with Hysterectomy (MeSH nr: E04.950.300.399), run by Preben Kjolhede at 5 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Hospital Stay. (time frame: Within 6 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00527332, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2012.