Optimal Multimodal Analgesia in Abdominal Hysterectomy | NCT00209872

Studies
Optimal Multimodal Analgesia in Abdominal Hysterectomy

NCT00209872

Sponsor

Hvidovre University Hospital

Status

Unknown status

Last Update Posted

Nov 7, 2007Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Planned Abdominal Hysterectomy

Interventions

Gabapentin
Lidocaine
S-ketamine
Epidural analgesia

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
eudraCT # 2005-003595-38

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2007

Last Update Posted Date

Nov 7, 2007Estimated

Description Module

Brief Summary

The purpose of this study is to test the current standard of care (SOC) treatment for abdominal hysterectomy with a group receiving SOC minus epidural analgesia plus additional perioperative analgesics in terms of postoperative abilities, postoperative nausea and vomiting (PONV), pain and discharge time from the PACU (post-anaesthesia care unit).

Detailed Description

Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups, for patients admitted for planned abdominal hysterectomy with or without BSO:

A: standard of care (SOC) receiving paracetamol, celecoxib, epidural analgesia, dexamethasone, ondansetron and droperidol, and general anaesthesia with propofol, remifentanil and cisatracurium
B: SOC with sham epidural analgesia, preoperative gabapentin, intraoperative lidocaine, s-ketamine and sufentanil

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative abilities over time
Discharge time from PACU according to fixed criteria
Consumption of analgesics and antiemetics in the PACU

Secondary Outcomes

Measure	Description	Time Frame
Degree of nursing requirements at the PACU
General tolerability of the regimes
Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Planned abdominal hysterectomy with or without BSO
Age above 18 years
Written informed consent
American Society of Anesthesiologists (ASA) class I-III

Exclusion Criteria:

Planned vaginal or laparoscopic hysterectomy
Hysterectomy as part of other surgery
Allergy to part of the treatment regimen
Previous reactions to opioids (nausea, cognition)
Previous inability to place correct epidural catheter
Severe state anxiety according to the OCAP or STAI
ASA class IV
Dependency on alcohol, opioids or central stimulants
Chronic pain condition
Hemorrhagic diathesis
Participation in another study

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kenneth Jensen, M.D.	Contact	+45 36 32 62 90		kenneth.jensen@hh.hosp.dk

Overall Officials

Name	Affiliation	Role
Kenneth Jensen, M.D.	Dept. of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark	Principal Investigator
Claus Lund, Dr. Med. Sci.	Dept. of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Anaesthesia, Hvidovre Hospital		Copenhagen	Hvidovre	2650	Denmark

Label	URL
URL looking into anaesthesia and surgery for abdominal hysterectomy	View source

Intervention Browse Module

MeSH Terms

ID	Term
D000077206	Gabapentin
D008012	Lidocaine
C000629870	Esketamine
D015360	Analgesia, Epidural

Ancestor Terms

ID	Term
D000588	Amines
D009930	Organic Chemicals
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Gabapentin	Drug
Lidocaine	Drug
S-ketamine	Drug
Epidural analgesia	Procedure