Optimal Multimodal Analgesia in Abdominal Hysterectomy

NCT ID: NCT00209872

Last Updated: 2007-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Planned Abdominal Hysterectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gabapentin

Intervention Type DRUG

Lidocaine

Intervention Type DRUG

S-ketamine

Intervention Type DRUG

Epidural analgesia

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hvidovre University Hospital

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kenneth Jensen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark

Claus Lund, Dr. Med. Sci.

Role: STUDY_CHAIR

Dept. of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dept. of Anaesthesia, Hvidovre Hospital

Copenhagen, Hvidovre, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kenneth Jensen, M.D.

Role: CONTACT

Phone: +45 36 32 62 90

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kenneth Jensen, M.D.

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

http://www.postoppain.org

URL looking into anaesthesia and surgery for abdominal hysterectomy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

eudraCT # 2005-003595-38

Identifier Type: -

Identifier Source: secondary_id

OMA-AH01

Identifier Type: -

Identifier Source: org_study_id