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Optimal Multimodal Analgesia in Abdominal Hysterectomy

H

Hvidovre University Hospital

Status and phase

Unknown
Phase 4

Conditions

Planned Abdominal Hysterectomy

Treatments

Drug: Lidocaine
Drug: S-ketamine
Drug: Gabapentin
Procedure: Epidural analgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT00209872
OMA-AH01
eudraCT # 2005-003595-38

Details and patient eligibility

About

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).

Full 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

Enrollment

60 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Kenneth Jensen, M.D.

Data sourced from clinicaltrials.gov

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