Optimal Multimodal Analgesia in Abdominal Hysterectomy

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).

Intervention / Treatment

  • Gabapentin (DRUG)
    N/A
  • Lidocaine (DRUG)
    N/A
  • S-ketamine (DRUG)
    N/A
  • Epidural analgesia (PROCEDURE)
    N/A

Condition or Disease

  • Planned Abdominal Hysterectomy

Phase

  • Phase 4
  • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 60 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Oct 01, 2005
    Primary Completion: Aug 31, 2020
    Completion Date: Aug 31, 2020
    Study First Posted: Sep 21, 2005 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 06, 2007

    Sponsors / Collaborators

    Responsible Party: N/A
    No responsible party listed

    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

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Postoperative abilities over time
    • Discharge time from PACU according to fixed criteria
    • Consumption of analgesics and antiemetics in the PACU
    Secondary Outcomes
    • 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

    More Details

    NCT Number: NCT00209872
    Other IDs: OMA-AH01
    Study URL: https://clinicaltrials.gov/study/NCT00209872
    Last updated: Sep 29, 2023