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Completed

NCT Number: NCT01722097

Recovery After Laparoscopic Hysterectomy With Deep Neuromuscular Blockade and Low Intra-abdominal Pressure

The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain. Patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmHg).

Primary hypothesis:

Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).

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Key information

Conditions

Neuromuscular Blockade Laparoscopy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of anesthesia and department of minimal invasive gynecology, Aleris-Hamlet

Søborg, 2830, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective laparoscopic hysterectomy (total/subtotal)
  • Can read and understand Danish
  • Informed consent

Exclusion criteria

  • BMI > 30 kg/cm2
  • Known allergy to medications that are included in the project
  • Severe renal disease, defined by S-creatinine > 0,200 mmol/L, GFR < 30ml/min or hemodialysis)
  • Neuromuscular disease that may interfere with neuromuscular data
  • Lactating
  • Impaired liver function
  • Indication for rapid sequence induction (esophageal reflux/ hiatus hernia/other cause)

Treatment and study plan

Rocuronium

Drug

Placebo

Drug

Primary outcomes

  1. Shoulder Pain

    Time frame: within 14 days

    Number of participants with shoulder pain or discomfort (VAS > 20) in the shoulder region within 14 days after operation.

    VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100).

Secondary outcomes

  1. Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)

    Time frame: within 14 days

    Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 4 days after operation.

    Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 14 days after operation.

    Pain was assessed: preoperatively, at arrival to the postanesthesia care unit, 2 hours after surgery, 4 hours after surgery, 8 hours after surgery, at discharge from hospital, and once daily at day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 after surgery.

Other outcomes

  1. Patient-movements

    Time frame: During surgery

    Number of unintended and unwanted patient-movements registered by the surgeon

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 6, 2012
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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