Recovery after laparoscopic removal of the uterus with muscle relaxation and low intraabdominal pressure

Phase 1

• Conditions: The pain study:To evaluate the importance of deep neuromuscular blockade (NMB) and low intraabdominal pressure in laparoscopic hysterectomy considering postoperative pain, nausea, consumption of analgetics, lengths of hospital stay and time to recover to normal functions.The safety study: To evaluate the importance of deep neuromuscular blockade (NMB) in laparoscopic hysterectomy considering the number unintended and unwanted patient movements registered by the surgeon.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2012-003787-51-DK
• Lead Sponsor: Mona Ring Gätke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-23
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

Patients > 18 years old
Elective laparoscopic hysterectomy (total/subtotal)
Can read and understand Danish
Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

BMI > 28 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 or pregnant
Impaired liver function
Indication for rapid sequence induction (esophageal reflux/ hiatus hernia/other cause)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The pain study:<br>To evaluate the importance of deep neuromuscular blockade (NMB) and low intraabdominal pressure in laparoscopic hysterectomy considering postoperative shoulderpain<br> <br>;Secondary Objective: To evaluate the importance of deep neuromuscular blockade (NMB) and low intraabdominal pressure in laparoscopic hysterectomy considering postoperative pain, nausea, consumption of analgetics, lengths of hospital stay and time to recover to normal functions.;Primary end point(s): Occurrence of shoulder pain or discomfort in the shoulder region within 14 days after operation;Timepoint(s) of evaluation of this end point: 14 days after hysterectomy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 4 days after operation <br>Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 14 days after operation <br>Number of days before resumption of daily acitivities<br>Number of days before resumption of work<br>;Timepoint(s) of evaluation of this end point: Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 4 days after operation <br>Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 14 days after operation <br>Number of days before resumption of daily acitivities<br>Number of days before resumption of work<br>