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

Study Overview
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Brief Summary
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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).

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

Conditions
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Neuromuscular Blockade, Pain, Laparoscopy

Intervention / Treatment
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* Drug: Rocuronium
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Deep neuromuscular blockade<br>Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron | Drug: Rocuronium<br> <br> |
| Placebo Comparator: Moderate neuromuscular blockade<br>Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain | 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). | within 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | 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. | within 14 days |