Phase 4
Completed N=110
Recovery After Laparoscopic Hysterectomy With Deep Neuromuscular Blockade and Low Intra-abdominal Pressure
Neuromuscular Blockade · Postoperative Pain · Laparoscopy
Source: ClinicalTrials.gov NCT01722097 ↗
Enrolled (actual)
110
Serious AEs
6.4%
Results posted
Oct 2015
Primary outcomePrimary: Shoulder Pain — 14; 30 participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Shoulder Pain |
14; 30 | — |
| SECONDARY Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) |
16.4; 28.5; 27.6; 36.3; 88.4; 102.2 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01722097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.