Laparoscopy, Neuromuscular Blockade, Pain
Conditions
Brief 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).
Interventions
DRUGRocuronium
DRUGplacebo
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient-movements | During surgery | Number of unintended and unwanted patient-movements registered by the surgeon |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Deep Neuromuscular Blockade 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
Rocuronium | 55 |
| Moderate Neuromuscular Blockade Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
placebo | 55 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient sheets not returned | 6 | 5 |
Baseline characteristics
| Characteristic | Deep Neuromuscular Blockade | Moderate Neuromuscular Blockade | Total |
|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 5 | 48 years STANDARD_DEVIATION 5 | 47 years STANDARD_DEVIATION 5 |
| American Society of Anesthesiologists Physical Status Classification 1 | 52 participants | 49 participants | 101 participants |
| American Society of Anesthesiologists Physical Status Classification 2 | 3 participants | 6 participants | 9 participants |
| BMI | 23.1 kg/m^2 STANDARD_DEVIATION 3 | 24.2 kg/m^2 STANDARD_DEVIATION 3.1 | 23.6 kg/m^2 STANDARD_DEVIATION 3.1 |
| Parity (full term pregnancies) | 2 pregnancies | 2 pregnancies | 2 pregnancies |
| Previous abdominal surgery | 26 participants | 35 participants | 61 participants |
| Region of Enrollment Denmark | 55 participants | 55 participants | 110 participants |
| Sex/Gender, Customized women | 55 participants | 55 participants | 110 participants |
| Subtotal hysterectomy | 26 participants | 27 participants | 53 participants |
| Total hysterectomy | 29 participants | 28 participants | 57 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 4 / 55 | 3 / 55 |
Outcome results
Primary
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).
Time frame: within 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deep Neuromuscular Blockade | Shoulder Pain | 14 participants |
| Moderate Neuromuscular Blockade | Shoulder Pain | 30 participants |
Secondary
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.
Time frame: within 14 days
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Deep Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS abdominal pain 4 days AUC | 102.4 units on a scale*days |
| Deep Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS incisional pain 4 days AUC | 88.4 units on a scale*days |
| Deep Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS abdominal pain 14 days AUC | 190.8 units on a scale*days |
| Deep Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS shoulder pain 14 days AUC | 27.6 units on a scale*days |
| Deep Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS overall pain 4 days AUC | 101.7 units on a scale*days |
| Deep Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS incisional pain 14 days AUC | 144.6 units on a scale*days |
| Deep Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS overall pain 14 days AUC | 190.2 units on a scale*days |
| Deep Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS shoulder pain 4 days AUC | 16.4 units on a scale*days |
| Moderate Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS overall pain 14 days AUC | 256.9 units on a scale*days |
| Moderate Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS shoulder pain 14 days AUC | 36.3 units on a scale*days |
| Moderate Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS incisional pain 4 days AUC | 102.2 units on a scale*days |
| Moderate Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS incisional pain 14 days AUC | 150.8 units on a scale*days |
| Moderate Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS abdominal pain 4 days AUC | 114.1 units on a scale*days |
| Moderate Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS abdominal pain 14 days AUC | 215.5 units on a scale*days |
| Moderate Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS overall pain 4 days AUC | 129.8 units on a scale*days |
| Moderate Neuromuscular Blockade | Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain) | VAS shoulder pain 4 days AUC | 28.5 units on a scale*days |
Other Pre-specified
Patient-movements
Number of unintended and unwanted patient-movements registered by the surgeon
Time frame: During surgery