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

Phase 4

Completed

• Conditions: Laparoscopy; Pain; Neuromuscular Blockade
• Interventions: Drug: placebo; Drug: Rocuronium

• Registration Number: NCT01722097
• Lead Sponsor: Herlev Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-02
• Study First Submitted QC: 2012-11-05
• Study First Posted: 2012-11-06
• Primary Completion: 2014-03
• Study Completion: 2014-07
• Results First Submitted: 2015-08-18
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-21
• Last Update Submitted: 2015-09-21
• Results First Posted: 2015-10-21
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate neuromuscular blockade	placebo	Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
Deep neuromuscular blockade	Rocuronium	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of anesthesia and department of minimal invasive gynecology, Aleris-Hamlet; 🇩🇰 Søborg, Denmark