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

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).

Study Overview

• Status: Completed
• Conditions: Pain; Laparoscopy; Neuromuscular Blockade
• Intervention / Treatment: Drug: placebo; Drug: Rocuronium

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Søborg, Denmark, 2830
    • Department of anesthesia and department of minimal invasive gynecology, Aleris-Hamlet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Rocuronium
Placebo Comparator: Moderate neuromuscular blockade; Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron	Drug: placebo

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-movements	Number of unintended and unwanted patient-movements registered by the surgeon	During surgery

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Investigators: Study Chair: Mona Gätke, MD, ph.d., Department of Anesthesia, Herlev Hospital; Principal Investigator: Matias Vested Maden, MD, Department of Anesthesia, Herlev Hospital

Publications and helpful links

General Publications

• Madsen MV, Istre O, Springborg HH, Staehr-Rye AK, Rosenberg J, Lund J, Gatke MR. Deep neuromuscular blockade and low insufflation pressure during laparoscopic hysterectomy. Dan Med J. 2017 May;64(5):A5364.
• Madsen MV, Istre O, Staehr-Rye AK, Springborg HH, Rosenberg J, Lund J, Gatke MR. Postoperative shoulder pain after laparoscopic hysterectomy with deep neuromuscular blockade and low-pressure pneumoperitoneum: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):341-7. doi: 10.1097/EJA.0000000000000360.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: November 2, 2012
• First Submitted That Met QC Criteria: November 5, 2012
• First Posted (Estimate): November 6, 2012

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: NMBDK2012; 2012-003787-51 (EudraCT Number)