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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722097
• Other study ID #: NMBDK2012
• Secondary ID: 2012-003787-51
• Status: Completed
• Phase: Phase 4
• First received: November 2, 2012
• Last updated: September 21, 2015
• Start date: November 2012
• Est. completion date: July 2014

Study information

• Verified date: September 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopy
• Neuromuscular Blockade
• Pain

Intervention

Drug:
• Rocuronium

• placebo

Locations

Country	Name	City	State
Denmark	Department of anesthesia and department of minimal invasive gynecology, Aleris-Hamlet	Søborg

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-movements	Number of unintended and unwanted patient-movements registered by the surgeon	During surgery	Yes
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).	within 14 days	No
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.	within 14 days	No