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

Phase 4CompletedNCT01722097

Herlev Hospital110 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

110

Conditions

Neuromuscular Blockade Pain Laparoscopy

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.