The postoperative pain and morphine consumption after Total Laparoscopic Hysterectomy MedDRA version: 20.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Ropivacaine
Product Code: N01BB09
Pharmaceutical Form: Injection
INN or Proposed INN: Ropivacaine
Other descriptive name: RO
Sponsors
Zealand University Hospital Roskilde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Participants in the study should fullfil the following criteria in order to be included: - Scheduled for TLH - Age > 17 years at the date of inclusion Have received thorough information, orally and in written, and signed the “Informed Consent” form on participation in the trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Exclusion criteria: Either of the following criteria will lead to exclusion of the patient of the study: Inability to cooperate Inability to speak, read and understand Danish Allergy to local anaesthetics or opioids Daily intake of opioids, according to the investigators decision Local infection at the site of injection or systemic infection Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration Co-morbidity, ASA>3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim: Our aim with this study is to investigate the efficacy of the Ultrasound-guided (USG) Transmuscular Quadratus Lumborum (TQL) block vs. Placebo in patients undergoing Total Laparoscopic Hysterectomy (TLH). Our hypothesis is that the bilateral TQL block will significantly reduce the opioid consumption during the first 12 postoperative hours. ;Secondary Objective: Our hypothesis is that the bilateral TQL block will significantly reduce the Numerical Rating Scale (NRS) pain score (0-10/10), opioid related side effects, times to first opioid and times to ambulation.; Primary end point(s): The primary outcome of the study will be: Morphine consumption in the first 12 postoperative hours (data from PCA pump and the patient’s medical record). ;Timepoint(s) of evaluation of this end point: Twelve hours after arrival at the Post Anesthesia Care Unit (PACU) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcomes will be: (A) Pain intensity (NRS 0-10/10) in the study period at T0 (arrival in the PACU), after 15, 30 and 45 minutes. And again at 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 18, 21 and 24 hours postoperatively. In addition, NRS score for pain will be recorded electronically in relation to all morphine administrations, since all patients must enter their NRS pain score on the Patient-Controlled-Analgesia (PCA) pump display in relation to administration of the PCA boluses. (B) Total morphine consumption. Morphine consumption at 3, 6, 9, 12, 18 and 24 postoperative hours. (C) Duration of block (time to first opioid). (D) Patient satisfaction with application of the block. (E) The degree of morphine-related side effects (PONV, itching, fatigue, etc.). (F) Time from operation to ambulation. ;Timepoint(s) of evaluation of this end point: Twentyfour hours after arrival at the Post Anesthesia Care Unit | — |
Countries
Denmark
Contacts
Public ContactJens Børglum
Dept. of Anesth. Zealand University Hospital Roskilde
Outcome results
None listed