Treatment of postoperative pain after elective caesarean section. MedDRA version: 20.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863 MedDRA version: 20.0 Level: LLT Classification code 10006832 Term: C-section System Organ Class: 100000004865
Conditions
Sponsors
Zealand university hospital, Roskilde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants in the study need to fulfil the following criteria in order to be included: - 18 years old or more - Scheduled for elective Caesarean Section in spinal anaesthesia - Have received thorough information, verbally 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 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Either of the following criteria will lead to exclusion of the parturient of the study: - Inability to cooperate - Inability to understand Danish - Allergy to local anaesthetics or opioids - Excessive daily intake of opioids, according to the discretion of the investigator - Local infection at the site of injection or systemic infection - Difficult visualisation of muscular and fascial structures on ultrasound, necessary to correct blockade and catheter placement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to investigate whether it is possible to prolong time to first opioid with the TQL block by inserting catheters bilaterally, providing continuous analgesia, in patients undergoing elective CS. Our hypothesis is that it will be possible to significantly extend time to first opioid with the blockade by 66.6%, increasing it from a mean of 5.6 hours to a mean of 10 hours, and that bilateral TQL catheters will significantly reduce the Numerical Rating Scale (NRS) pain score (0-10/10) compared to the placebo group.;Secondary Objective: Not applicable;Primary end point(s): Time to first opioid.;Timepoint(s) of evaluation of this end point: 24 hours postoperative | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (A) Pain intensity (NRS 0-10/10) in the study period at 3, 6, 9, 12 and 24 hours postoperatively. In addition, NRS score will be recorded electronically on all morphine administrations, since all patients must enter their NRS score on the Patient-Controlled Analgesia (PCA) pump display prior to administration of the PCA boluses. (B) Total morphine consumption. Morphine consumption at 3, 6, 9, 12 and 24 postoperative hours (data from PCA pump and patient medical record). (C) Frequency of displacement of catheters (early displacement evaluated after 2 hours (T2), late displacement evaluated after 24 hours (T24)). (D) Patient satisfaction with application of the catheters. (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: 24 hours postoperative | — |
Countries
Denmark
Contacts
Public ContactJens Børglum
Dept. of Anaesth., Zealand university hospital, Roskilde
Outcome results
None listed