Infiltration Analgesia After Caesarean Section
Primary Purpose
Pain, Postoperative, Caesarean Section
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Ropivacaine 0,75%
NaCl 0,9%
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring postoperative pain, infiltration analgesia, ropivacaine, Caesarean Section
Eligibility Criteria
Inclusion Criteria:
- volunteer
- age over 18 years
- spinal anesthesia
- ASA 1-2
- no allergy to used medications
- no medications which have effect on pain perception
Exclusion Criteria:
- patient's refusal to participate
- marked systemic disease
Sites / Locations
- North Karelia Central hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ropivacaine 0,75%
NaCl 0,9%
Arm Description
Postoperative wound infusion 15 mg /h / 48h
Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h
Outcomes
Primary Outcome Measures
The Demand of Rescue Analgesics (Oxycodone)
The amount of oxycodone required 48 hours after operation. Oxycodone was administered when the strength of pain is over 3 on numeric rating scale (NRS) 0-10.
Secondary Outcome Measures
Strength of Pain on Numerical Rating Scale (NRS)
Intensity of pain was recorded on a numerical rating scale (0-10), where higher scores mean more severe pain, during rest and when moving, for five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h); for each time interval, the highest recorded pain score was taken into account.
Postoperative Nausea and Vomiting (PONV)
The numbers of patients with at least mild nausea at any time post-operatively.
Full Information
NCT ID
NCT01094106
First Posted
March 12, 2010
Last Updated
August 6, 2020
Sponsor
North Karelia Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01094106
Brief Title
Infiltration Analgesia After Caesarean Section
Official Title
Local Infiltration Analgesia for Postoperative Pain After Caesarean Section. A Prospective, Randomised, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Karelia Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Infiltration of a local anesthetic into the surgical wound is a simple method to strive to control postoperative pain after surgery. In the investigators institution, this method is used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover, the cost of the single use elastomeric pump used with this procedure is clearly higher than the costs of other routinely used analgesic methods.
According to the investigators observations, infiltration of a local anesthetic into the surgical wound after caesarean section seems to reduce the need for rescue analgesics. However, the scientific evidence of the efficacy of this technique is weak. The investigators decided to conduct a prospective, controlled, randomised, double blind trial on this topic.
The hypothesis is that wound infiltration with local anesthetic will reduce postoperative pain and opioid consumption after caesarean section without major adverse effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Caesarean Section
Keywords
postoperative pain, infiltration analgesia, ropivacaine, Caesarean Section
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ropivacaine 0,75%
Arm Type
Active Comparator
Arm Description
Postoperative wound infusion 15 mg /h / 48h
Arm Title
NaCl 0,9%
Arm Type
Placebo Comparator
Arm Description
Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0,75%
Intervention Description
Postoperative wound infusion 2 ml/ h/ 48h
Intervention Type
Drug
Intervention Name(s)
NaCl 0,9%
Intervention Description
Postoperative wound infusion 2 ml/h/48h
Primary Outcome Measure Information:
Title
The Demand of Rescue Analgesics (Oxycodone)
Description
The amount of oxycodone required 48 hours after operation. Oxycodone was administered when the strength of pain is over 3 on numeric rating scale (NRS) 0-10.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Strength of Pain on Numerical Rating Scale (NRS)
Description
Intensity of pain was recorded on a numerical rating scale (0-10), where higher scores mean more severe pain, during rest and when moving, for five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h); for each time interval, the highest recorded pain score was taken into account.
Time Frame
48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h)
Title
Postoperative Nausea and Vomiting (PONV)
Description
The numbers of patients with at least mild nausea at any time post-operatively.
Time Frame
48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
volunteer
age over 18 years
spinal anesthesia
ASA 1-2
no allergy to used medications
no medications which have effect on pain perception
Exclusion Criteria:
patient's refusal to participate
marked systemic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sakari Syväoja, MD
Organizational Affiliation
North Carelia CH, Department of Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Karelia Central hospital
City
Joensuu
ZIP/Postal Code
80880
Country
Finland
12. IPD Sharing Statement
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Infiltration Analgesia After Caesarean Section
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