Phase 4
N=67
Infiltration Analgesia After Caesarean Section
Pain, Postoperative · Caesarean Section
Bottom Line
View on ClinicalTrials.gov: NCT01094106 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: The Demand of Rescue Analgesics (Oxycodone) — 47.5; 57.8 mg — p=0.10
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ropivacaine 0,75% (Drug); NaCl 0,9% (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- North Karelia Central Hospital
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Demand of Rescue Analgesics (Oxycodone) |
47.5; 57.8 | 0.10 |
| SECONDARY Strength of Pain on Numerical Rating Scale (NRS) |
5; 6; 3; 3.75; 3; 3 | 0.08 |
| SECONDARY Postoperative Nausea and Vomiting (PONV) |
7; 11 | 0.30 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01094106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.