Infiltration Analgesia After Caesarean Section

NCT01094106 | Completed Phase 4 Results

• 1 other identifier: NCCHAne001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Caesarean Section

Keywords

postoperative pain; infiltration analgesia; ropivacaine; Caesarean Section

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours

Secondary Outcomes (2)

• Strength of Pain on Numerical Rating Scale (NRS)

  48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h)

• Postoperative Nausea and Vomiting (PONV)

  48 hours

Study Arms (2)

Ropivacaine 0,75%

ACTIVE COMPARATOR

Postoperative wound infusion 15 mg /h / 48h

Drug: Ropivacaine 0,75%

NaCl 0,9%

PLACEBO COMPARATOR

Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h

Drug: NaCl 0,9%

Interventions

Ropivacaine 0,75% DRUG

Postoperative wound infusion 2 ml/ h/ 48h

Ropivacaine 0,75%

NaCl 0,9% DRUG

Postoperative wound infusion 2 ml/h/48h

NaCl 0,9%

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• volunteer
• age over 18 years
• spinal anesthesia
• ASA 1-2
• no allergy to used medications
• no medications which have effect on pain perception

You may not qualify if:

• patient's refusal to participate
• marked systemic disease

Sponsors & Collaborators

• North Karelia Central Hospital: lead

Study Sites (1)

North Karelia Central hospital

Joensuu, 80880, Finland

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Matti Reinikainen
• Organization: Kuopio University Hospital

matti.reinikainen@kuh.fi

+358447176681

Study Officials

• Sakari Syväoja, MD

  North Carelia CH, Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 26, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 18, 2020
• Results First Posted: August 18, 2020

Record last verified: 2020-08

Locations

FI (1)