Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery

Pain Clinical Trial

Official title:

Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829944
• Other study ID #: Pro00069752
• Status: Completed
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: September 2019

Study information

• Verified date: February 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the infusion of the local anesthetic ropivacaine (a numbing medicine) and the non-steroidal anti-inflammatory drug ketorolac (a pain killer similar to ibuprofen) through a catheter placed along the cesarean delivery incision, will reduce the pain experienced after cesarean section and need for narcotic pain medicine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiology (ASA) class 1,2, and 3

• English speaking women at a gestational age > 37 weeks

• scheduled for cesarean delivery under spinal or combined spinal epidural anesthesia

Exclusion Criteria:

• BMI > 50 kg/m2

• history of intravenous drug or opioid abuse

• previous history of chronic pain syndrome

• history of opioid use in the past week

• allergy or contraindication to any of the study medications

• non-English speaking

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine

• Ketorolac

• Placebo

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score on Movement (Sitting in Bed From a Supine Position)	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	24 hours after surgery
Secondary	Pain Scores at Rest	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	2 hours
Secondary	Pain Scores at Rest	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	24 hours
Secondary	Pain Scores at Rest	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	48 hours
Secondary	Opioid Consumption	measured in mg oxycodone equivalents	2 hours
Secondary	Opioid Consumption	measured in mg oxycodone equivalents	24 hours
Secondary	Opioid Consumption	measured in mg oxycodone equivalents	48 hours
Secondary	Time to First Rescue Analgesic		48 hours
Secondary	Number of Subjects Experiencing Nausea	Asking patients whether or not they experienced the symptom in the preceding time-frame	2 hours
Secondary	Number of Subjects Experiencing Nausea	Asking patients whether or not they experienced the symptom in the preceding time-frame	24 hours
Secondary	Number of Subjects Experiencing Nausea	Asking patients whether or not they experienced the symptom in the preceding time-frame	48 hours
Secondary	Number of Subjects Experiencing Vomiting	Asking patients whether or not they experienced the symptom in the preceding time-frame	2 hours
Secondary	Number of Subjects Experiencing Vomiting	Asking patients whether or not they experienced the symptom in the preceding time-frame	24 hours
Secondary	Number of Subjects Experiencing Vomiting	Asking patients whether or not they experienced the symptom in the preceding time-frame	48 hours
Secondary	Number of Subjects Experiencing Pruritus	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	2 hours
Secondary	Number of Subjects Experiencing Pruritus	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	24 hours
Secondary	Number of Subjects Experiencing Pruritus	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	48 hours
Secondary	Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale	Score reported on a scale of 0-10, with 0 being not at all satisfied and 10 being completely satisfied	48 hours
Secondary	Number of Subjects With Chronic Pain	Phone interview asking patient about presence of pain at incision site	8 weeks
Secondary	Number of Subjects With Chronic Pain	Phone interview asking patient about presence of pain at incision site	6 months
Secondary	Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale	Patients contacted over the phone completed screening with the EPDS, on a scale of 0-30. A score of over 13 indicate risk for postpartum depression	8 weeks
Secondary	Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale	Patients contacted over the phone completed screening with the EPDS, on a scale of 0-30. A score of over 13 indicate risk for postpartum depression	6 months
Secondary	Pain Score on Movement	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	48 hours after surgery