Wound Infiltration as Part of an Opioid Free Pain Management Pathway Following Cesarean Delivery

Pain, Postoperative Clinical Trial

Official title:

Randomized Control Trial for an Opioid Free Analgesic Pathway Post Cesarean Delivery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03545516
• Other study ID #: Post Cesarean Pain Management
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 17, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: August 2018
• Source: Richmond University Medical Center
• Contact: Nisha Lakhi, MD
• Phone: 718-818-2109
• Email: NLAKHI[@]RUMCSI.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the effect of three types of wound infiltration on post Cesarean opioid analgesia consumption when used in conjunction with an opioid free postoperative analgesia pathway.

Description:

The subjects that meet the inclusion criteria of the study will be randomized preoperatively into three arms following a 1:1:1 ratio. During the intraoperative course one of three combinations of wound infiltration will be administered to subjects prior to the closure of the surgical incision. Subjects in Group I will receive a placebo of normal saline. Subjects in Group II will receive bupivacaine alone. Subjects in Group III will receive both bupivacaine and dexmedetomidine.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 540
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• All scheduled Cesarean deliveries with intrathecal or epidural anesthesia

Exclusion Criteria:

• Emergency Cesarean deliveries

• Multifetal gestation

• Subjects <18 years old

• Subjects belonging to a vulnerable population (including subjects with a known opioid addiction, subjects with a history of mental illness and prisoners)

• Cesarean delivery with general anesthesia

• Known allergy or hypersensitivity to any of the study medications

• Subjects that can't comprehend the visual analog scale for quantitative pain assessment

Related Conditions & MeSH terms

• Anesthesia, Local
• Opioid Use
• Pain, Postoperative

Intervention

Drug:
• Bupivacaine
Injection of bupivacaine into the surgical incision prior to its closure.
• Dexmedetomidine
Injection of dexmedetomidine ( an adjuvant) into the surgical incision prior to its closure.
• Placebo
Injection of a placebo into the surgical wound

Locations

Country	Name	City	State
United States	Richmond University Medical Center	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Richmond University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of opioid free Cesarean deliveries	Measure the number of Cesarean deliveries that did not require opioid analgesia during the postoperative course	1 year
Secondary	Time to first rescue analgesia	Measure the time to first rescue analgesia from immediate post operative (0 hour) till when the rescue analgesia is administered	0 hour post-cesarean to time rescue analgeisa is administered]
Secondary	Total opioid consumption	Measure the subjects total opioid consumption for the total duration of the postoperative course.	0-14 days
Secondary	Side effects/Adverse reactions	Measure any side effects/allergic reactions attributed to use of any of the study drugs.	0-14 days
Secondary	Postoperative hospital stay	Measure the length of the post-operative hospital stay .	0-14days
Secondary	Complications from procedures	Measure any complications associated with the wound infiltration procedure	0-14 days
Secondary	Breast feeding capacity	Assess the subject's capacity to breast feed during the postoperative course	0-14 days