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

NCT03545516 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: Post Cesarean Pain Management
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative; Anesthesia, Local; Opioid Use

Keywords

Wound infiltration; Post Cesarean; Pain management; bupivacaine; dexmedetomidine; postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time to first rescue analgesia

  0 hour post-cesarean to time rescue analgeisa is administered]

• Total opioid consumption

  0-14 days

• Side effects/Adverse reactions

  0-14 days

• Postoperative hospital stay

  0-14days

• Complications from procedures

  0-14 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Wound infiltration with a placebo

Drug: Placebo

Bupivacaine

EXPERIMENTAL

Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine diluted with 5 mL of normal saline to give a 25 mL

Drug: Bupivacaine

Bupivacaine and Dexmedetomidine

EXPERIMENTAL

Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine and 1.5 mcg/kg of dexmedetomidine will be diluted with normal saline to make 25 mL of solution .

Drug: Bupivacaine; Drug: Dexmedetomidine

Interventions

Bupivacaine DRUG

Injection of bupivacaine into the surgical incision prior to its closure.

Also known as: Bupivacaine wound infiltration

Bupivacaine; Bupivacaine and Dexmedetomidine

Dexmedetomidine DRUG

Injection of dexmedetomidine ( an adjuvant) into the surgical incision prior to its closure.

Also known as: Dexmedetomidine wound infiltration

Bupivacaine and Dexmedetomidine

Placebo DRUG

Injection of a placebo into the surgical wound

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All scheduled Cesarean deliveries with intrathecal or epidural anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Richmond University Medical Center: lead

Study Sites (1)

Richmond University Medical Center

Staten Island, New York, 10310, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nisha Lakhi, MD

  Richmond University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nisha Lakhi, MD

CONTACT

718-818-2109; NLAKHI@RUMCSI.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: June 4, 2018
• Study Start: September 17, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)