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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03545516
Recruitment Status : Not yet recruiting
First Posted : June 4, 2018
Last Update Posted : August 29, 2018
Information provided by (Responsible Party):
Nisha Lakhi, MD, Richmond University Medical Center

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Anesthesia, Local Opioid Use Drug: Bupivacaine Drug: Dexmedetomidine Drug: Placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Control Trial for an Opioid Free Analgesic Pathway Post Cesarean Delivery
Estimated Study Start Date : September 17, 2018
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : November 1, 2018

Arm Intervention/treatment
Placebo Comparator: Placebo
Wound infiltration with a placebo
Drug: Placebo
Injection of a placebo into the surgical wound

Experimental: Bupivacaine
Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine diluted with 5 mL of normal saline to give a 25 mL
Drug: Bupivacaine
Injection of bupivacaine into the surgical incision prior to its closure.
Other Name: Bupivacaine wound infiltration

Experimental: Bupivacaine and Dexmedetomidine
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
Injection of bupivacaine into the surgical incision prior to its closure.
Other Name: Bupivacaine wound infiltration

Drug: Dexmedetomidine
Injection of dexmedetomidine ( an adjuvant) into the surgical incision prior to its closure.
Other Name: Dexmedetomidine wound infiltration

Primary Outcome Measures :
  1. Total number of opioid free Cesarean deliveries [ Time Frame: 1 year ]
    Measure the number of Cesarean deliveries that did not require opioid analgesia during the postoperative course

Secondary Outcome Measures :
  1. Time to first rescue analgesia [ Time Frame: 0 hour post-cesarean to time rescue analgeisa is administered] ]
    Measure the time to first rescue analgesia from immediate post operative (0 hour) till when the rescue analgesia is administered

  2. Total opioid consumption [ Time Frame: 0-14 days ]
    Measure the subjects total opioid consumption for the total duration of the postoperative course.

  3. Side effects/Adverse reactions [ Time Frame: 0-14 days ]
    Measure any side effects/allergic reactions attributed to use of any of the study drugs.

  4. Postoperative hospital stay [ Time Frame: 0-14days ]
    Measure the length of the post-operative hospital stay .

  5. Complications from procedures [ Time Frame: 0-14 days ]
    Measure any complications associated with the wound infiltration procedure

  6. Breast feeding capacity [ Time Frame: 0-14 days ]
    Assess the subject's capacity to breast feed during the postoperative course

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03545516

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Contact: Nisha Lakhi, MD 718-818-2109

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United States, New York
Richmond University Medical Center
Staten Island, New York, United States, 10310
Sponsors and Collaborators
Richmond University Medical Center
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Principal Investigator: Nisha Lakhi, MD Richmond University Medical Center

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Responsible Party: Nisha Lakhi, MD, Research Director, Richmond University Medical Center Identifier: NCT03545516     History of Changes
Other Study ID Numbers: Post Cesarean Pain Management
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Nisha Lakhi, MD, Richmond University Medical Center:
Wound infiltration
Post Cesarean
Pain management
postoperative pain

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action