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

Primary Purpose

Pain, Postoperative, Anesthesia, Local, Opioid Use

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Bupivacaine

Dexmedetomidine

Placebo

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Wound infiltration, Post Cesarean, Pain management, bupivacaine, dexmedetomidine, postoperative pain

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Richmond University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Bupivacaine

Bupivacaine and Dexmedetomidine

Arm Description

Wound infiltration with a placebo

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

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 .

Outcomes

Primary Outcome Measures

Total number of opioid free Cesarean deliveries

Measure the number of Cesarean deliveries that did not require opioid analgesia during the postoperative course

Secondary Outcome Measures

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

Total opioid consumption

Measure the subjects total opioid consumption for the total duration of the postoperative course.

Side effects/Adverse reactions

Measure any side effects/allergic reactions attributed to use of any of the study drugs.

Postoperative hospital stay

Measure the length of the post-operative hospital stay .

Complications from procedures

Measure any complications associated with the wound infiltration procedure

Breast feeding capacity

Assess the subject's capacity to breast feed during the postoperative course

Full Information

NCT ID

NCT03545516

First Posted

March 22, 2018

Last Updated

August 28, 2018

Sponsor

Richmond University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03545516

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 17, 2018 (Anticipated)

Primary Completion Date

November 1, 2018 (Anticipated)

Study Completion Date

November 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Richmond University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Anesthesia, Local, Opioid Use

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Wound infiltration with a placebo

Arm Title

Bupivacaine

Arm Type

Experimental

Arm Description

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

Arm Title

Bupivacaine and Dexmedetomidine

Arm Type

Experimental

Arm Description

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 .

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

Bupivacaine wound infiltration

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

Dexmedetomidine wound infiltration

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Injection of a placebo into the surgical wound

Primary Outcome Measure Information:

Title

Total number of opioid free Cesarean deliveries

Description

Measure the number of Cesarean deliveries that did not require opioid analgesia during the postoperative course

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Time to first rescue analgesia

Description

Measure the time to first rescue analgesia from immediate post operative (0 hour) till when the rescue analgesia is administered

Time Frame

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

Title

Total opioid consumption

Description

Measure the subjects total opioid consumption for the total duration of the postoperative course.

Time Frame

0-14 days

Title

Side effects/Adverse reactions

Description

Measure any side effects/allergic reactions attributed to use of any of the study drugs.

Time Frame

0-14 days

Title

Postoperative hospital stay

Description

Measure the length of the post-operative hospital stay .

Time Frame

0-14days

Title

Complications from procedures

Description

Measure any complications associated with the wound infiltration procedure

Time Frame

0-14 days

Title

Breast feeding capacity

Description

Assess the subject's capacity to breast feed during the postoperative course

Time Frame

0-14 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nisha Lakhi, MD

Phone

718-818-2109

NLAKHI@RUMCSI.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nisha Lakhi, MD

Organizational Affiliation

Richmond University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Richmond University Medical Center

City

Staten Island

State/Province

New York

ZIP/Postal Code

10310

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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