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Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction

Primary Purpose

Oocyte Retrieval, Postoperative Pain

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fentanyl
Acetaminophen
Oxycodone
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oocyte Retrieval focused on measuring assisted reproduction, postoperative pain, opioid

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) I to III health status (moderate systemic disease),
  • Age between 18 and 50 yrs
  • Undergoing oocyte retrieval with intravenous general anesthesia.

Exclusion Criteria:

  • Refuse or withdraw their consent
  • Fail to adequately respond to IVF stimulations medications, and thus are not eligible for oocyte retrieval.

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Analgesia options

Arm Description

Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.

Outcomes

Primary Outcome Measures

Amount of Discomfort
Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale). VAS scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort.

Secondary Outcome Measures

Amount of Discomfort Following Discharge Until Embryo Transfer
Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale) after immediate postoperative period (1 hrs) but prior to Embryo Transfer on 3rd postoperative day. Visual Analogue Scale (VAS) scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort. Patients will record the type, dose, and timing of pain medicines in a diary to be returned at Embryo Transfer.

Full Information

First Posted
October 5, 2014
Last Updated
August 2, 2022
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03105518
Brief Title
Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction
Official Title
Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2011 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The central objective of this study will be to evaluate the relationship between estrogen levels and the pain following oocyte retrieval in women undergoing in vitro fertilization.
Detailed Description
Subject will undergo standard clinical protocols for the entire oocyte stimulation cycle and all assisted reproductive procedure decisions and algorithms will be decided entirely independent of this study. The anesthetic and postoperative pain regimens will use the same agents and dose ranges used in clinical standard practice; however, the regimens will be standardized, so as to limit confounding variables. The study regimen for anesthesia will differ from the current, clinical standard by the mandated use of actual body weight (in current practice, actual, adjusted ideal, or ideal body weights are used), the use of fentanyl 1 mcg/kg IV (instead of 100 mcg for everyone), and the standardization of postoperative analgesia (noted below). The total amount of fentanyl, propofol, and postoperative drugs will be recorded. Postoperative analgesia will be standardized based on the subject's self reported verbal analogue score (VAS) and the timing of the report. The agents and timing used below differ from the current clinical standard by assessing VAS and responding with a certain regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oocyte Retrieval, Postoperative Pain
Keywords
assisted reproduction, postoperative pain, opioid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Assessment of immediate and delayed postoperative pain
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Analgesia options
Arm Type
Experimental
Arm Description
Protocolized analgesia based on VAS degree of discomfort and time. Analgesic options include heating pad, acetaminophen, percocet (oxycodone), fentanyl 0.5-1 mcg/kg.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Sublimaze
Intervention Description
0.5, 1 mcg/kg
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
Single + Oxycodone
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
Percocet
Intervention Description
With Acetaminophen
Primary Outcome Measure Information:
Title
Amount of Discomfort
Description
Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale). VAS scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort.
Time Frame
PACU admission, 15, 30 and 60 min postprocedure, postoperative day 3
Secondary Outcome Measure Information:
Title
Amount of Discomfort Following Discharge Until Embryo Transfer
Description
Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale) after immediate postoperative period (1 hrs) but prior to Embryo Transfer on 3rd postoperative day. Visual Analogue Scale (VAS) scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort. Patients will record the type, dose, and timing of pain medicines in a diary to be returned at Embryo Transfer.
Time Frame
After 1 hrs but less than 3 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) I to III health status (moderate systemic disease), Age between 18 and 50 yrs Undergoing oocyte retrieval with intravenous general anesthesia. Exclusion Criteria: Refuse or withdraw their consent Fail to adequately respond to IVF stimulations medications, and thus are not eligible for oocyte retrieval.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence C Tsen, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12351295
Citation
Harnett MJ, Bhavani-Shankar K, Datta S, Tsen LC. In vitro fertilization-induced alterations in coagulation and fibrinolysis as measured by thromboelastography. Anesth Analg. 2002 Oct;95(4):1063-6, table of contents. doi: 10.1097/00000539-200210000-00050.
Results Reference
result
PubMed Identifier
2221417
Citation
Bader AM, Datta S, Moller RA, Covino BG. Acute progesterone treatment has no effect on bupivacaine-induced conduction blockade in the isolated rabbit vagus nerve. Anesth Analg. 1990 Nov;71(5):545-8. doi: 10.1213/00000539-199011000-00016.
Results Reference
result
PubMed Identifier
6650889
Citation
Datta S, Lambert DH, Gregus J, Gissen AJ, Covino BG. Differential sensitivities of mammalian nerve fibers during pregnancy. Anesth Analg. 1983 Dec;62(12):1070-2.
Results Reference
result

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Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction

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