Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval

Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval: a Randomized, Double Blind, Placebo-controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03073980

Enrollment

161

Registered

2017-03-08

Start date

2019-09-01

Completion date

2020-12-01

Last updated

2022-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female, Pain, Postoperative

Keywords

in vitro fertilization, oocyte retrieval, acetaminophen, postoperative pain control

Brief summary

In this research study we want to learn more about how effective certain medications are at reducing pain after oocyte (egg) retrieval surgery and how effective they are at reducing the time between the retrieval and discharge from the hospital. We will compare three types of pre-operative medications: intravenous (IV) acetaminophen, oral (PO) acetaminophen, and placebo (no medication), which is the current typical care.

Detailed description

OBJECTIVE: To compare the efficacy of pre-operative IV acetaminophen, PO acetaminophen, versus placebo for adjunctive pain control in the setting of oocyte retrieval in an in vitro fertilization clinic setting. HYPOTHESIS: Our hypothesis is that patients receiving IV acetaminophen pre-operatively will have improved postoperative pain scores, lower overall opiate consumption, and shortened time to discharge from post analgesic recovery unit (PACU) or recovery than those receiving PO acetaminophen or placebo. Participants will be consented and enrolled in the study prior to their oocyte retrieval. The patient will then be randomized to one of three treatments: Group 1: In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed. Group 2: In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed. Group 3: In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed. The patient and care team will be blinded to the treatment group. A member of the study staff will review participants' medical record to collect data regarding demographics, clinical history, cycle and pregnancy outcomes, up to 12 months following study completion.

Interventions

DRUGIV Acetaminophen

IV Acetaminophen for pain control during procedure

DRUGPO Acetaminophen

PO Acetaminophen for pain control during procedure

OTHERPlacebo IV Acetaminophen

Placebo IV Acetaminophen

OTHERPlacebo PO Acetaminophen

Placebo PO Acetaminophen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 44 Years

Healthy volunteers

Yes

Inclusion criteria

\[ \] Patient is 18 years or over, undergoing oocyte retrieval. \[ \] Patient is English-speaking.

Exclusion criteria

\[ \] Allergy/hypersensitivity to acetaminophen or opiates. \[ \] Any history of liver disease, history of alcohol depending, or renal impairment as reported in the electronic health record. \[ \] Any history chronic opiate use or chronic pain disorder reported in the electronic health record. \[ \] Weight less than 50kg as reported in the medical record.

Design outcomes

Primary

Measure	Time frame	Description
Post-operative Pain Score Difference 10 Mins From Pre-operative	Pain was measured pre-operatively and at 10 minutes post-procedure.	Visual analog scale of pain, ranging from 0 (no pain) to 10 (worst pain imaginable) in whole numbers. The final score is the post-operative score minus the pre-operative score.
Time to Discharge From the Post-operative Recovery Room	0-6 hours post-procedure	Discharge time was based on the nurse's assessment of patient alertness, ability to tolerate oral liquids and food, and ability to void.

Secondary

Measure	Time frame	Description
Procedure Length	0-2 hours	Duration of egg retrieval
Postoperative Nausea and Vomiting	0-2 days	One or more episodes of nausea and vomiting in the recovery room and through post-operative day 2
Oocyte Yield	0 days	The number of oocytes retrieved from the patient's ovaries as part of an in vitro-fertilization treatment. This includes both immature and mature oocytes.
Rescue Medication Required	During procedure and immediately post-operative in recovery room within 45 minutes	One or more doses of opiate pain medication given due to pain during the procedure or immediately post-operative in the recovery room.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Group A: IV Acetaminophen/PO Placebo In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed. IV Acetaminophen: IV Acetaminophen for pain control during procedure Placebo PO Acetaminophen: Placebo PO Acetaminophen	53
Group B: IV Placebo/PO Acetaminophen In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed. PO Acetaminophen: PO Acetaminophen for pain control during procedure Placebo IV Acetaminophen: Placebo IV Acetaminophen	54
Group C: IV Placebo / PO Placebo In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed. Placebo IV Acetaminophen: Placebo IV Acetaminophen Placebo PO Acetaminophen: Placebo PO Acetaminophen	52
Total	159

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	10	2	9
Overall Study	No post-procedure data	0	0	2

Baseline characteristics

Characteristic	Group C: IV Placebo / PO Placebo	Total	Group B: IV Placebo/PO Acetaminophen	Group A: IV Acetaminophen/PO Placebo
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	52 Participants	159 Participants	54 Participants	53 Participants
Age, Continuous	36.0 years STANDARD_DEVIATION 4	35.6 years STANDARD_DEVIATION 4.2	35.7 years STANDARD_DEVIATION 4.5	35.2 years STANDARD_DEVIATION 4.1
Body Mass Index (BMI)	25.6 kg/m^2 STANDARD_DEVIATION 4.9	25.3 kg/m^2 STANDARD_DEVIATION 4.6	24.9 kg/m^2 STANDARD_DEVIATION 4.1	25.4 kg/m^2 STANDARD_DEVIATION 4.7
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	8 Participants	1 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants	7 Participants	3 Participants	2 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	46 Participants	144 Participants	50 Participants	48 Participants
Number of Nulliparous Participants	43 Participants	123 Participants	39 Participants	41 Participants
Ovarian reserve (anti-mullerian hormone)	2.4 ng/ml STANDARD_DEVIATION 1.7	2.8 ng/ml STANDARD_DEVIATION 2.3	3.0 ng/ml STANDARD_DEVIATION 2.4	2.9 ng/ml STANDARD_DEVIATION 2.9
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	6 Participants	15 Participants	4 Participants	5 Participants
Race (NIH/OMB) Black or African American	1 Participants	5 Participants	2 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants	16 Participants	5 Participants	5 Participants
Race (NIH/OMB) White	39 Participants	123 Participants	43 Participants	41 Participants
Region of Enrollment United States	52 participants	159 participants	54 participants	53 participants
Sex: Female, Male Female	52 Participants	159 Participants	54 Participants	53 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 53	0 / 54	0 / 54
other Total, other adverse events	0 / 53	0 / 54	0 / 54
serious Total, serious adverse events	0 / 53	0 / 54	0 / 54

Outcome results

Primary

Post-operative Pain Score Difference 10 Mins From Pre-operative

Visual analog scale of pain, ranging from 0 (no pain) to 10 (worst pain imaginable) in whole numbers. The final score is the post-operative score minus the pre-operative score.

Time frame: Pain was measured pre-operatively and at 10 minutes post-procedure.

Population: Post-operative pain score - pre-operative pain score; 2 patients in group 3 had egg retrieval cancelled due to Coronavirus Disease (COVID); data could not be collected in these patients, yet their enrollment was included in an intention-to-treat analysis.

Arm	Measure	Value (MEAN)	Dispersion
Group 1: IV Acetaminophen/PO Placebo	Post-operative Pain Score Difference 10 Mins From Pre-operative	1.3 score on a scale	Standard Deviation 2.4
Group 2: IV Placebo/PO Acetaminophen	Post-operative Pain Score Difference 10 Mins From Pre-operative	1.3 score on a scale	Standard Deviation 2.8
Group 3: IV Placebo/PO Placebo	Post-operative Pain Score Difference 10 Mins From Pre-operative	1.8 score on a scale	Standard Deviation 1.8

Primary

Time to Discharge From the Post-operative Recovery Room

Discharge time was based on the nurse's assessment of patient alertness, ability to tolerate oral liquids and food, and ability to void.

Time frame: 0-6 hours post-procedure