The Effects of One-time Intraoperative Methadone During Laparoscopic Hysterectomy in Reducing Opioid Prescription.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJohns Hopkins University

About this trial

Currently, there is a nationwide epidemic of opioid abuse and overdose deaths. One source of excess opioids is overprescribing in the postoperative period. This study aims to find the optimal pain medication plan during and after laparoscopic hysterectomy to eliminate long-term opioid use.

Given the increasing opioid abuse and over-prescription post-operatively, an effort should be made to determine whether one time dosing of Methadone, a longer opioid analgesics, intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries. The investigators hypothesize that this could minimize the need for additional post-operative and outpatient opioid prescriptions and decrease the adverse effects that are associated with the consumption, including new opioid abuse.

Intervention group will receive methadone intraoperatively while the other group would receive short-acting opioids (standard).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals with a uterus

Age 18 years old and above

Undergoing minimally invasive (laparoscopic or robotic) hysterectomy with ovarian preservation

Benign indications for hysterectomy

Disqualifiers

Chronic pain syndromes patients including fibromyalgia

Patients currently on long-term (i.e. for more than three months) opioid use

Patients currently on agonist-antagonist medications (e.g. buprenorphine)

Patients taking a selective serotonin reuptake inhibitor or monoamine oxidase inhibitor

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methadone

    Drug

    Intra-operative single dose IV Methadone (0.25 mg/kg of ideal body weight)

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: MethadoneExperimental treatment 1 intervention
Group B: Short-Acting OpioidOther 1 intervention

Trial outcomes

Primary outcomes

1

Total post-operative opioid requirements in oral morphine milligram equivalents (MME)

Total post-operative opioid requirements in oral morphine milligram equivalents (MME) in first 7 post operative days.

Time frame
1 week

Secondary outcomes

1

Mobility and satisfaction of analgesia

Mobility and satisfaction of analgesia on post-operative day one and seven (binary question Y/N)

Time frame
Post operative day 1, Post operative day 7
2

Number of unplanned returns to emergency room/clinic or patient initiated phone call regarding pain

Time frame
1 week
3

Overall satisfaction with pain control

0-10 scale (0- no pain, 10-worst pain)

Time frame
1 week

Other outcomes

Sponsors and contacts

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