Trial · Interventional

WithdrawnPhase 4Registry data

IV Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy

NCTNCT05608070Other id2022P000895

Open at ClinicalTrials.govAsk about this trial

This trial was withdrawn before it enrolled anyone.

Reason given at the registry: Sponsor declined to fund

Overview

Status: Withdrawn
Phase: Phase 4
Enrollment: 0 participants (actual)
Sponsor: Beth Israel Deaconess Medical Center · Other
Design: Randomized · Quadruple masking
Countries: Not stated
Start: 1 Jun 2023
Primary completion: Jun 2024 (estimated)
Completion: Jun 2025 (estimated)
First posted: 8 Nov 2022
Last update posted: 14 Aug 2023
Conditions: Pain, Postoperative · Analgesia · Postoperative Pain · Pain, Post Operative · Oxytocin

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2023202420252026

Ph 4
IV Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
NCT05608070
1 Jun 2023 to est. Jun 2025
Withdrawn
Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This double-blinded, placebo-control trial clinical trial aims to investigate the effect of IV oxytocin infusion on peri-operative opioid consumption following a minimally invasive hysterectomy under general anesthesia. The patient population will be women scheduled for an elective, minimally invasive hysterectomy at Beth Israel Deaconess Medical Center. The investigators hypothesize that, compared to a placebo, exposure to intravenous (IV) oxytocin will reduce the amount of opioid consumption for women after a minimally invasive hysterectomy procedure.

Interventions

OxytocinDrug
PlaceboDrug

Arms2

Experimental
IV Oxytocin
Placebo comparator
Placebo- NaCl 0.9%

Primary outcomes1

Outcomes the sponsor listed as primary.

Total opioids consumption
Time frame · 3 days
Registry description
Average Opioid Oral Morphine Milligram Equivalent (MME) during intra-operative and post-operative period

Secondary outcomes(5)

Post Operative Pain scores
Time frame · 2 days
Registry description
11-point (0-10) pain scores on Numerical Rating Scale (NRS) in Post Anesthesia Care Unit (PACU), Post-Operative Day (POD) 0 and POD1.
Anxiety score
Time frame · 3 days
Registry description
State-Trait Anxiety Inventory (STAI-6)
Quality of Recovery Score
Time frame · 3 days
Registry description
Postoperative Quality of Recovery Score (QoR-15)
Catastrophizing Scale
Time frame · 3 days
Registry description
Daily Pain Catastrophizing Scale (DPCS)
Patient-rated Satisfaction
Time frame · 1 day
Registry description
11-point (0-10) patient satisfaction scores on Numerical Rating Scale (NRS) in PACU and POD0

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2021

Anti-nociceptive effects of oxytocin receptor modulation in healthy volunteers-A randomized, double-blinded, placebo-controlled study.

Biurrun Manresa et al. 2021European journal of pain (London, England)cited by 9

PMID 33884702DOI 10.1002/ejp.1781PUB-33884702

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 1994

11 results

Intrathecal administration of oxytocin induces analgesia in low back pain involving the endogenous opiate peptide system.

Yang et al. 1994Spinecited by 125

PMID 8009342DOI 10.1097/00007632-199404150-00001PUB-08009342

Full text at the publisher11 results

Publisher page See results (11)

Indexing hint: Case report · 1987

1 result

Intraventricular somatostatin-14, arginine vasopressin, and oxytocin: analgesic effect in a patient with intractable cancer pain.

Madrazo et al. 1987Applied neurophysiologycited by 71

PMID 2897190DOI 10.1159/000100753PUB-02897190

Full text at the publisher1 result

Publisher page See results (1)

More studies

4 studies on this page

Indexing hint: Review · 2015

Oxytocin and vasopressin: linking pituitary neuropeptides and their receptors to social neurocircuits.

Baribeau et al. 2015Frontiers in neurosciencecited by 154

PMID 26441508PMC4585313DOI 10.3389/fnins.2015.00335PUB-26441508

CC BY

Download PDF

Indexing hint: Animal study · 2006

Oxytocin and electrical stimulation of the paraventricular hypothalamic nucleus produce antinociceptive effects that are reversed by an oxytocin antagonist.

Miranda-Cardenas et al. 2006Paincited by 103

PMID 16527400DOI 10.1016/j.pain.2006.01.029PUB-16527400

Full text at the publisher

Publisher page

Indexing hint: Review · 2001

The oxytocin receptor system: structure, function, and regulation.

Gimpl et al. 2001Physiological reviewscited by 2,174

PMID 11274341DOI 10.1152/physrev.2001.81.2.629PUB-11274341

Full text at the publisher

Publisher page

Indexing hint: Animal study · 1994

Anti-nociceptive effects of oxytocin in rats and mice.

Lundeberg et al. 1994Neuroscience letterscited by 110

PMID 8041495DOI 10.1016/0304-3940(94)90262-3PUB-08041495

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Women the age of 18-65 years old undergoing elective, minimally invasive hysterectomy under general anesthesia Exclusion Criteria: * American Society of Anesthesiology (ASA) Physical Status Classification System Score of 4 or greater * Additional surgical components including but not limited to: minor laparotomy, omentectomy, cystectomy, and lymph node dissection. * Allergies to any study medication: acetaminophen, ketorolac, hydromorphone, oxycodone, fentanyl, gabapentin, pregabalin. * Epidural/Regional anesthesia used for intra-operative or post-operative pain.

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