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Trial · Interventional

RecruitingPhase 2Registry data

Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy

NCTNCT06483659 (opens ClinicalTrials.gov in a new tab)Other id2024P001376
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
152 participants (estimated)
Sponsor
Brigham and Women's Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
1 Jun 2025
Primary completion
31 Dec 2027 (estimated)
Completion
30 Jun 2028 (estimated)
First posted
3 Jul 2024
Last update posted
13 Aug 2026
Conditions
Postoperative Pain

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026202720282029
  1. Ph 2

    Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy

    NCT06483659

    1 Jun 2025 to est. 30 Jun 2028

Registry summary

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

This is a randomized, double-blinded, placebo-controlled trial to compare the effectiveness of IV oxytocin infusion to placebo on peri-operative opioid consumption and reducing post-operative pain following a minimally invasive hysterectomy under general anesthesia.

Interventions

  • OxytocinDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Medication

    one group will receive Oxytocin infusion: 30 IU in 500 ml of 0.9% normal saline .

  • Placebo comparator

    Placebo

    one group will receive 500 ml of 0.9% normal saline

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Post-operative pain

    Time frame · Between 2-4 hours after surgery completion (in the PACU)

    Registry description

    Assess the impact of a perioperative infusion of oxytocin on postoperative pain, the average patient pain scores measured as a mean Brief Pain Inventory in PACU after laparoscopic hysterectomy in treated and untreated groups will be compared

Secondary outcomes(14)

  1. Perioperative opioid consumption

    Time frame · From start of infusion until approximately 6 hour mark (infusion completion)

    Registry description

    Compare the impact of a perioperative infusion of oxytocin on perioperative opioid consumption, by comparing the average in perioperative opioids (OMEs)

  2. POD1 Opioid consumption

    Time frame · In the first 24 hours after surgery

    Registry description

    Compare the impact of a perioperative infusion of oxytocin on perioperative opioid consumption, by comparing the average in perioperative opioids (OMEs)

  3. POD2 Opioid consumption

    Time frame · From 24-48 hours after surgery

    Registry description

    Compare the impact of a perioperative infusion of oxytocin on perioperative opioid consumption, by comparing the average in perioperative opioids (OMEs)

  4. POD3 Opioid consumption

    Time frame · From 48-72 hours after surgery

    Registry description

    Compare the impact of a perioperative infusion of oxytocin on perioperative opioid consumption, by comparing the average in perioperative opioids (OMEs)

  5. PACU satisfaction scores

    Time frame · Between 2-4 hours after surgery completion (in the PACU)

    Registry description

    Compare patient postoperative satisfaction scores on an 11 -point Numerical Rating Scale (with 0 being no pain and 10 being worst pain imaginable) between groups

  6. POD1 satisfaction scores

    Time frame · On Post-operative day 1

    Registry description

    Compare patient postoperative satisfaction scores on an 11 -point Numerical Rating Scale (with 0 being no pain and 10 being worst pain imaginable) between groups

  7. POD2 satisfaction scores

    Time frame · On Post-operative day 2

    Registry description

    Compare patient postoperative satisfaction scores on an 11 -point Numerical Rating Scale (with 0 being no pain and 10 being worst pain imaginable) between groups

  8. POD3 satisfaction scores

    Time frame · On Post-operative day 3

    Registry description

    Compare patient postoperative satisfaction scores on an 11 -point Numerical Rating Scale between groups

  9. PACU Post-operative pain

    Time frame · Between 2-4 hours after surgery completion (in the PACU)

    Registry description

    Compare average patient pain scores measured as a mean Brief Pain Inventory (an 11 -point Numerical Rating Scale (with 0 being no pain and 10 being worst pain imaginable)) in PACU after laparoscopic hysterectomy in treated and untreated groups

  10. POD1 Post-operative pain

    Time frame · On Post-operative day 1

    Registry description

    Compare average patient pain scores measured as a mean Brief Pain Inventory (an 11 -point Numerical Rating Scale (with 0 being no pain and 10 being worst pain imaginable)) on POD1 in treated and untreated groups

  11. POD2 Post-operative pain

    Time frame · On Post-operative day 2

    Registry description

    Compare average patient pain scores measured as a mean Brief Pain Inventory (an 11 -point Numerical Rating Scale (with 0 being no pain and 10 being worst pain imaginable)) on POD2 in treated and untreated groups

  12. POD3 Post-operative pain

    Time frame · On Post-operative day 3

    Registry description

    Compare average patient pain scores measured as a mean Brief Pain Inventory (an 11 -point Numerical Rating Scale (with 0 being no pain and 10 being worst pain imaginable)) on POD3 in treated and untreated groups

  13. Intraoperative hypotension (# of episodes of MAP <60 mmHg)

    Time frame · Through surgery completion, an average of 2 hours (From start of infusion to completion end of time in the operating room)

    Registry description

    Assess the impact of a perioperative infusion of oxytocin on hypotension

  14. PACU hypotension (# of episodes of MAP <60 mmHg)

    Time frame · Between 0-4 hours after surgery completion (in the PACU)

    Registry description

    Assess the impact of a perioperative infusion of oxytocin on hypotension

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

Studies11

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 pageSee 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 pageSee results (1)

More studies

8 studies on this page

PubMed tag: none · 2019

Association of Interindividual Variation in Plasma Oxytocin With Postcesarean Incisional Pain.

Ende et al. 2019Anesthesia and analgesiacited by 5

PMID 29916862DOI 10.1213/ane.0000000000003567PUB-29916862

Full text at the publisher
Publisher page

PubMed tag: none · 2019

International consensus statement on the use of uterotonic agents during caesarean section.

Heesen et al. 2019Anaesthesiacited by 113

PMID 31347151DOI 10.1111/anae.14757PUB-31347151

Full text at the publisher
Publisher page

Indexing hint: Review · 2016

Relationship Between Oxytocin and Pain Modulation and Inflammation.

Matsuura et al. 2016Journal of UOEHcited by 10

PMID 27980316DOI 10.7888/juoeh.38.325PUB-27980316

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2015

A Randomized, Double-blinded Trial of a "Rule of Threes" Algorithm versus Continuous Infusion of Oxytocin during Elective Cesarean Delivery.

Kovacheva et al. 2015Anesthesiologycited by 42

PMID 25909969DOI 10.1097/aln.0000000000000682PUB-25909969

Full text at the publisher
Publisher 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
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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
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Ages 18-65 years old * ASA category 1-3 * Scheduled to undergo minimally invasive hysterectomy * No documented allergy to oxytocin Exclusion Criteria: * American Society of Anesthesiologists (ASA) group 4 or greater * Age \>65 years old * Additional surgical procedures including but not limited to minor laparotomy, omentectomy, cystectomy, vaginectomy, and/or ablation of endometriosis. * Active opioid prescription of the equivalent of oxycodone \>10 mg /day * Opioid use disorder, including patients in treatment receiving naltrexone or Suboxone (Buprenorphine-naloxone) * Allergies to any study medication: acetaminophen, celecoxib, ketorolac, fentanyl, hydromorphone, or oxycodone. * Epidural/Regional anesthesia for intra-operative or post-operative pain. * Inability to understand the questionnaires * Intra-operative and post-operative exclusion: Procedure converted to open or extension of primary surgery, Intra-operative EBL \>500 ml., Placement of epidural catheter or regional anesthesia at PACU for pain management, Hospitalization of the patient due to surgical or anesthetic complications

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