IV Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy

NCT05608070 | Withdrawn Phase 4

• 1 other identifier: 2022P000895
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain, Postoperative; Analgesia; Postoperative Pain; Pain, Post Operative; Oxytocin

Keywords

Postoperative pain; Oxytocin; Non-opioid analgesia; Multimodal analgesia; Female; Humans

Outcome Measures

Primary Outcomes (1)

• Total opioids consumption

  Average Opioid Oral Morphine Milligram Equivalent (MME) during intra-operative and post-operative period

  3 days

Secondary Outcomes (5)

• Post Operative Pain scores

  2 days

• Anxiety score

  3 days

• Quality of Recovery Score

  3 days

• Catastrophizing Scale

  3 days

• Patient-rated Satisfaction

  1 day

Study Arms (2)

IV Oxytocin

EXPERIMENTAL

Drug: Oxytocin

Placebo- NaCl 0.9%

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oxytocin DRUG

Oxytocin 30 IU in 500 ml IV at a rate of 5 IU/h (83.33 ml/h). The infusion will be started intra-operative once the uterus is removed and will continue to run until completion of the medication or discharge from PACU criteria are met, whichever occurs first.

Also known as: Pitocin

IV Oxytocin

Placebo DRUG

0.9% saline infusion at the rate of 83.3 ml/h.

Also known as: 0.9% NaCl, Saline

Placebo- NaCl 0.9%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women the age of 18-65 years old undergoing elective, minimally invasive hysterectomy under general anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Related Publications (10)

• Soffin EM, Lee BH, Kumar KK, Wu CL. The prescription opioid crisis: role of the anaesthesiologist in reducing opioid use and misuse. Br J Anaesth. 2019 Jun;122(6):e198-e208. doi: 10.1016/j.bja.2018.11.019. Epub 2018 Dec 28.

  PMID: 30915988 BACKGROUND

• Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.

  PMID: 28403427 BACKGROUND

• Bae S, Alboog A, Esquivel KS, Abbasi A, Zhou J, Chui J. Efficacy of perioperative pharmacological and regional pain interventions in adult spine surgery: a network meta-analysis and systematic review of randomised controlled trials. Br J Anaesth. 2022 Jan;128(1):98-117. doi: 10.1016/j.bja.2021.08.034. Epub 2021 Nov 10.

  PMID: 34774296 BACKGROUND

• Lundeberg T, Uvnas-Moberg K, Agren G, Bruzelius G. Anti-nociceptive effects of oxytocin in rats and mice. Neurosci Lett. 1994 Mar 28;170(1):153-7. doi: 10.1016/0304-3940(94)90262-3.

  PMID: 8041495 BACKGROUND

• Biurrun Manresa JA, Schliessbach J, Vuilleumier PH, Muller M, Musshoff F, Stamer U, Stuber F, Arendt-Nielsen L, Curatolo M. Anti-nociceptive effects of oxytocin receptor modulation in healthy volunteers-A randomized, double-blinded, placebo-controlled study. Eur J Pain. 2021 Sep;25(8):1723-1738. doi: 10.1002/ejp.1781. Epub 2021 May 3.

  PMID: 33884702 BACKGROUND

• Gimpl G, Fahrenholz F. The oxytocin receptor system: structure, function, and regulation. Physiol Rev. 2001 Apr;81(2):629-83. doi: 10.1152/physrev.2001.81.2.629.

  PMID: 11274341 BACKGROUND

• Baribeau DA, Anagnostou E. Oxytocin and vasopressin: linking pituitary neuropeptides and their receptors to social neurocircuits. Front Neurosci. 2015 Sep 24;9:335. doi: 10.3389/fnins.2015.00335. eCollection 2015.

  PMID: 26441508 BACKGROUND

• Miranda-Cardenas Y, Rojas-Piloni G, Martinez-Lorenzana G, Rodriguez-Jimenez J, Lopez-Hidalgo M, Freund-Mercier MJ, Condes-Lara M. Oxytocin and electrical stimulation of the paraventricular hypothalamic nucleus produce antinociceptive effects that are reversed by an oxytocin antagonist. Pain. 2006 May;122(1-2):182-9. doi: 10.1016/j.pain.2006.01.029. Epub 2006 Mar 9.

  PMID: 16527400 BACKGROUND

• Madrazo I, Franco-Bourland RE, Leon-Meza VM, Mena I. Intraventricular somatostatin-14, arginine vasopressin, and oxytocin: analgesic effect in a patient with intractable cancer pain. Appl Neurophysiol. 1987;50(1-6):427-31. doi: 10.1159/000100753.

  PMID: 2897190 BACKGROUND

• Yang J. Intrathecal administration of oxytocin induces analgesia in low back pain involving the endogenous opiate peptide system. Spine (Phila Pa 1976). 1994 Apr 15;19(8):867-71. doi: 10.1097/00007632-199404150-00001.

  PMID: 8009342 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Oxytocin; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• John J. Kowalczyk, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Shiri Savir, MD MPH

  Beth Israel Deaconess Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding will be performed by the Investigational Research Pharmacy. The Investigational Research Pharmacy will have the randomization key and prepare medication or placebo. The study medication or placebo in 500 ml bag of labeled as "Oxytocin Study Drug for IV infusion".
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Compliance Officer

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share