Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy

NCT06483659 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2024P001376
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

  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

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

Secondary Outcomes (14)

• Perioperative opioid consumption

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

• POD1 Opioid consumption

  In the first 24 hours after surgery

• POD2 Opioid consumption

  From 24-48 hours after surgery

• POD3 Opioid consumption

  From 48-72 hours after surgery

• PACU satisfaction scores

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

Study Arms (2)

Medication

ACTIVE COMPARATOR

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

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

one group will receive 500 ml of 0.9% normal saline

Drug: Placebo

Interventions

Oxytocin DRUG

Intravenous Oxytocin infusion

Also known as: Pitocin

Medication

Placebo DRUG

0.9% Saline

Also known as: Normal Saline, 0.9% Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-65 years old
• ASA category 1-3
• Scheduled to undergo minimally invasive hysterectomy
• No documented allergy to oxytocin

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (15)

• 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.

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• 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.

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• 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

• Matsuura T, Motojima Y, Kawasaki M, Ohnishi H, Sakai A, Ueta Y. [Relationship Between Oxytocin and Pain Modulation and Inflammation]. J UOEH. 2016;38(4):325-334. doi: 10.7888/juoeh.38.325. Japanese.

  PMID: 27980316 BACKGROUND

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  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

• 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

• 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

• Ende HB, Soens MA, Nandi M, Strichartz GR, Schreiber KL. Association of Interindividual Variation in Plasma Oxytocin With Postcesarean Incisional Pain. Anesth Analg. 2019 Oct;129(4):e118-e121. doi: 10.1213/ANE.0000000000003567.

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• ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.

  PMID: 19623003 BACKGROUND

• Kovacheva VP, Soens MA, Tsen LC. A Randomized, Double-blinded Trial of a "Rule of Threes" Algorithm versus Continuous Infusion of Oxytocin during Elective Cesarean Delivery. Anesthesiology. 2015 Jul;123(1):92-100. doi: 10.1097/ALN.0000000000000682.

  PMID: 25909969 BACKGROUND

• Heesen M, Carvalho B, Carvalho JCA, Duvekot JJ, Dyer RA, Lucas DN, McDonnell N, Orbach-Zinger S, Kinsella SM. International consensus statement on the use of uterotonic agents during caesarean section. Anaesthesia. 2019 Oct;74(10):1305-1319. doi: 10.1111/anae.14757. Epub 2019 Jul 25.

  PMID: 31347151 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxytocin; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

John J. Kowalczyk, MD

CONTACT

617-732-8220; jkowalczyk@bwh.harvard.edu

Rusul I Al-Ani

CONTACT

617-525-6483; rual-ani@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization of the study medication will be performed by the investigational drug pharmacy and the unblinded key will be stored in a secure location in the pharmacy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Fellowship Research

Model Details: 152 study subjects who are having minimally invasive abdominal hysterectomy will be randomized into one of two treatment groups, the first group will receive Oxytocin I.V. infusion and the second group will receive Saline infusion, and both groups will be followed up with surveys for up to 3 months after surgery.

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: July 3, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)