Postoperative PainPhase 2NCT06483659
Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
A Phase 2 study testing Oxytocin in people with Postoperative Pain, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-65 years old
- ASA category 1-3
- Scheduled to undergo minimally invasive hysterectomy
- No documented allergy to oxytocin
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
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.
Read the detailed description
152 women will be randomized into one of two arms; participants in the first arm (Intervention) will receive oxytocin infusion, 30 IU in 500 ml IV infusion at a rate of 5 IU/h (83.33 ml/h), the second arm (Control) will receive 0.9% normal saline 500 ml IV infusion at the same rate of 83.3 ml/h. The primary care team (anesthesia, surgery, and nursing), the research team, and the patient will all be blinded to the research arm.
The investigational research pharmacy will perform randomization; participants will be randomized in a 1:1 ratio to receive either Oxytocin or Placebo (0.9% normal saline). Randomization will be blinded to investigators to prevent bias and ensure balance in treatment arms throughout the study. Participants, surgeons, clinicians, and raters will be blinded with respect to treatment assignments. The investigational pharmacy will prepare the study drug based on the randomization assignment received.
The investigators will identify patients who have been scheduled for an elective, minimally invasive hysterectomy at Brigham and Women's Hospital by reviewing the operating room booking schedule.
Patients will be pre-screened for inclusion and exclusion criteria. Subsequently, they will be recruited for participation in this study by phone/ MGB Zoom and will be consented by electronic consent.
Once the patient is recruited and consented, they will be randomized for either the intervention group (oxytocin IV infusion) or the control group (0.9% normal saline IV infusion).
An email will be sent to those who consent with a link to the secure REDCap system containing a set of baseline questionnaires to assess relevant medical and surgical history, pre-operative pain, analgesic medication use, and psychosocial variables.
Both groups (intervention and control) will be treated pre-operatively with the following Early Recovery After Surgery (ERAS) medications, as per usual institutional practice:
- acetaminophen 1,000 mg orally
- celecoxib 400 mg orally The Investigational Research Pharmacy will be informed and prepare blinded infusions for perioperative administration (oxytocin or placebo).
The primary anesthesiology team will receive either the study medication or placebo in a 500 ml bag labeled as "Oxytocin Study Drug for IV infusion".
A recommended "Intra-Operative Analgesia Management" algorithm will be given to the primary anesthetic team. The recommended algorithm for intra-operative analgesia management will include the following:
- Fentanyl 100 mcg IV for induction.
- Dexamethasone 8 mg IV after induction but prior to skin incision.
- Small, titrated doses of Hydromorphone IV boluses (0.2-0.4 mg) during the operation and before emergence, according to primary team judgment.
- Ketorolac 30 mg IV prior to skin closure, unless otherwise contraindicated.
- Avoidance of other multimodal analgesic agents not included in this protocol to limit confounders.
The infusion will be started after the skin incision and will continue until the infusion is completed or the post-anesthesia care unit (PACU) criteria are met, whichever occurs first.
Other aspects of each patient's routine clinical care will continue as per standard care at the attending physician's discretion under whom the patient is admitted, regardless of treatment arm status.
In the PACU, a brief postoperative pain questionnaire will be performed, including the Surgical Pain Scales (SPS).
The SPS is a validated scale consisting of 4 items that measure pain at rest, during normal activities, and during work/exercise and quantify the unpleasantness of worst pain. This scale has been validated in a number of different types of postoperative pain, including women after gynecologic surgery.
Vital signs, numeric rating scale (NRS) pain scores, and opioid consumption in PACU will be collected from the patient's medical record.
Patients whose surgery was converted to open, estimated blood loss (EBL) >500 ml, or any other surgical complication that necessitates hospitalization will be excluded from the trial.
For secondary outcomes, including total opioid consumption in 24, 48, and 72 hours and pain scores at postoperative day (POD)1, 2, and 3, an online survey will be done at POD1, 2, and 3, and follow-up will continue until 3 months post-op.
- Conditions
- Postoperative Pain
- Being tested
- Oxytocin, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
Intravenous Oxytocin infusion
PlaceboDrug
Also called Normal Saline, 0.9% Saline
0.9% Saline
| Study group | Role | What they receive |
|---|---|---|
| Medication | Active comparator | one group will receive Oxytocin infusion: 30 IU in 500 ml of 0.9% normal saline . Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | one group will receive 500 ml of 0.9% normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between 2-4 hours after surgery completion (in the PACU)
Secondary outcomes (14)
Perioperative opioid consumption
Compare the impact of a perioperative infusion of oxytocin on perioperative opioid consumption, by comparing the average in perioperative opioids (OMEs)
Measured: From start of infusion until approximately 6 hour mark (infusion completion)
POD1 Opioid consumption
Compare the impact of a perioperative infusion of oxytocin on perioperative opioid consumption, by comparing the average in perioperative opioids (OMEs)
Measured: In the first 24 hours after surgery
POD2 Opioid consumption
Compare the impact of a perioperative infusion of oxytocin on perioperative opioid consumption, by comparing the average in perioperative opioids (OMEs)
Measured: From 24-48 hours after surgery
POD3 Opioid consumption
Compare the impact of a perioperative infusion of oxytocin on perioperative opioid consumption, by comparing the average in perioperative opioids (OMEs)
Measured: From 48-72 hours after surgery
PACU satisfaction scores
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
Measured: Between 2-4 hours after surgery completion (in the PACU)
POD1 satisfaction scores
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
Measured: On Post-operative day 1
POD2 satisfaction scores
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
Measured: On Post-operative day 2
POD3 satisfaction scores
Compare patient postoperative satisfaction scores on an 11 -point Numerical Rating Scale between groups
Measured: On Post-operative day 3
PACU Post-operative pain
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
Measured: Between 2-4 hours after surgery completion (in the PACU)
POD1 Post-operative pain
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
Measured: On Post-operative day 1
POD2 Post-operative pain
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
Measured: On Post-operative day 2
POD3 Post-operative pain
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
Measured: On Post-operative day 3
Intraoperative hypotension (# of episodes of MAP <60 mmHg)
Assess the impact of a perioperative infusion of oxytocin on hypotension
Measured: Through surgery completion, an average of 2 hours (From start of infusion to completion end of time in the operating room)
PACU hypotension (# of episodes of MAP <60 mmHg)
Assess the impact of a perioperative infusion of oxytocin on hypotension
Measured: Between 0-4 hours after surgery completion (in the PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John J. Kowalczyk, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483659
- Sponsor's protocol ID
- 2024P001376
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30915988Brummett 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.
PubMed 28403427Bae 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.
PubMed 34774296Lundeberg 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.
PubMed 8041495Biurrun 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.
PubMed 33884702Matsuura 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.
PubMed 27980316Gimpl 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.
PubMed 11274341Baribeau 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.
PubMed 26441508Miranda-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.
PubMed 16527400Yang 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.
PubMed 8009342Madrazo 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.
PubMed 2897190Ende 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.
PubMed 29916862ACOG 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.
PubMed 19623003Kovacheva 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.
PubMed 25909969Heesen 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.
PubMed 31347151
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
- ClinicalTrials.gov ID
- NCT06483659
- Acronym / sponsor ID
- 2024P001376
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
152 women will be randomized into one of two arms; participants in the first arm (Intervention) will receive oxytocin infusion, 30 IU in 500 ml IV infusion at a rate of 5 IU/h (83.33 ml/h), the second arm (Control) will receive 0.9% normal saline 500 ml IV infusion at the same rate of 83.3 ml/h. The primary care team (anesthesia, surgery, and nursing), the research team, and the patient will all be blinded to the research arm.
The investigational research pharmacy will perform randomization; participants will be randomized in a 1:1 ratio to receive either Oxytocin or Placebo (0.9% normal saline). Randomization will be blinded to investigators to prevent bias and ensure balance in treatment arms throughout the study. Participants, surgeons, clinicians, and raters will be blinded with respect to treatment assignments. The investigational pharmacy will prepare the study drug based on the randomization assignment received.
The investigators will identify patients who have been scheduled for an elective, minimally invasive hysterectomy at Brigham and Women's Hospital by reviewing the operating room booking schedule.
Patients will be pre-screened for inclusion and exclusion criteria. Subsequently, they will be recruited for participation in this study by phone/ MGB Zoom and will be consented by electronic consent.
Once the patient is recruited and consented, they will be randomized for either the intervention group (oxytocin IV infusion) or the control group (0.9% normal saline IV infusion).
An email will be sent to those who consent with a link to the secure REDCap system containing a set of baseline questionnaires to assess relevant medical and surgical history, pre-operative pain, analgesic medication use, and psychosocial variables.
Both groups (intervention and control) will be treated pre-operatively with the following Early Recovery After Surgery (ERAS) medications, as per usual institutional practice:
- acetaminophen 1,000 mg orally
- celecoxib 400 mg orally The Investigational Research Pharmacy will be informed and prepare blinded infusions for perioperative administration (oxytocin or placebo).
The primary anesthesiology team will receive either the study medication or placebo in a 500 ml bag labeled as "Oxytocin Study Drug for IV infusion".
A recommended "Intra-Operative Analgesia Management" algorithm will be given to the primary anesthetic team. The recommended algorithm for intra-operative analgesia management will include the following:
- Fentanyl 100 mcg IV for induction.
- Dexamethasone 8 mg IV after induction but prior to skin incision.
- Small, titrated doses of Hydromorphone IV boluses (0.2-0.4 mg) during the operation and before emergence, according to primary team judgment.
- Ketorolac 30 mg IV prior to skin closure, unless otherwise contraindicated.
- Avoidance of other multimodal analgesic agents not included in this protocol to limit confounders.
The infusion will be started after the skin incision and will continue until the infusion is completed or the post-anesthesia care unit (PACU) criteria are met, whichever occurs first.
Other aspects of each patient's routine clinical care will continue as per standard care at the attending physician's discretion under whom the patient is admitted, regardless of treatment arm status.
In the PACU, a brief postoperative pain questionnaire will be performed, including the Surgical Pain Scales (SPS).
The SPS is a validated scale consisting of 4 items that measure pain at rest, during normal activities, and during work/exercise and quantify the unpleasantness of worst pain. This scale has been validated in a number of different types of postoperative pain, including women after gynecologic surgery.
Vital signs, numeric rating scale (NRS) pain scores, and opioid consumption in PACU will be collected from the patient's medical record.
Patients whose surgery was converted to open, estimated blood loss (EBL) >500 ml, or any other surgical complication that necessitates hospitalization will be excluded from the trial.
For secondary outcomes, including total opioid consumption in 24, 48, and 72 hours and pain scores at postoperative day (POD)1, 2, and 3, an online survey will be done at POD1, 2, and 3, and follow-up will continue until 3 months post-op.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medication | Active comparator | Drug: Oxytocinone group will receive Oxytocin infusion: 30 IU in 500 ml of 0.9% normal saline . |
| Placebo | Placebo comparator | Drug: Placeboone group will receive 500 ml of 0.9% normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18-65 years old
- ASA category 1-3
- Scheduled to undergo minimally invasive hysterectomy
- No documented allergy to oxytocin
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: PitocinIntravenous Oxytocin infusion | Drug | Medication |
| PlaceboAlso: Normal Saline, 0.9% Saline0.9% Saline | Drug | Placebo |
Primary outcome
Post-operative pain
Time frame: Between 2-4 hours after surgery completion (in the PACU)
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
14 secondary outcomes
Perioperative opioid consumption
Time frame: From start of infusion until approximately 6 hour mark (infusion completion)
POD1 Opioid consumption
Time frame: In the first 24 hours after surgery
POD2 Opioid consumption
Time frame: From 24-48 hours after surgery
POD3 Opioid consumption
Time frame: From 48-72 hours after surgery
PACU satisfaction scores
Time frame: Between 2-4 hours after surgery completion (in the PACU)
POD1 satisfaction scores
Time frame: On Post-operative day 1
POD2 satisfaction scores
Time frame: On Post-operative day 2
POD3 satisfaction scores
Time frame: On Post-operative day 3
PACU Post-operative pain
Time frame: Between 2-4 hours after surgery completion (in the PACU)
POD1 Post-operative pain
Time frame: On Post-operative day 1
POD2 Post-operative pain
Time frame: On Post-operative day 2
POD3 Post-operative pain
Time frame: On Post-operative day 3
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)
PACU hypotension (# of episodes of MAP <60 mmHg)
Time frame: Between 0-4 hours after surgery completion (in the PACU)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 30915988Soffin 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.
- Background: PubMed 28403427Brummett 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.
- Background: PubMed 34774296Bae 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.
- Background: PubMed 8041495Lundeberg 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.
- Background: PubMed 33884702Biurrun 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.
- Background: PubMed 27980316Matsuura 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.
- Background: PubMed 11274341Gimpl 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.
- Background: PubMed 26441508Baribeau 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.
- Background: PubMed 16527400Miranda-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.
- Background: PubMed 8009342Yang 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.
- Background: PubMed 2897190Madrazo 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.
- Background: PubMed 29916862Ende 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.
- Individual participant dataSharing planned: No
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Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin in people with Postoperative Pain, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John J. Kowalczyk, MD (617-732-8220, jkowalczyk@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: Between 2-4 hours after surgery completion (in the PACU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06483659, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.