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Postoperative PainPhase 4NCT07400146

Bupivacaine With Epinephrine Over Diaphragm in Laparoscopy

A Phase 4 study testing Instillation of Bupivacaine with epinephrine over the diaphragm in people with Postoperative Pain and Shoulder Pain, run by Cedars-Sinai Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Postoperative shoulder pain is often reported to be particularly bothersome after laparoscopy. The benefits of local anesthetic, such as bupivacaine, applied to subcutaneous tissue for general postoperative pain management after surgery is well established. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Postoperative Pain, Shoulder Pain
What is being tested?
Instillation of Bupivacaine with epinephrine over the diaphragm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
2 Mar 2026to Jan 2027
Phase
Phase 4
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Provide a signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • 8 years of age or older
  • Undergoing laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.

Who cannot join

  • Pregnancy
  • Urgent/non-scheduled surgery
  • Scheduled for planned or possible concomitant non-gynecologic surgery (e.g., urologic or colorectal procedure)
  • Baseline shoulder pain
  • Baseline opioid use
  • Baseline of chronic pain syndrome
Show all 9Show fewer
  • Conversion to open surgery
  • Allergy or intolerance to bupivacaine, lidocaine (or amide class of anesthetics), oxycodone, acetaminophen, or ibuprofen
  • Planned post-operative admission

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ogechukwu Ezike, MD contact

3473371181

ogechukwu.ezike@cshs.org

Kelly Wright, MD contact

kelly.wright@cshs.org

United States1 site, 1 recruiting
  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Ogechukwu Ezike, MD, 3473371181, ogechukwu.ezike@cshs.org

    Ogechukwu Ezike, MD

    Recruiting

Other trials in United States

About this study

Official title: Instillation of Bupivacaine With Epinephrine Over Diaphragm to Reduce Postoperative Shoulder Pain Following Benign Gynecologic Laparoscopic Surgery: A Randomized Control Trial

Postoperative shoulder pain is often reported to be particularly bothersome after laparoscopy. The benefits of local anesthetic, such as bupivacaine, applied to subcutaneous tissue for general postoperative pain management after surgery is well established. However, there have been no studies on sprayed bupivacaine over the diaphragm to reduce shoulder pain in laparoscopic surgery. The purpose of the study is to evaluate if sprayed infra-diaphragmatic bupivacaine compared to placebo (saline) will improve postoperative shoulder pain in patients undergoing benign laparoscopic gynecologic surgery. The entire study will be conducted at Cedar Sinai Medical Center.

Being tested
Instillation of Bupivacaine with epinephrine over the diaphragm
Keywords
Laparoscopy, Gynecologic surgery, Bupivacaine
Medical subject headings
Pain, Postoperative, Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Instillation of Bupivacaine with epinephrine over the diaphragmDrug

    Prior to desufflation of the abdomen during the laparoscopic gynecologic procedure, the surgeon will instill 30mL of 0.25% bupivacaine with epinephrine 1:200,000 (total of 75 mg) laparoscopically aiming to cover the diaphragm with liquid.

Study groups in NCT07400146
Study groupRoleWhat they receive
Bupivacaine with epinephrineExperimentalParticipants randomized to this arm will have 30 mL of 0.25% bupivacaine with epinephrine 1:200,000 (total of 75 mg) placed over the diaphragm laparoscopically at the conclusion of the laparoscopic gynecologic procedure.
Receives: Drug: Instillation of Bupivacaine with epinephrine over the diaphragm
No interventionNo interventionNo additional intervention will be performed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-operative shoulder pain scores

    Reported right shoulder pain score using visual analog score (VAS) 24 hours postoperatively Null hypothesis = pain scores will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis = pain scores will be lower among the bupivacaine with epinephrine group

    Assessed using the validated 100-mm scale with a range of 0-10 (11-point numerical rating scale), an ordinal scale Analyzed using the Kruskall Wallis test (as the data from the scale is typically not normally distributed); pairwise analyses will then be conducted using the Dunn post-hoc test if statistically significant Assuming non-normality, data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis

    Measured: 24 hours postoperatively

Secondary outcomes (9)
  1. Post-operative generalized pain scores

    Post-operative generalized pain scores (superiority):

    Null hypothesis = pain scores will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis= pain scores will be lower among the bupivacaine with epinephrine group

    First and last reported generalized pain score in post-anaesthesia care unit (PACU) using numerical rating score Assessed using the validated 11-point numerical rating scale (0-10), an ordinal scale Analyzed using the Kruskall Wallis test (as the data from the scale is typically not normally distributed); pairwise analyses will then be conducted using the Dunn post-hoc test if statistically significant Assuming non-normality, data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis

    Measured: up to 6 hours in post-anaesthesia care unit (PACU)

  2. Total analgesic requirements in post-anaesthesia care unit (PACU) in morphine equivalents

    Calculated in morphine milligram equivalents (continuous data) Analyzed using the Kruskall-Wallis test (assuming non-normal data) Data will be presented as median (range)

    Measured: up to 6 hours in post-anaesthesia care unit (PACU)

  3. Length of stay in post-anaesthesia care unit (PACU)

    Length of stay in post-anaesthesia care unit (PACU) (superiority):

    Null hypothesis = PACU length of stay will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis= PACU length of stay will be shorter in the bupivacaine with epinephrine groups

    Documented in minutes (continuous data) Analyzed using ANOVA if normally distributed, Kruskall-Wallis test if not normally distributed

    Measured: up to 6 hours in post-anaesthesia care unit (PACU)

  4. Post-operative shoulder pain scores at home

    Daily reported post-operative shoulder pain scores at home (superiority):

    Null hypothesis = pain scores will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis = pain scores will be lower among the bupivacaine with epinephrine group

    Assessed using the validated 100-mm scale with a range of 0-10 (11-point numerical rating scale), an ordinal scale Analyzed using the Kruskall Wallis test (as the data from the scale is typically not normally distributed); pairwise analyses will then be conducted using the Dunn post-hoc test if statistically significant Assuming non-normality, data will be presented as median (range) Patients without any postoperative documentation of pain scores will be withdrawn from the study and thus excluded from the analysis

    Measured: 7 days postoperatively

  5. Post-operative opioid use

    Post-operative opioid use (superiority):

    Null hypothesis = post-op opioid use will not differ among the bupivacaine with epinephrine vs no intervention group Alternative hypothesis= post-op opioid use will be lower among the bupivacaine with epinephrine group

    Number of pills used reported by patient (interval data) Analyzed using the Kruskall-Wallis test Data will be presented as median (range)

    Measured: 1 week postoperative

  6. Surgical outcome: EBL

    Surgical outcomes: EBL (mL) Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group

    Continuous variables: estimated blood loss Analyzed using ANOVA if normally distributed, Kruskall-Wallis test if not normally distributed

    Measured: up to 8 hours

  7. Surgical outcome: operative time

    Surgical outcomes: operative time (minutes) Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group

    Continuous variables: operative time, estimated blood loss Analyzed using ANOVA if normally distributed, Kruskall-Wallis test if not normally distributed

    Measured: up to 8 hours

  8. Surgical outcome: intraoperative complications

    Surgical outcomes: intraoperative complications Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group

    Binary data: Surgical complications (yes/no) Analyzed using chi-square test

    Measured: within 1 week of surgery

  9. Surgical outcomes: conversion to laparotomy

    Surgical outcomes: conversion to laparotomy Null hypothesis = outcome will not differ between groups Alternative hypothesis = outcome will be improved in bupivacaine with epinephrine group

    Binary data: conversion to laparotomy (yes/no) Analyzed using chi-square test

    Measured: within 6 hours of surgery start time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2026
  2. Study start2 Mar 2026
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized control trial, single blind study
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07400146
Sponsor's protocol ID
STUDY00003947
Status last verified
Sep 2026
First submitted
24 Jan 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hammer A, Rositch AF, Kahlert J, Gravitt PE, Blaakaer J, Sogaard M. Global epidemiology of hysterectomy: possible impact on gynecological cancer rates. Am J Obstet Gynecol. 2015 Jul;213(1):23-29. doi: 10.1016/j.ajog.2015.02.019. Epub 2015 Feb 25.

    PubMed 25724402
  • Alperin M, Kivnick S, Poon KY. Outpatient laparoscopic hysterectomy for large uteri. J Minim Invasive Gynecol. 2012 Nov-Dec;19(6):689-94. doi: 10.1016/j.jmig.2012.06.007.

    PubMed 23084671
  • Driessen SR, Baden NL, van Zwet EW, Twijnstra AR, Jansen FW. Trends in the implementation of advanced minimally invasive gynecologic surgical procedures in the Netherlands. J Minim Invasive Gynecol. 2015 May-Jun;22(4):642-7. doi: 10.1016/j.jmig.2015.01.026. Epub 2015 Feb 3.

    PubMed 25655043
  • Johnson N, Barlow D, Lethaby A, Tavender E, Curr E, Garry R. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD003677. doi: 10.1002/14651858.CD003677.pub3.

    PubMed 16625589
  • Jaschinski T, Mosch C, Eikermann M, Neugebauer EA. Laparoscopic versus open appendectomy in patients with suspected appendicitis: a systematic review of meta-analyses of randomised controlled trials. BMC Gastroenterol. 2015 Apr 15;15:48. doi: 10.1186/s12876-015-0277-3.

    PubMed 25884671
  • Lirk P, Thiry J, Bonnet MP, Joshi GP, Bonnet F; PROSPECT Working Group. Pain management after laparoscopic hysterectomy: systematic review of literature and PROSPECT recommendations. Reg Anesth Pain Med. 2019 Apr;44(4):425-436. doi: 10.1136/rapm-2018-100024. Epub 2019 Feb 3.

    PubMed 30914471
  • Vadivelu N, Mitra S, Narayan D. Recent advances in postoperative pain management. Yale J Biol Med. 2010 Mar;83(1):11-25.

    PubMed 20351978
  • American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.

    PubMed 22227789
  • Bougie O, Blom J, Zhou G, Murji A, Thurston J. Use and misuse of opioid after gynecologic surgery. Best Pract Res Clin Obstet Gynaecol. 2022 Dec;85(Pt B):23-34. doi: 10.1016/j.bpobgyn.2022.07.005. Epub 2022 Jul 18.

    PubMed 35973919
  • Blanton E, Lamvu G, Patanwala I, Barron KI, Witzeman K, Tu FF, As-Sanie S. Non-opioid pain management in benign minimally invasive hysterectomy: A systematic review. Am J Obstet Gynecol. 2017 Jun;216(6):557-567. doi: 10.1016/j.ajog.2016.12.175. Epub 2016 Dec 30.

    PubMed 28043841
  • Clark NV, Moore K, Maghsoudlou P, North A, Ajao MO, Einarsson JI, Louie M, Schiff L, Moawad G, Cohen SL, Carey ET. Superior Hypogastric Plexus Block to Reduce Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial. Obstet Gynecol. 2021 Apr 1;137(4):648-656. doi: 10.1097/AOG.0000000000004329.

    PubMed 33706344
  • Miao L, Chen Q, Wang Y, Wang D, Zhou M. Effect of intraperitoneal infusion of ropivacaine combined with dexmedetomidine in patients undergoing total laparoscopic hysterectomy: a single-center randomized double-blinded controlled trial. Arch Gynecol Obstet. 2024 Apr;309(4):1387-1393. doi: 10.1007/s00404-023-07020-w. Epub 2023 Apr 1.

    PubMed 37004537
  • Patel R, Carvalho JC, Downey K, Kanczuk M, Bernstein P, Siddiqui N. Intraperitoneal Instillation of Lidocaine Improves Postoperative Analgesia at Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial. Anesth Analg. 2017 Feb;124(2):554-559. doi: 10.1213/ANE.0000000000001799.

    PubMed 27984226
  • Cho M, Kim CJ, Hahm TS, Lee YY, Kim TJ, Lee JW, Kim BG, Bae DS, Choi CH. Combination of a pulmonary recruitment maneuver and intraperitoneal bupivacaine for the reduction of postoperative shoulder pain in gynecologic laparoscopy: a randomized, controlled trial. Obstet Gynecol Sci. 2020 Mar;63(2):187-194. doi: 10.5468/ogs.2020.63.2.187. Epub 2020 Feb 20.

    PubMed 32206659
  • Sutchritpongsa P, Chaipakdi P, Sirimai K, Chalermchokcharoenkit A, Tanmahasamut P. Intraperitoneal sub-diaphragmatic instillation of bupivacaine plus morphine for reducing postoperative shoulder pain after gynecologic endoscopy. J Med Assoc Thai. 2013 May;96(5):513-8.

    PubMed 23745303

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Instillation of Bupivacaine with epinephrine over the diaphragm in people with Postoperative Pain and Shoulder Pain, run by Cedars-Sinai Medical Center 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 30 Sep 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Ogechukwu Ezike, MD (3473371181, ogechukwu.ezike@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative shoulder pain scores (time frame: 24 hours postoperatively). 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 NCT07400146, which also lists 18 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 30 Sep 2026.

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