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NCT03210376 · ClinicalTrials.gov registry record · Phase 4

Neuromuscular Blockade on Shoulder Pain of Elderly

A Phase 4 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 4
Development phase
100
Enrollment target

NCT03210376: Completed Phase 4 study, sponsored by M.D. Anderson Cancer Center.

NCT03210376 is a Phase 4 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03210376, a Phase 4 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 4
Development phase
100 participants
Enrollment target

Study Summary

Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a common complaint from patients who have had abdominal surgery and the pain is thought to be related to the use of IP. In addition to anesthesia (which keeps you asleep during surgery), the current standard practice is to block the nerve-muscle junction with a type of drug called neuromuscular blockade (NMB) which paralyzes the abdominal muscles. This means that a lower level of insufflation pressure is needed by the surgeon. To reverse the effects of NMB after surgery, a drug called neostigmine is given. The goal of this clinical research study is to compare the use of standard-of-care moderate NMB and neostigmine to the use of deep NMB and a drug called Sugammadex when given to elderly patients (patients who are 65 years of age or older) who are scheduled to have robotic abdominal surgery. "Deep" and "moderate" in this study refers to the dose or strength of the NMB given. This is an investigational study. Sugammadex and neostigmine are FDA approved and commercially available for the reversal of NMB. It is considered investigational to compare Sugammadex and neostigmine to learn if the use of one or the other in elderly patients can reduce the level of shoulder pain after surgery. Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Primary Outcome

Visual Analog Scale (VAS) pain score (0-10) for shoulder pain recorded, where 0 means no pain and 10 means the worst pain ever experienced . Percentage of participants who experienced should pain.

Interventions

  • DRUG Sugammadex
  • DRUG Neostigmine
  • BEHAVIORAL Pain Assessment
  • DRUG Deep Neuromuscular Blockade (NMB)
  • DRUG Moderate Neuromuscular Blockade (NMB)

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2017-11-17
Est. Completion 2020-10-22
Phase Phase 4
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT03210376 record still lists

NCT03210376 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 5 interventions - of which Sugammadex is the first listed.

NCT03210376 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03210376 about?

NCT03210376 is a clinical study titled "Neuromuscular Blockade on Shoulder Pain of Elderly". Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a common complaint from patients who have had abdominal surgery and the pain is thought to be related to the use of IP. I...

What is the current status of trial NCT03210376?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2017-11-17. Estimated completion is 2020-10-22.

What interventions are being tested in trial NCT03210376?

The interventions under investigation include: Sugammadex (DRUG), Neostigmine (DRUG), Pain Assessment (BEHAVIORAL), Deep Neuromuscular Blockade (NMB) (DRUG), Moderate Neuromuscular Blockade (NMB) (DRUG).

Who is sponsoring clinical trial NCT03210376?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03210376's enrollment target sits among peer trials

100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03210376, the US trial registry maintained by the National Library of Medicine. NCT03210376 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.