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Completed

NCT Number: NCT02036827

The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy

The purpose of this study was to investigate whether there is any difference in incidence of shoulder tip pain after laparoscopic cholecystectomy between the groups with moderate neuromuscular block and deep neuromuscular block.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gangnam severance hospital

Seoul, South Korea

About this study

Laparoscopic cholecystectomy has become the gold standard treatment for gall bladder disease. However, 30-50% of patients suffer from shoulder tip pain, which might arise from diaphragm stretch due to pneumoperitoneum.

In the previous pilot study, working intra-abdominal space was increased in the condition of deep neuromuscular blockade. And thus investigators hypothesized that the depth of neuromuscular blockade can affect insufflation pressure and intra-abdominal volume, which result in the severity of diaphragm stretch and postoperative shoulder pain. In addition, the depth of neuromuscular blockade can alter pulmonary compliance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • physical status by American society of Anesthesiology; 1 or 2 patients
  • patients with benign gallbladder disease scheduled for laparoscopic cholecystectomy

Exclusion criteria

  • patient with myasthenia gravis
  • allergy to rocuronium or sugammadex
  • patient with shoulder pain disease (Ex. rotator cuff tear)
  • psychological disease
  • patients who cannot understand Korean

Treatment and study plan

Rocuronium

Drug

We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized.

Other names: Neurpmuscular blockade is provides vy Rocuronium Bromide

Primary outcomes

  1. Shoulder tip pain

    Time frame: upto postoperative 24 hours

    The severity of shoulder tip pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours.

Secondary outcomes

  1. Postoperative pain

    Time frame: upto postoperative 24 hours

    The severity and the location of postoperative pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours after operation.

  2. Postoperative nausea and vomiting

    Time frame: upto postoperative 24hours

    The severity of nausea, the number of vomiting and the dose and number of administration of rescue antiemetics will be recorded.

  3. Intraoperative hemodynamics

    Time frame: upto postoperative 24hours

    Heart rate and blood pressure will be measured at the completion of anesthetic induction, at the completion of carbon dioxide insufflation, at 15 minutes after carbon dioxide insufflation, at the completion of desufflation of pneumoperitoneum, and at the completion of operation.

  4. pulmonary compliance

    Time frame: upto postoperative 24 hours

    Total lung compliance will be measured by the equation : CT (L/cm H2O) = change in volume/ change in pleural pressure It will be measured at the completion of anesthetic induction, at the completion of carbon dioxide insufflation, at 15 minutes after carbon dioxide insufflation, at the completion of desufflation of pneumoperitoneum, and at the completion of operation

  5. Satisfaction of the surgeon

    Time frame: upto postoperative 24 hours

    Satisfaction of the surgeon will be measured by 5-scale numeric rating scale) at the completion of surgery.

  6. Working intrabdominal space

    Time frame: upto postoperative 24 hours

    Working intrabdominal space will be measured by grasper (from skin to sacral promontory) at the completion of carbon dioxide insufflation.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 15, 2014
Registry last updated
Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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