Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02036827
Enrollment
108
Registered
2014-01-15
Start date
2013-12-31
Completion date
2015-01-31
Last updated
2015-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Pain, Postoperative, Neuromuscular Blocking Agents, Laparoscopy

Brief summary

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.

Detailed description

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.

Interventions

DRUGRocuronium

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Shoulder tip painupto postoperative 24 hoursThe severity of shoulder tip pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours.

Secondary

MeasureTime frameDescription
Postoperative nausea and vomitingupto postoperative 24hoursThe severity of nausea, the number of vomiting and the dose and number of administration of rescue antiemetics will be recorded.
Intraoperative hemodynamicsupto postoperative 24hoursHeart 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.
Postoperative painupto postoperative 24 hoursThe severity and the location of postoperative pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours after operation.
Satisfaction of the surgeonupto postoperative 24 hoursSatisfaction of the surgeon will be measured by 5-scale numeric rating scale) at the completion of surgery.
Working intrabdominal spaceupto postoperative 24 hoursWorking intrabdominal space will be measured by grasper (from skin to sacral promontory) at the completion of carbon dioxide insufflation.
pulmonary complianceupto postoperative 24 hoursTotal 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026