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

Phase 4CompletedNCT02036827

Yonsei University108 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

108

Conditions

Pain, Postoperative

Interventions

RocuroniumDRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Gangnam severance hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Shoulder tip pain

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

Time frame: upto postoperative 24 hours

Secondary Outcomes

Postoperative pain

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

Time frame: upto postoperative 24 hours

Postoperative nausea and vomiting

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

Time frame: upto postoperative 24hours

Intraoperative hemodynamics

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.

Time frame: upto postoperative 24hours

pulmonary compliance

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

Time frame: upto postoperative 24 hours

Satisfaction of the surgeon

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

Time frame: upto postoperative 24 hours

Data from ClinicalTrials.gov

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