Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02811081
Other study ID # 2016-05-048
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 26, 2016
Est. completion date July 30, 2017

Study information

Verified date May 2018
Source Kangbuk Samsung Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this clinical trial is to estimate the efficacy and safety of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.


Description:

Shoulder pain after laparoscopy is common and its probable mechanism is residual carbon dioxide gas after surgery. Both the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver could effectively reduce post-laparoscopic shoulder pain. However, the efficacy and safety of combined intervention with normal saline instillation and pulmonary recruitment maneuver have not been investigated yet. The aim of this clinical trial is to estimate the effectiveness of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date July 30, 2017
Est. primary completion date April 19, 2017
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria:

- patients undergoing laparoscopy for benign gynecologic diseases

- patients aged 19-65 years

- patients with american society of anesthesiology physical status I-II

- patients obtaining written informed consent

Exclusion Criteria:

- patients with chronic shoulder pain, chronic epigastric pain or chronic pain syndrome

- patients with past history of pneumothorax or any pulmonary surgical history

- patients with any shoulder surgery histories

- patients who required to conversion to open surgery from laparoscopic surgery

- patients who required to receive incidental upper abdominal surgeries due to adhesion and injury at upper abdominal cavity

- patients with inability to understand or express 10 point visual analogue scale

- pregnant women

Study Design


Intervention

Procedure:
Passive Deflation
In the control group, residual carbon dioxide gas was evacuated by the routine method using passive exsufflation through the port site at the end of surgery.
Normal Saline Instillation
In the normal saline instillation group, in addition to the routine method, the patients were placed in the Trendelenburg position (30°), isotonic normal saline (20 ml/kg of body weight) was infused in the sub-diaphragmatic region at the end of surgery.
Normal Saline Instillation + Pulmonary Recruitment
In the combined intervention group, in addition to the routine method, the patients were placed in the Trendelenburg position (30°), and a pulmonary recruitment maneuver was performed after instillation of isotonic normal saline (20 ml/kg of body weight) in the sub-diaphragmatic region at the end of surgery.

Locations

Country Name City State
Korea, Republic of Kangbuk Samsung Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Shoulder pain evaluated by 10 point visual analogue scale The pain score was evaluated by 10 point visual analogue scale. after two day of procedure
Secondary Wound pain evaluated by 10 point visual analogue scale The pain score was evaluated by 10 point visual analogue scale. after two day of procedure
See also
  Status Clinical Trial Phase
Completed NCT02567838 - Lidocaine Gel During Transrectal Sonography Phase 3
Completed NCT02596425 - Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain Phase 3
Completed NCT02654808 - AirSeal®Insufflation Trocar/CO2 Absorption Study N/A
Withdrawn NCT00734812 - Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy Phase 3
Completed NCT00456924 - Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914 Phase 2
Completed NCT02357251 - Enhanced Recovery After Surgery: A RCT of Perioperative Management of Gynecologic Patients N/A
Completed NCT00526331 - Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy Phase 4
Completed NCT02729272 - Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy N/A