Reducing Shoulder Tip Pain Following Laparoscopic Surgery

Phase 3

• Conditions: Shoulder Pain; Laparoscopic Surgery
• Interventions: Procedure: Pulmonary recruitment maneuver; Procedure: Intraperitoneal normal saline; Procedure: Control group

• Registration Number: NCT01135836
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter hospitalizations, and less post-operative pain as compared with traditional laparotomies. However, there is marked interindividual variability of post-operative shoulder-tip pain following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and ranges from mild to severe. In some cases, it has been reported to last more than 72 hours after surgery.

The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic nerve irritation causes referred pain to C4. Therefore, the investigators should try to reduce carbon dioxide retention in the pelvic cavity.

Detailed Description

This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative should-tip pain following laparoscopic surgery.

Study Timeline

• Study Start: 2009-08
• Status Verified: 2010-06
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Last Update Submitted: 2010-06-02
• Study First Posted: 2010-06-03
• Last Update Posted: 2010-06-03
• Primary Completion: 2010-09
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• Patients receive benign gynaecological laparoscopic surgery.
• American Society of Anesthesiologists (ASA) physical status of patient:

classification I-II

Exclusion Criteria

• The procedure will be required to conversion to laparotomy.
• Any cardio-vascular diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pulmonary recruitment maneuver	Pulmonary recruitment maneuver	a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm H2O. The anestheiologist held the fifth positive pressure inflation for approximately 5 seconds.
intraperitoneal normal saline	Intraperitoneal normal saline	the upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500 cc. We will leave the fluid in the abdominal cavity
Control group	Control group	CO2 was removed by passive exsufflation through the port site.

Primary Outcome Measures

Name	Time	Method
the severity and frequency of shoulder-tip pain after laparoscopic surgery	the first 48 hours after the surgery	We will follow the patients in the first 48 hours after the surgery. The primary outcome measure of this trial is the severity and frequency of shoulder-tip pain after laparoscopic surgery.; The main objective of this trial is to assess the efficacy of clinical maneuver to reduce shoulder-tip pain after laparoscopic surgery.

Secondary Outcome Measures

Name	Time	Method
Nausea or abdominal fullness after laparoscopic surgery	the first 48 hours after the surgery	Postoperative illness, such as nausea, vomiting or abdominal fullness were also recorded.

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan