Randomized Controlled Trail for Post Laparoscopic Pain

Shoulder Pain Clinical Trial

Official title:

Prevention of Post-laparoscopic Shoulder and Upper Abdominal Pain: A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02745574
• Other study ID #: 2013-04-038B
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2014
• Last updated: April 16, 2016
• Start date: April 2013
• Est. completion date: March 2017

Study information

• Verified date: April 2016
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Yi Jen Chen, M.D., Ph.D.
• Email: chenyj[@]vghtpe.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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, we should try to do is that if we could reduce carbon dioxide retention in the pelvic cavity.

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

Description:

All the patients will receive laparoscopic surgery using carbon dioxide (CO2 ) gas as distension medium. At the end of the surgery, in the control group C, CO2 was removed by passive exsufflation through the port site. In the intervention group A, at the end of the surgery, 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. Then, patients will be placed in the Trendelenburg position (30 degrees), and a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm H2O. The anesthesiologists held the fifth positive pressure inflation for approximately 5 seconds. During these maneuvers, the surgeon was instructed to ensure that the trocar sleeve valve was fully open to allow the CO2 gas to escape.

In the intervention group B, at the end of the surgery, 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.

Patients will be asked to fill out questionnaires up to 48 hours to determine the frequency and severity of their shoulder and upper abdominal pain. The scores will be assessed 12, 24, 48 hours after surgery using a visual analogue scale( VAS) from 0 ( no pain) to 10 ( worst possible pain).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Procedure:
• Combined maneuver
Combined maneuver (Intraperitoneal normal saline infusion and Pulmonary recruitment maneuver): 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 0.9% normal saline fluid in the abdominal cavity. Then, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm H2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.
• Intraperitoneal infusion
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 0.9% normal saline fluid in the abdominal cavity.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Esmat ME, Elsebae MM, Nasr MM, Elsebaie SB. Combined low pressure pneumoperitoneum and intraperitoneal infusion of normal saline for reducing shoulder tip pain following laparoscopic cholecystectomy. World J Surg. 2006 Nov;30(11):1969-73. — View Citation

Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline pain score of should and upper abdominal pain at 12 hours after surgery	The main objective of this trial is to assess the efficacy of clinical maneuver to reduce shoulder and upper abdominal pain. Thus the primary outcome measure of this trial is the severity and frequency of their should and upper abdominal pain.; The pain score is based on the visual analogue scale in which patients record the intensity of their pain 12 hours after surgery. VAS consists of a subjective evaluation of the pain on a scale of 10 in which 0 is no pain and 10 the most severe pain.	Baseline and 12 hours after surgery	No
Primary	Change from baseline pain score of should and upper abdominal pain at 24 hours after surgery	The main objective of this trial is to assess the efficacy of clinical maneuver to reduce shoulder and upper abdominal pain. Thus the primary outcome measure of this trial is the severity and frequency of their should and upper abdominal pain.; The pain score is based on the visual analogue scale in which patients record the intensity of their pain 24 hours after surgery. VAS consists of a subjective evaluation of the pain on a scale of 10 in which 0 is no pain and 10 the most severe pain.	Baseline and 24 hours after surgery	No
Primary	Change from baseline pain score of should and upper abdominal pain at 48 hours after surgery	The main objective of this trial is to assess the efficacy of clinical maneuver to reduce shoulder and upper abdominal pain. Thus the primary outcome measure of this trial is the severity and frequency of their should and upper abdominal pain.; The pain score is based on the visual analogue scale in which patients record the intensity of their pain 48 hours after surgery. VAS consists of a subjective evaluation of the pain on a scale of 10 in which 0 is no pain and 10 the most severe pain.	Baseline and 48 hours after surgery	No
Secondary	Change from baseline of Nause, vomiting and abdominal distention rate at 48 hours after surgery	Secondary outcome measures included the occurrence of nausea or vomiting and abdominal distention.	Baseline and 48 hours after surgery	No