Clinical trial NCT02745574: Randomized Controlled Trail for Post Laparoscopic Pain
Official title: Prevention of Post-laparoscopic Shoulder and Upper Abdominal Pain: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Keywords: should and upper abdominal pain, post-laparoscopy
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2016-04-20
Enrollment: 360
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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, 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline pain score of should and upper abdominal pain at 12 hours after surgery
timeFrame: Baseline and 12 hours after surgery
measure: Change from baseline pain score of should and upper abdominal pain at 24 hours after surgery
timeFrame: Baseline and 24 hours after surgery
measure: Change from baseline pain score of should and upper abdominal pain at 48 hours after surgery
timeFrame: Baseline and 48 hours after surgery
Secondary outcomes:
measure: Change from baseline of Nause, vomiting and abdominal distention rate at 48 hours after surgery
timeFrame: Baseline and 48 hours after surgery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taipei
name: Yi Jen Chen, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Taipei Veterans General Hostipal, Taipei
name: Hsiao Wen Tsai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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. doi: 10.1007/s00268-005-0752-z.