MedTrace Logo

Different Maneuvers for Reducing Post-laparoscopic Pain

NCT04475809 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-07-20

No results posted yet for this study

Summary

* Laparoscopic surgeries are becoming more attractive because of early recovery. However, post-laparoscopic shoulder and upper abdominal pain may cause more discomfort to the patient than the pain at the incision site
* Many strategies have been attempted, such as the use of nonsteroidal anti-inflammatory drugs; however, the effect is limited, and there are no reliable methods available yet.
* Recently, some techniques are introduced that can potentially alleviate various types of pain through different mechanisms in patients after laparoscopic surgery such as low-pressure pneumoperitoneum, intraperitoneal normal saline infusion, and pulmonary recruitment maneuvers.
* the investigators conduct this randomized controlled trial to evaluate the effectiveness of different strategies on reducing the intensity of post-laparoscopic shoulder and abdominal pain in patients undergoing laparoscopic gynecologic surgeries.

Conditions

  • Gynecologic Disease

Interventions

PROCEDURE

group C

laparoscopy will be performed with 14-16 mmHg intra-abdominal pressure. At the end of the procedure routine method for CO2 removal, passive exsufflation, will be used by applying gentle abdominal pressure to evacuate the residual gas through the port site.

PROCEDURE

Group L

laparoscopy will be performed with 8-10 mmHg intra-abdominal pressure and routine passive exsufflation will be applied for CO2 removal at the end of the procedure.

PROCEDURE

Group LR

the intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure pulmonary recruitment maneuver (PRM) will be done; which consists of five manual pulmonary inflations at a maximum pressure of 40 cm H2O and the fifth will be held for 5 seconds. During this procedure, the surgeon is instructed to keep the port sleeve valve fully opened to allow the CO2 to escape the abdominal cavity.

PROCEDURE

Group LS

the intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure, intraperitoneal normal saline (IPS) will be infused for removal of the intra-abdominal CO2; in which we fill the upper part of the abdominal cavity evenly and bilaterally with isotonic normal saline (15-20 mL/kg body weight)

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2022-02-01
Completion
2022-03-01

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04475809 on ClinicalTrials.gov