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Analgesic Effect of Pulmonary Recruitment and Intraperitoneal Hydrocortisone in Laparoscopic Gynecological Surgery

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Cairo University (CU)

Status and phase

Unknown
Phase 4

Conditions

Laparoscopic Gynecological Surgery

Treatments

Combination Product: Pulmonary Recruitment Maneuver

Study type

Interventional

Funder types

Other

Identifiers

NCT03845608
pain and laparoscopic surgery

Details and patient eligibility

About

The aim of this study is to compare the postoperative analgesic efficacy of intraperitoneal hydrocortisone to pulmonary recruitment maneuver in Laparoscopic gynaecological surgery.

Full description

Laparoscopic surgeries are becoming more attractive because of an early recovery . However, post laparoscopic shoulder and upper abdominal pain may cause more discomfort to the patient than the pain at the incision site.

Proper pain relief is a major concern and area of focus. Pre-operatively, one of the most common questions asked by patients about the amount of pain they will experience after the surgery. Pain has been found to be one of the three most common medical causes of delayed discharge after ambulatory surgery, the other two being drowsiness and nausea and vomiting. Unfortunately prevention and treatment of postoperative pain continues to be a major challenge in postoperative care.

Good pain control after surgery is important to prevent negative outcomes such as tachycardia, hypertension, myocardial ischemia, decrease in alveolar ventilation, and poor wound healing.

Pain also can prolong hospital stay, which is particularly important in day case procedures.

The mechanism of laparoscopy induced shoulder pain is mainly derived from carbon dioxide retention within the abdomen, subsequently irritating the phrenic nerve and causing referred pain in the C4 dermatome. Moreover, carbon dioxide trapped between the liver and the right diaphragm, irritating the diaphragm, also causes upper abdominal pain.

Although there are many analgesic drugs available for postoperative pain, many patients still find them to be suboptimal for controlling pain.

Many strategies, including treatment with non steroidal anti-inflammatory drugs, have been used to try to reduce laparoscopy-induced shoulder pain however, no sufficiently reliable methods have been reported yet .

Also Intraperitoneal local anesthetic was tried as an important addition for postoperative pain in the era of modern surgery. The method of delivering local anesthetic directly to the intraperitoneal cavity was first described in 1951 by Griffin et al. ; however, this method was forgotten for many years until its implementation in minimal access surgery was reappeared. It significantly reduces postoperative pain and opioid consumption after laparoscopic gynecological and general surgical operations.

Another effective method is the pulmonary recruitment maneuver (PRM) which can mechanically remove residual carbon dioxide and therefore decreasing peritoneal irritation, and shoulder pain.

Intravenous steroids have been used successfully for postoperative pain relief in different kinds of surgery . Also intraperitoneal hydrocortisone was has been used effectively to reduce pain after laparoscopic cholecystectomy.

In addition combination of intraperitoneal local anesthetics with hydrocortisone was proved to be a successful method in controlling upper abdominal and shoulder pain after laparoscopic procedures.

Enrollment

45 estimated patients

Sex

Female

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • • female gender, age 20-45 years undergoing laparoscopic gynecological operations

    • American Society of Anesthesiologist physical status classification of I or II

Exclusion criteria

  • • Patients younger than 20 years or older than 45 years

    • History of chronic pain
    • Regular medication with analgesics, or steroids
    • Analgesic use within 24 h of surgery ,drug or alcohol abuse
    • Associated chronic diseases like diabetes mellitus, pulmonary diseases ,poor cardiac reserve,hepatorenal insufficiency.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

45 participants in 3 patient groups

Pulmonary Recruitment Maneuver
Experimental group
Description:
Pulmonary recruitment maneuver will be performed manually using positive-pressure ventilation to inflate the lungs and lower the diaphragm, which can increase intraperitoneal pressure mechanically and remove residual carbon dioxide from the peritoneal cavity
Treatment:
Combination Product: Pulmonary Recruitment Maneuver
Intraperitoneal Hydrocortisone
Other group
Description:
Drug Injection: 100mg of Hydrocortisone will be injected In the peritoneum
Treatment:
Combination Product: Pulmonary Recruitment Maneuver
control group
No Intervention group
Description:
In the controls, carbon dioxide will be removed by the traditional passive deflation of abdominal cavity.

Trial contacts and locations

0

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Central trial contact

Atef Abdelmawla; Nesrine El-Refai, MD

Data sourced from clinicaltrials.gov

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