Clinical trial NCT03845608: Analgesic Effect of Pulmonary Recruitment and Intraperitoneal Hydrocortisone in Laparoscopic Gynecological Surgery
Official title: Postoperative Analgesic Efficacy of the Pulmonary Recruitment Maneuver Compared to Intraperitoneal Hydrocortisone in Laparoscopic Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Laparoscopic Gynecological Surgery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 45
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The first 24 hours total analgesic consumption.
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Length of the recovery and hospital stay (hours)
timeFrame: 24 hours postoperative
measure: Incidence of postoperative nausea ,vomiting or abdominal distension(%)
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Nesrine El-Refai, MD
role: PRINCIPAL_INVESTIGATOR
References:
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