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

NCT03845608 | Unknown Phase 4

• 1 other identifier: pain and laparoscopic surgery
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Laparoscopic Gynecological Surgery

Outcome Measures

Primary Outcomes (1)

• The first 24 hours total analgesic consumption.

  Total amount of opioid drugs used after surgery for assessment of post operative pain

  24 hours after surgery

Secondary Outcomes (2)

• Length of the recovery and hospital stay (hours)

  24 hours postoperative

• Incidence of postoperative nausea ,vomiting or abdominal distension(%)

  24 hours postoperative

Study Arms (3)

Pulmonary Recruitment Maneuver

EXPERIMENTAL

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

Combination Product: Pulmonary Recruitment Maneuver

Intraperitoneal Hydrocortisone

OTHER

Drug Injection: 100mg of Hydrocortisone will be injected In the peritoneum

Combination Product: Pulmonary Recruitment Maneuver

control group

NO INTERVENTION

In the controls, carbon dioxide will be removed by the traditional passive deflation of abdominal cavity.

Interventions

Pulmonary Recruitment Maneuver COMBINATION_PRODUCT

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.recieve100 mg hydrocortisone in 250 ml normal saline at end of surgery and carbon dioxide will be removed by applying gentle abdominal pressure and removing carbon dioxide by passive exsufflation

Intraperitoneal Hydrocortisone; Pulmonary Recruitment Maneuver

Eligibility Criteria

• Age: 20 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female gender, age 20-45 years undergoing laparoscopic gynecological operations
• American Society of Anesthesiologist physical status classification of I or II

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (8)

• Kluivers KB, Johnson NP, Chien P, Vierhout ME, Bongers M, Mol BW. Comparison of laparoscopic and abdominal hysterectomy in terms of quality of life: a systematic review. Eur J Obstet Gynecol Reprod Biol. 2008 Jan;136(1):3-8. doi: 10.1016/j.ejogrb.2007.06.004. Epub 2007 Dec 11.

  PMID: 18063290 BACKGROUND

• Vadivelu N, Mitra S, Narayan D. Recent advances in postoperative pain management. Yale J Biol Med. 2010 Mar;83(1):11-25.

  PMID: 20351978 BACKGROUND

• Jackson SA, Laurence AS, Hill JC. Does post-laparoscopy pain relate to residual carbon dioxide? Anaesthesia. 1996 May;51(5):485-7. doi: 10.1111/j.1365-2044.1996.tb07798.x.

  PMID: 8694166 BACKGROUND

• Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.

  PMID: 9389858 BACKGROUND

• Kahokehr A. Intraperitoneal local anesthetic for postoperative pain. Saudi J Anaesth. 2013 Jan;7(1):5. doi: 10.4103/1658-354X.109554. No abstract available.

  PMID: 23717222 BACKGROUND

• Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.

  PMID: 22184293 BACKGROUND

• 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.

  PMID: 18448749 BACKGROUND

• Safavi M, Honarmand A, Habibabady MR, Baraty S, Aghadavoudi O. Assessing intravenous ketamine and intravenous dexamethasone separately and in combination for early oral intake, vomiting and postoperative pain relief in children following tonsillectomy. Med Arh. 2012;66(2):111-5. doi: 10.5455/medarh.2012.66.111-115.

  PMID: 22486143 BACKGROUND

Study Officials

• Nesrine El-Refai, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Atef Abdelmawla

CONTACT

01286970031; dratef@rocketmail.com

Nesrine El-Refai, MD

CONTACT

01001775623; nesrinerefai@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: February 19, 2019
• Study Start: March 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: February 19, 2019

Record last verified: 2019-02