Trial no.:
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PACTR201707002314115 |
Date of Approval:
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23/05/2017 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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pain relief after laparoscopic ovarian cystectomy |
Official scientific title |
Efficacy of intraperitoneal different combinations of bupivacaine, hydrocortisone or magnesium sulfate for postoperative pain relief in patients undergoing day case laparoscopic ovarian cystectomy. |
Brief summary describing the background
and objectives of the trial
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Multimodal analgesia is necessary for management of pain after laparoscopic surgeries. Patients undergoing laparoscopic procedures experience postoperative pain especially in the abdomen, back, and shoulder region which require proper attention. Pain intensity usually peaks during the first postoperative hours.
There are three components of pain after laparoscopic surgeries:
1.Visceral pain results from the stretching of the intraabdominal cavity and peritoneal inflammation.
2.Shoulder pain results from phrenic nerve irritation caused by residual carbon dioxide in the peritoneal cavity.
3.Parietal pain due to surgical incision which is much less in intensity by virtue of its small size.
This study will assess the efficacy of intraperitoneal bupivacaine, hydrocortisone and magnesium sulfate in different combinations for postoperative pain relief in patients undergoing day case laparoscopic unilateral ovarian cystectomy.
At the end of surgery with adequate hemostasis and after suctioning the peritoneal cavity of lavage solutions and blood, the study drugs combination will be instilled by the surgeon guided by the surgical camera. The 50 ml combination will be divided into 2 equal volumes (25 ml each). One of these volumes will be instilled subdiaphragmatically above the right hepatic lobe in reverse trendlenburg position. The other volume will be instilled over and around the surgical site (ovarian tissue) after returning the patient into the flat supine position. The surgeon will be asked to ensure complete deflation of the peritoneal cavity as much as possible
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Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
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Disease(s) or condition(s) being studied |
pain relief after laparoscopic ovarian cystectomy,Surgery |
Sub-Disease(s) or condition(s) being studied |
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Purpose of the trial |
Prevention |
Anticipated trial start date |
01/08/2017 |
Actual trial start date |
15/08/2017 |
Anticipated date of last follow up |
15/05/2018 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
120 |
Actual target sample size (number of participants) |
120 |
Recruitment status |
Completed |
Publication URL |
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