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NCT Number: NCT07109193

The Relationship Between Intraperitoneal Drain Placement and Postoperative Pain in Gynecologic Laparoscopy

To assess the effect of intraperitoneal drain placement on postoperative pain after Gynecologic laparoscopy To evaluate whether the use of drains contributes to improved other clinical outcomes

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Key information

Conditions

Sex eligibility

Female

Study type

Observational

About this study

Operative laparoscopy is becoming the primary approach for treatment of benign gynaecologic diseases, as it is a less invasive procedure and can help shorten the length of hospitalization., Most complications occur during abdominal access or port placement, while other complications arise during abdominal insufflations, tissue dissection, and homeostasis. However, postoperative pain at the shoulder and upper abdomen has been shown to be the most common complaint in many studies. It has been hypothesized that this is due to CO2 residue, which causes stretching of the post distended diaphragm and peritoneum after prolonged surgery. The suprapubic pain comes directly from the surgical wound, which is also affected by postoperative abdominal distension Several methods have been recommended to improve postoperative pain for ambulatory procedures, including a pulmonary recruitment maneuver,intraperitoneal infusions with saline or analgesic drugs,low pressure laparoscopic surgery,and the prescription of different types of preoperative medicine.Studies have shown peritoneal gas drain to be a procedure that could potentially be used to alleviate postoperative pain. Many previous studies have reported good results from using this procedure. Recently, a systematic review mentioned that there was little evidence to support the effectiveness of intraperitoneal gas drain in reducing postoperative pain.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective procedure: Patients scheduled for elective pure laparoscopic gynecologic surgery (e.g., ovarian cystectomy, endometriosis resection, diagnostic laparoscopy).
  • ASA Physical Status: I-II (i.e., healthy or mild systemic disease).

BMI: 18-35 kg/m².

Informed Consent: Able and willing to give written consent and comply with postoperative pain assessments.

Exclusion criteria

1 - Malignancy: Known or suspected gynecologic malignancy requiring staging or radical surgery.

  • Conversion: Intraoperative conversion to laparotomy.
  • Coagulopathy: Bleeding disorders or therapeutic anticoagulation that cannot be paused perioperatively.
  • Prior Major Pelvic Surgery: ≥ 2 previous open abdominal operations (to avoid confounding from adhesions).
  • Intra-Abdominal Infection: Active pelvic inflammatory disease or untreated urinary tract infection.
  • Chronic Pain/Opioid Use: Regular opioid use or chronic pelvic pain syndromes (endometriosis pain > 6 months).
  • Allergy/Contraindication: Allergy to standard analgesics or contraindication to intraperitoneal drain placement (e.g., severe adhesions).

Treatment and study plan

Primary outcomes

  1. Corelation between intraperitoneal drain placement and Postoperative pain in Gynecologic laparoscopy

    Time frame: Baseline

    Evalute post operative pain levels and discomfort through Visual Analouge Scale (VAS) score

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Qayed

CONTACT

[email protected]

0201142914797

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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