Clinical trial NCT06491485: Postoperative Analgesia in Laparoscopic Gynecological Surgeries
Official title: Magnesium Sulfate Versus Sodium Bicarbonate as Adjuvants to Lidocaine 1% by Intraperitoneal Instillation for Postoperative Analgesics in Laparoscopic Gynecological Surgeries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Laparoscopic gynecological surgeries
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare intraperitoneal instillation of magnesium sulfate versus sodium bicarbonate as an adjuvant to lidocaine 1% , on reducing postoperative pain in laparoscopic gynecological surgeries.

Detailed description: Patients undergoing laparoscopic surgery experience postoperative pain especially in the abdomen, lower back, and shoulders, Relieving postoperative pain, especially with certain types of analgesic agents, may reduce postoperative morbidity and mortality. It is also important to prevent adverse events such as myocardial infarction, cardiac arrhythmia, ileus, and poor wound healing and pulmonary complications. There is evidence that the main source of pain after laparoscopic surgeries is the peritoneum . Due to CO2 insufflation constitutes the commonest means of creating the pneumoperitoneum. Co2pneumoperitoneum is known to cause systemic acidosis. Which is responsible for damaging of the mesothelial lining of the peritoneum and consequent peritoneal irritation . Moreover, the phrenic nerve could be damaged by the acidic environment The use of local anesthetics has been advocated as a method for reducing postoperative pain local anesthetic intraperitoneal administration has shown good effects on reducing postoperative pain in laparoscopic cholecystectomy and gynecological surgeries . intraperitoneal sodium bicarbonate instillation may neutralize effect of the acid milieu on peritoneal cavity and the phrenic nerve damage which consecutively will lead to a reduction of postoperative pain. Magnesium sulfate, a non-competitive NMDA antagonist, has been proven in animal and human being models to have antinociceptive properties. The antinociceptive effect of magnesium sulfate relieves chronic pain and it can also decrease the duration and intensity of postoperative pain.

Eligibility criteria: Inclusion Criteria:

* age 18:60years
* patients undergoing laparoscopic gynecological surgeries,
* ASA 1\&2

Exclusion Criteria:

* patient dissatisfaction for participating in the study
* opioid use within 24 hr before the study
* allergy to the drugs used in the study and alcohol use
* chronic pain syndrome.
* neurological disease.
* steroid treatment

  * conversion of laparoscopic surgery to open surgery
  * use a drain

Primary outcomes:
measure: first rescue analgesia
timeFrame: 24 hour postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Essam Ezzat Abdel Hakeem, M.D.
role: STUDY_DIRECTOR
References: