MedPath

Postoperative Analgesia in Laparoscopic Gynecological Surgeries

Phase 4
Not yet recruiting
Conditions
Postoperative Pain
Interventions
Drug: Group M (lidocaine with Magnesium sulfate)
Drug: Group B (lidocaine with Sodium bicarbonate)
Drug: Group C (lidocaine with saline)
Registration Number
NCT06491485
Lead Sponsor
Assiut University
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
90
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group M (Magnesium sulfate)Group M (lidocaine with Magnesium sulfate)a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine with magnesium sulfate 50 mg/kg (maximum 2g) will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.
Group B (Sodium bicarbonate)Group B (lidocaine with Sodium bicarbonate)a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine with 50 ml 4.2% sodium bicarbonate will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.
Group CGroup C (lidocaine with saline)a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.
Primary Outcome Measures
NameTimeMethod
first rescue analgesia24 hour postoperative

The first request for analgesia will be recorded by the nurse, and in case of pain in VAS more than 3, 1 gm of paracetamol will be administrated as a rescue analgesic if failed fentanyl 100mic will be added

Secondary Outcome Measures
NameTimeMethod
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