Postoperative Analgesia in Laparoscopic Gynecological Surgeries

Assiut University

Status and phase: Not yet enrolling; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Group B (lidocaine with Sodium bicarbonate); Drug: Group C (lidocaine with saline); Drug: Group M (lidocaine with Magnesium sulfate)

Study type: Interventional

Funder types: Other

Identifiers

NCT06491485

Post laparoscopy analgesia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

Group M (Magnesium sulfate)

Experimental group

Description:

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.

Treatment:

Drug: Group M (lidocaine with Magnesium sulfate)

Group B (Sodium bicarbonate)

Experimental group

Description:

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.

Treatment:

Drug: Group B (lidocaine with Sodium bicarbonate)

Group C

Active Comparator group

Description:

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.

Treatment:

Drug: Group C (lidocaine with saline)