Postoperative Analgesia in Laparoscopic Gynecological Surgeries

NCT ID: NCT06491485

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-12-01

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group M (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 Type: EXPERIMENTAL

Group M (lidocaine with Magnesium sulfate)

Intervention Type: DRUG

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)

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 Type: EXPERIMENTAL

Group B (lidocaine with Sodium bicarbonate)

Intervention Type: DRUG

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 C

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.

Group Type: ACTIVE_COMPARATOR

Group C (lidocaine with saline)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Group 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Hamza Abdelrady Abdelmalek

Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Essam Ezzat Abdel Hakeem, M.D.

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Mahmoud Hamza Abd elrady, M.B.B.Ch

Role: CONTACT

mh401022@gmail.com

01020643396

Noha Hassan Abdelghany, M.D.

Role: CONTACT

noha@aun.edu.eg

01069009221

Other Identifiers

Post laparoscopy analgesia

Identifier Type: -

Identifier Source: org_study_id