Postoperative Analgesia in Laparoscopic Gynecological Surgeries

NCT06491485 | Not Yet Recruiting Phase 4

• 1 other identifier: Post laparoscopy analgesia
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Keywords

Laparoscopic gynecological surgeries

Outcome Measures

Primary Outcomes (1)

• first rescue analgesia

  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

  24 hour postoperative

Study Arms (3)

Group M (Magnesium sulfate)

EXPERIMENTAL

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.

Drug: Group M (lidocaine with Magnesium sulfate)

Group B (Sodium bicarbonate)

EXPERIMENTAL

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.

Drug: Group B (lidocaine with Sodium bicarbonate)

Group C

ACTIVE COMPARATOR

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.

Drug: Group C (lidocaine with saline)

Interventions

Group M (lidocaine with Magnesium sulfate) 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 M (Magnesium sulfate)

Group B (lidocaine with Sodium bicarbonate) 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 B (Sodium bicarbonate)

Group C (lidocaine with saline) 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.

Group C

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Gynecological surgeries
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Magnesium Sulfate; Sodium Bicarbonate; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Sodium Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds

Study Officials

• Essam Ezzat Abdel Hakeem, M.D.

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

01020643396; mh401022@gmail.com

Noha Hassan Abdelghany, M.D.

CONTACT

01069009221; noha@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07