Intraperitoneal Bupivacaine With Magnesium or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Bupivacaine 0.25%; Drug: Magnesium sulphate.; Drug: nalbuphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03393572

FMASU R49/2017

Details and patient eligibility

About

The purpose of this study is to compare between the addition of Mg sulphate or Nalbuphine to intraperitoneal bupivacaine installation in laparoscopic hysterectomy for postoperative pain control and their relative adverse effects.

Enrollment: 80 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) physical status I and II
• scheduled for laparoscopic hysterectomy

Exclusion criteria

• ASA physical status more than II
• Obesity (body mass index higher than 30 kg/ m2)
• History of chronic opioids intake
• Known hypomagnesaemia or hypermagnesaemia
• Chronic alcoholism
• Heart block
• Renal failure
• Patients with history of left ventricular failure
• Patients taking beta-blocking drugs
• Allergy to the study drugs
• if surgery changed to open hysterectomy,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Group BM

Active Comparator group

Description:

bupivacaine 0.25% plus magnesium sulphate.

Treatment:

Drug: Bupivacaine 0.25%

Drug: Magnesium sulphate.

Group BN

Active Comparator group

Description:

bupivacaine 0.25% plus nalbuphine

Treatment:

Drug: nalbuphine

Drug: Bupivacaine 0.25%