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

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Bupivacaine 0.25%; Drug: Magnesium sulphate.; Drug: nalbuphine

• Registration Number: NCT03393572
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-03
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-08
• Primary Completion: 2018-06-05
• Study Completion: 2018-06-15
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-13
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group BN	Bupivacaine 0.25%	bupivacaine 0.25% plus nalbuphine
Group BM	Magnesium sulphate.	bupivacaine 0.25% plus magnesium sulphate.
Group BM	Bupivacaine 0.25%	bupivacaine 0.25% plus magnesium sulphate.
Group BN	nalbuphine	bupivacaine 0.25% plus nalbuphine

Primary Outcome Measures

Name	Time	Method
Rescue analgesia time	First 24 hours postoperatively	Time to first analgesia requirment(considering the extubation is the zero time)

Secondary Outcome Measures

Name	Time	Method
Total analgesic consumption	First 24 hours postoperatively	Intravenous diclofenac 75 mg will be given as rescue analgesic when VAS ≥ 4.Total diclofenac consumption will be recorded.
Visual analogue scale [VAS]	First 24 hours postoperatively	Visual analogue scale \[VAS\] will be used to measure pain score at 30 min, 1, 2, 4, 6, 8, 10, 12 and 24 h after surgery. All the study patients will be instructed about the use of the VAS scale before induction of anesthesia (VAS score 0 cm = no pain, VAS score 10 cm = worst possible pain)

Trial Locations

Locations (1)

Marwa Elbeialy; 🇪🇬 Cairo, Egypt