TAP Block With Magnesium Sulfate Added to Local Anesthetic in Abdominal Hysterectomy

Phase 2

• Conditions: Postoperative Pain
• Interventions: Drug: Magnesium Sulfate; Drug: Bupivacaine

• Registration Number: NCT02930707
• Lead Sponsor: Assiut University

Brief Summary

Major abdominal surgeries are associated with severe abdominal pain, which can affect respiratory and cardiac functions, if insufficiently managed. This increases the incidence of post-operative morbidity.

The objective of this study was to detect the efficacy and safety of magnesium sulphate as an adjuvant to the analgesia offered by local anesthetic in ultrasound guided TAP block in patients undergoing total abdominal hysterectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-06
• Status Verified: 2016-10
• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-11
• Last Update Submitted: 2016-10-11
• Study First Posted: 2016-10-12
• Last Update Posted: 2016-10-12
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• weight: 50- 85 kg.
• ASA score: I-III
• scheduled for total abdominal hysterectomy

Exclusion Criteria

• history of relevant drug allergy.
• coagulation disorders.
• opioid dependence.
• sepsis.
• psychiatric illnesses that would interfere with perception and assessment of pain.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Magnesium group	Magnesium Sulfate	patients received ultrasound guided TAP block with 20 mL of 0.25% bupivacaine plus 2 mL magnesium sulphate 10% (200 mg), on each side of the abdominal wall.
control group	Bupivacaine	patients received ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.

Primary Outcome Measures

Name	Time	Method
total postoperative morphine consumption	postoperative 24 hours	total amount of rescue morphine consumption in the first 24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
postoperative pain	postoperative 24 hours	postoperative pain measured by VAS score recorded in the first 24 hours postoperatively
first request of rescue analgesia	postoperative 24 hours	time to the first requirement of rescue analgesia during the first 24 hours postoperatively
side effects	postoperative 24 hours	occurrence of side effects during the first 24 hours postoperatively