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

Postoperative Pain Clinical Trial

Official title:

Efficacy and Safety of Magnesium Sulfate Added to Local Anesthetic in TAP Block for Postoperative Analgesia Following Total Abdominal Hysterectomy.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02930707
• Other study ID #: 177
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: October 10, 2016
• Last updated: October 11, 2016
• Start date: January 2016
• Est. completion date: November 2016

Study information

• Verified date: October 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Magnesium Sulfate
ultrasound guided TAP block with 20 mL of 0.25% bupivacaine plus 2 mL magnesium sulfate 10% (200 mg), on each side of the abdominal wall.
• Bupivacaine
ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total postoperative morphine consumption	total amount of rescue morphine consumption in the first 24 hours postoperatively	postoperative 24 hours	No
Secondary	postoperative pain	postoperative pain measured by VAS score recorded in the first 24 hours postoperatively	postoperative 24 hours	No
Secondary	first request of rescue analgesia	time to the first requirement of rescue analgesia during the first 24 hours postoperatively	postoperative 24 hours	No
Secondary	side effects	occurrence of side effects during the first 24 hours postoperatively	postoperative 24 hours	Yes