TAP Block in Laparoscopic Cholecystectomy.

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03612947
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.4
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

Ultrasound-guided transversus abdominis plane block is now widely used in abdominal surgery. Recently, magnesium sulphate is used as adjuvant to local anesthetics.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Bupivacaine +magnesium sulphate; Drug: Bupivacaine only	Phase 2

Detailed Description

A significant pain experienced by patients after laparoscopic cholecystectomy surgery is required so as to block nociceptive transmission from both the abdominal wall incision, and visceral sites.

Using of opioids can result in significant adverse effects, thus delaying early mobilization of patients.

Ultrasound-guided transversus abdominis plane (TAP) block has been used as a satisfactory approach that provides postoperative analgesia. TAP block is safe; it diminishes or replaces the use of opioids; and it has a lower incidence of adverse effects.

Bupivacaine is a medication used to decrease feeling in a specific area. It is used by injecting it into the area, around a nerve that supplies the area, or into the spinal canal's epidural space. Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks.

Magnesium is the fourth most plentiful cation in our body. It may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising.

Magnesium sulphate (MgSO4), N-methyl-D-aspartate receptor antagonist has the potential to be an ideal adjuvant in TAP block.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effect of Magnesium Sulfate When Added to TAP Block With Bupivacaine in Patients Undergoing Laparoscopic Cholecystectomy.
• Actual Study Start Date: Sep 3, 2018
• Actual Primary Completion Date: Dec 15, 2019
• Actual Study Completion Date: Dec 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bupivacaine +magnesium sulphate Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4.	Drug: Bupivacaine +magnesium sulphate; Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4
Placebo Comparator: Bupivacaine only Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).	Drug: Bupivacaine only; Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).

Outcome Measures

Primary Outcome Measures

1. The postoperative pain [The first 24 hours after surgery]

   Visual analogue pain score ranging from 0-10 cm where 0 cm = no pain and 10 cm = the worst imaginable pain.

Secondary Outcome Measures

1. Time to first dose of post-operative analgesia [First occurrence during hospitalization (up to 24 hours postoperatively)]

   hours

2. Postoperative nausea and vomiting [The first 24 hours after surgery]

   A three-point rating scale (1: no postoperative nausea and vomiting, 2: nausea without vomiting, 3: nausea with vomiting).

3. postoperative sedation [The first 24 hours after surgery]

   Ramsay sedation score as follows: (1) anxious and irritable or dysphoric or both; (2) co-operational, oriented and quiet; (3) responsive to command; (4) asleep, quickly responsive to light tap or loud auditory stimulus; (5) asleep, slowly responsive to light tap or loud auditory stimulus; and (6) asleep, no response to light tap or loud auditory stimulus.

4. Patient satisfaction [At 24 hours after surgery]

   Patient satisfaction score ranged from 0-100 points; with 0 indicating the worst level of satisfaction and 100 indicating the best level of satisfaction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients (age: 18-65 years old) undergoing laparoscopic cholecystectomy.

Exclusion Criteria:

• Patient refusal

• Patients with a history of cardiac, or respiratory diseases ( >ASA III).

• Patients with allergy to amide local anesthetics or medication included in the study.

• Infection at the needle insertion site.

• Pregnancy

• BMI >35

• Drug abusers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Assuit University	Assiut	Asyut	Egypt	71516

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seham Mohamed Moeen Ibrahim, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03612947
• Other Study ID Numbers: 52018
• First Posted: Aug 2, 2018
• Last Update Posted: Dec 26, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Magnesium Sulfate; Bupivacaine

Study Results

No Results Posted as of Dec 26, 2019