search
Back to results

TAP Block in Laparoscopic Cholecystectomy.

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine +magnesium sulphate
Bupivacaine only
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Assuit University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupivacaine +magnesium sulphate

Bupivacaine only

Arm Description

Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4.

Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to first dose of post-operative analgesia
hours
Postoperative nausea and vomiting
A three-point rating scale (1: no postoperative nausea and vomiting, 2: nausea without vomiting, 3: nausea with vomiting).
postoperative sedation
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.
Patient satisfaction
Patient satisfaction score ranged from 0-100 points; with 0 indicating the worst level of satisfaction and 100 indicating the best level of satisfaction.

Full Information

First Posted
July 19, 2018
Last Updated
December 24, 2019
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT03612947
Brief Title
TAP Block in Laparoscopic Cholecystectomy.
Official Title
Effect of Magnesium Sulfate When Added to TAP Block With Bupivacaine in Patients Undergoing Laparoscopic Cholecystectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine +magnesium sulphate
Arm Type
Active Comparator
Arm Description
Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4.
Arm Title
Bupivacaine only
Arm Type
Placebo Comparator
Arm Description
Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).
Intervention Type
Drug
Intervention Name(s)
Bupivacaine +magnesium sulphate
Intervention Description
Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4
Intervention Type
Drug
Intervention Name(s)
Bupivacaine only
Intervention Description
Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).
Primary Outcome Measure Information:
Title
The postoperative pain
Description
Visual analogue pain score ranging from 0-10 cm where 0 cm = no pain and 10 cm = the worst imaginable pain.
Time Frame
The first 24 hours after surgery
Secondary Outcome Measure Information:
Title
Time to first dose of post-operative analgesia
Description
hours
Time Frame
First occurrence during hospitalization (up to 24 hours postoperatively)
Title
Postoperative nausea and vomiting
Description
A three-point rating scale (1: no postoperative nausea and vomiting, 2: nausea without vomiting, 3: nausea with vomiting).
Time Frame
The first 24 hours after surgery
Title
postoperative sedation
Description
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.
Time Frame
The first 24 hours after surgery
Title
Patient satisfaction
Description
Patient satisfaction score ranged from 0-100 points; with 0 indicating the worst level of satisfaction and 100 indicating the best level of satisfaction.
Time Frame
At 24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Medicine Assuit University
City
Assiut
State/Province
Asyut
ZIP/Postal Code
71516
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

TAP Block in Laparoscopic Cholecystectomy.

We'll reach out to this number within 24 hrs