Transversus Abdominis Plane Block Versus Erector Spinae Plane Block

• Sponsor: Hassan Mokhtar Elshorbagy Hetta (Other)
• Overall Status: Completed
• CT.gov ID: NCT03989570
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 3
• Actual Duration (Months): 9
• Patients Per Site Per Month: 11.1

Study Details

Study Description

Brief Summary

The TAP block, first described by Rafi in 2001, is comprised of deposition of a local anesthetic into the anatomical plane between the internal oblique and transverses abdominis muscles, where thess thoracoabdominal nerves (T6-L1) contribute to the main sensory supply of the skin, muscles, and parietal peritoneum of the anterior abdominal wall. These nerves branch and communicate extensively with each other in the TAP .

Erector spinae plane (ESP) block is a recently described interfascial block in which the local anaesthectic is placed over or below the plane of the erector spinae muscle, near where the spinal nerves come out from the spine before they start to divide. Some publications have shown its effectiveness in treating thoracic and abdominal postoperative pain.

Postoperative pain is the major obstacle for early postoperative ambulation and increases the risk of venous thromboembolism, respiratory complications and prolongs the hospital stay. Parietal pain is the chief component of postoperative pain after abdominal surgeries. Large doses of opioids are required to mitigate this pain, but they are poorly tolerated. Multimodal analgesia is effective in handling postoperative pain and in attenuating the side effects of large doses of a single analgesic .

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Laparotomy	Procedure: transversus abdominis plane block; Procedure: erector spinae plane block; Other: control group	N/A

Detailed Description

Group I (A group): Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).

Group II (B group): Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).

Group III (C group): anesthetized with the protocol followed by Minia University Hospital The medication will be prepared and supplied in similar syringes by an anesthetist not included in the management of the patint or data collection.

Methods:

Following placement of the standard monitors, intravenous access will secured and the patients will started on IV fluids. Anesthesia will be induced with 0.04 mg/kg midazolam, 2 μg/kg fentanyl, and titrated doses of propofol. Endotracheal intubation will facilitated with 0.5 mg/kg of atracurium. Isoflurane 1.2%, will be used for anesthetic maintenance After induction of anesthesia, stabilizing the patient's hemodynamics, and before surgical incision, ESB & TAP block will be performed. With the patient in the supine position, the site of the ultrasound and needle entry will be sterilized. The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected. Then the patient will turn in lateral position, the site of the ultrasound and needle entry will be sterilized. The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Ultrasound Guided Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Patients Undergoing Emergency Laparotomies.
• Actual Study Start Date: May 15, 2019
• Actual Primary Completion Date: Feb 1, 2020
• Actual Study Completion Date: Feb 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group I (A group) 31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).	Procedure: erector spinae plane block; The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes
Active Comparator: Group II (B group) 31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).	Procedure: transversus abdominis plane block; The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected
Placebo Comparator: Group III (C group) 31 patients anesthetized with the protocol followed by Minia University Hospital	Other: control group; placebo

Outcome Measures

Primary Outcome Measures

1. Time of First Post Operative Analgesic Request [24 hours]

   the pain will be assisted based on the time for the first dose of rescue analgesia

2. Postoperative Total Fentanyl Requirement [24 hours]

   The total amount of postoperative fentanyl in milligram was given to the patient as rescue analgesia during 24 hours

Secondary Outcome Measures

1. Incidence of Any Adverse Events [5 days]

   adverse events related to technique or drugs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 1. Age18-70 . 2. Both gender . 3 .Emergency laparotomies . 4. ASA I-III .

Exclusion Criteria:

1. Drug allergy .

2. Morbid obesity (BMI >40 kg/m2) .

3. Psychiatric disorder .

4. Opioid dependence .

5. patient refuse

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minia University Hospital	Minya		Egypt	61511

Sponsors and Collaborators

• Hassan Mokhtar Elshorbagy Hetta

Investigators

• Study Chair: Nagy S. Ali, MD, Minia University Hospital
• Study Director: Abeer A Hassanien, Minia University Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 8, 2020

More Information

Publications

None provided.

• Responsible Party: Hassan Mokhtar Elshorbagy Hetta, assistant lecture, Minia University
• ClinicalTrials.gov Identifier: NCT03989570
• Other Study ID Numbers: 73-7/2018
• First Posted: Jun 18, 2019
• Last Update Posted: Jun 30, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Hassan Mokhtar Elshorbagy Hetta, assistant lecture, Minia University: Erector Spinae Plane Block; Transversus Abdominis Plane Block
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

Participant Flow

Pre-assignment Detail	7 patient refuse to participate

Arm/Group Title	Group I (A Group)	Group II (B Group)	Group III (C Group)
Arm/Group Description	31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side). erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes	31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side). transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected	31 patients anesthetized with the protocol followed by Minia University Hospital control group: placebo
Period Title: Overall Study
STARTED	31	31	31
COMPLETED	31	31	31
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Group I (A Group)	Group II (B Group)	Group III (C Group)	Total
Arm/Group Description	31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side). erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes	31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side). transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected	31 patients anesthetized with the protocol followed by Minia University Hospital control group: placebo	Total of all reporting groups
Overall Participants	31	31	31	93
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.8 (14.9)	47.4 (11.8)	43.6 (13.7)	45.61 (13.46)
Sex: Female, Male (Count of Participants)
Female	15 48.4%	14 45.2%	16 51.6%	45 48.4%
Male	16 51.6%	17 54.8%	15 48.4%	48 51.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	31 100%	31 100%	31 100%	93 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	31 100%	31 100%	31 100%	93 100%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Egypt	31 100%	31 100%	31 100%	93 100%

Outcome Measures

1. Primary Outcome

Title	Time of First Post Operative Analgesic Request
Description	the pain will be assisted based on the time for the first dose of rescue analgesia
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (A Group)	Group II (B Group)	Group III (C Group)
Arm/Group Description	31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side). erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes	31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side). transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected	31 patients anesthetized with the protocol followed by Minia University Hospital control group: placebo
Measure Participants	31	31	31
Mean (Standard Deviation) [Hour]	14.9 (5.7)	6.5 (2.2)	2.8 (1.6)

2. Primary Outcome

Title	Postoperative Total Fentanyl Requirement
Description	The total amount of postoperative fentanyl in milligram was given to the patient as rescue analgesia during 24 hours
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (A Group)	Group II (B Group)	Group III (C Group)
Arm/Group Description	31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side). erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes	31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side). transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected	31 patients anesthetized with the protocol followed by Minia University Hospital control group: placebo
Measure Participants	31	31	31
Mean (Standard Deviation) [Milligram]	40.3 (26.7)	111 (38.1)	175 (38.9)

3. Secondary Outcome

Title	Incidence of Any Adverse Events
Description	adverse events related to technique or drugs
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (A Group)	Group II (B Group)	Group III (C Group)
Arm/Group Description	31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side). erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes	31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side). transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected	31 patients anesthetized with the protocol followed by Minia University Hospital control group: placebo
Measure Participants	31	31	31
Number [participants]	0 0%	0 0%	0 0%

Adverse Events

Time Frame	5 days
Adverse Event Reporting Description	All patients were under control and receive the best care of management Our techniques don't make any side effects or affect patients outcome
Arm/Group Title	Group I (A Group)		Group II (B Group)		Group III (C Group)
Arm/Group Description	31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side). erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes		31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side). transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected		31 patients anesthetized with the protocol followed by Minia University Hospital control group: placebo
All Cause Mortality
	Group I (A Group)		Group II (B Group)		Group III (C Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/31 (0%)		0/31 (0%)
Serious Adverse Events
	Group I (A Group)		Group II (B Group)		Group III (C Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/31 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Group I (A Group)		Group II (B Group)		Group III (C Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/31 (0%)		0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.