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Transversus Abdominis Plane Block Versus Erector Spinae Plane Block

Ultrasound Guided Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Patients Undergoing Emergency Laparotomies.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03989570
Enrollment
100
Registered
2019-06-18
Start date
2019-05-15
Completion date
2020-02-12
Last updated
2020-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparotomy, Postoperative Pain

Keywords

Erector Spinae Plane Block, Transversus Abdominis Plane Block

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 .

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

Interventions

PROCEDUREtransversus 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

PROCEDUREerector 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

OTHERcontrol group

placebo

Sponsors

Hassan Mokhtar Elshorbagy Hetta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Time of First Post Operative Analgesic Request24 hoursthe pain will be assisted based on the time for the first dose of rescue analgesia
Postoperative Total Fentanyl Requirement24 hoursThe total amount of postoperative fentanyl in milligram was given to the patient as rescue analgesia during 24 hours

Secondary

MeasureTime frameDescription
Incidence of Any Adverse Events5 daysadverse events related to technique or drugs

Countries

Egypt

Participant flow

Pre-assignment details

7 patient refuse to participate

Participants by arm

ArmCount
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). 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
31
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). 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
Group III (C Group)
31 patients anesthetized with the protocol followed by Minia University Hospital control group: placebo
31
Total93

Baseline characteristics

CharacteristicGroup I (A Group)TotalGroup III (C Group)Group II (B Group)
Age, Continuous45.8 years
STANDARD_DEVIATION 14.9
45.61 years
STANDARD_DEVIATION 13.46
43.6 years
STANDARD_DEVIATION 13.7
47.4 years
STANDARD_DEVIATION 11.8
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
31 Participants93 Participants31 Participants31 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
31 Participants93 Participants31 Participants31 Participants
Region of Enrollment
Egypt
31 participants93 participants31 participants31 participants
Sex: Female, Male
Female
15 Participants45 Participants16 Participants14 Participants
Sex: Female, Male
Male
16 Participants48 Participants15 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 310 / 31
other
Total, other adverse events
0 / 310 / 310 / 31
serious
Total, serious adverse events
0 / 310 / 310 / 31

Outcome results

Primary

Postoperative Total Fentanyl Requirement

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

Time frame: 24 hours

ArmMeasureValue (MEAN)Dispersion
Group I (A Group)Postoperative Total Fentanyl Requirement40.3 MilligramStandard Deviation 26.7
Group II (B Group)Postoperative Total Fentanyl Requirement111 MilligramStandard Deviation 38.1
Group III (C Group)Postoperative Total Fentanyl Requirement175 MilligramStandard Deviation 38.9
Primary

Time of First Post Operative Analgesic Request

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

Time frame: 24 hours

ArmMeasureValue (MEAN)Dispersion
Group I (A Group)Time of First Post Operative Analgesic Request14.9 HourStandard Deviation 5.7
Group II (B Group)Time of First Post Operative Analgesic Request6.5 HourStandard Deviation 2.2
Group III (C Group)Time of First Post Operative Analgesic Request2.8 HourStandard Deviation 1.6
Secondary

Incidence of Any Adverse Events

adverse events related to technique or drugs

Time frame: 5 days

ArmMeasureValue (NUMBER)
Group I (A Group)Incidence of Any Adverse Events0 participants
Group II (B Group)Incidence of Any Adverse Events0 participants
Group III (C Group)Incidence of Any Adverse Events0 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026