Erector Spinae Plane Block Versus TAP Block for Postoperative Analgesia of Laparoscopic Appendectomy

January 29, 2024 updated by: Eman abdelnaby Mohamed soliman, Ain Shams University

Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia of Adult Patients Undergoing Laparoscopic Appendectomy

Laparoscopic appendectomy is the most frequently performed surgery in patients who develop acute appendicitis. This surgical technique is more advantageous than an open appendectomy in terms of fewer complications, less postoperative pain, and a faster return to normal daily activities. Even though the laparoscopic technique is minimally invasive, postoperative pain is inevitable. Furthermore, it may affect the patients' mobility and cause them to stay in the hospital for a more extended period .The study aimed to compare the effectiveness and the safety of ultrasound-guided erector spinae plane block versus ultrasound-guided transversus abdominis plane block (TAP) as postoperative analgesia methods after laparoscopic appendectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Acute appendicitis develops in a progressive and irreversible manner, even if the clinical course of acute appendicitis can be temporarily modified by intentional medications. Reliable and real-time diagnosis of acute appendicitis can be made based on findings of the white blood cell count and enhanced computed tomography. Emergent laparoscopic appendectomy is considered as the first therapeutic choice for Acute appendicitis .

The reported advantages of laparoscopic appendectomy compared with open appendectomy are less postoperative pain, less wound infection, and better cosmetic results. Even though the laparoscopic technique is minimally invasive, postoperative pain is inevitable. Furthermore, it may affect the patients' mobility and cause them to stay in the hospital for a more extended period .An intraperitoneal injection of local anesthetics is one of the analgesic modalities that are used to control pain in such cases but it is insufficient analgesic in most of patients and has short duration effect .

Recently Ultrasound-guided nerve blocks were effectively used for postoperative analgesia in different types of surgical procedures .Both erector spinae plane block and oblique subcostal transversus abdominis plane block have been used effectively to reduce pain after laparoscopic appendectomy.

In ultrasound-guided Transversus Abdominis Plane (TAP) Block local anesthetic (LA) is deposited in the plane between the transversus abdominis and posterior sheath of the rectus muscle in approximately midway between the iliac crest and costal margin .To anesthetize The terminal branches of the lower six thoracic and first lumbar nerve lie within, providing analgesia of the anterior and lateral abdominal wall .This block has a low risk for serious complications such as bowel or diaphragm perforation and lacerations of the liver. Abdominal wall hematoma, vascular injury, and local anesthetic toxicity are also potential but rare complications . Owing to safety of ultrasound-guided needle placement a 'real-time' visualization through dynamic scanning is used .

The ultrasound-guided Erector Spinae Plane (ESP) block is a paraspinal fascial plane block in which local anesthetic is administered between the erector spinae muscle and the thoracic transverse processes at the levels of the T7-T9 transverse processes, resulting in spread between the T6 and T12 segmental levels, blocking the dorsal and ventral rami of the abdominal spinal nerves.

This blockage of the dorsal and ventral rami of the spinal nerves helps to achieve a multi-dermatomal sensory block of the anterior, posterior, and lateral abdominal walls.

ESP block Complications such as vascular puncture, pleural puncture and pneumothorax are the primary complications .Also local anethetic toxicity, infection at needle insertion site and allergy also can occur .

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohamed Abd Elmawla, MD
  • Phone Number: 01092847049
  • Email: ozmolq@gmail.com

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University Hospitals
        • Contact:
        • Sub-Investigator:
          • Engy sami, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients scheduled for laparoscopic appendectomy,
  • Patients aged 18-50 years,
  • American Society of Anaesthesiologists (ASA) physical status I or II.

Exclusion Criteria:

  • Declined informed consent.
  • Allergy to local anesthetics.
  • Conversion of the laparoscopic surgery to open appendectomy.
  • Coagulation disorder.
  • Pregnancy,
  • BMI more than 40 kg/m2,
  • Respiratory disease, liver or kidney disease; and heart disease (heart block, Rheumatic heart or myocardial ischemia).
  • Psychiatric problems, that results in lack of communication ability.
  • Chronic alcoholism, drug abuse,
  • Infection in the area where the block will be applied.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (ESP) block group
the first group (ESP) will be placed in the lateral decubitus position. The ultrasound probe will be placed in longitudinal orientation at the level of the T7 spinous process and then moved the probe 3 cm laterally from the midline. The ultrasound landmarks, which included the T7 transverse process and the overlying erector spinae muscle, will be identified. Under complete aseptic conditions, an 80-mm 21-gauge block needle will be inserted in plane at an angle of 30-40° in cranial-to-caudal direction until the tip contacted the T7 transverse process. After hydro-dissection with 3 mL of isotonic saline solution confirmed the correct needle tip position, 30 mL of 0.25% bupivacaine and dexamethasone 4mg will be injected deep to the erector spinae muscle. The same procedure will be repeated with 30 mL of 0.25% bupivacaine solution and dexamethasone 4mg on the contralateral side.
Procedure: erector spinae plane block (ESP)
patients will receive Ultrasound-guided erector spinae plane block (ESP) block for postoperative analgesia of adult patients undergoing laparoscopic appendectomy.
Active Comparator: Group B TAP block group
patients who will receive TAP block. A high-frequency ultrasound probe placed transversely, approximately midway between the iliac crest and costal margin shows the three muscle layers of the abdominal wall. A regional block needle can then be inserted anteriorly and slightly away from the probe and carefully advanced until it reaches the transversus plane. In this 'in-plane' technique. The needle and its tip are visualised throughout the procedure, as it enters the transversus plane after piercing the fascial layer below the internal oblique muscle. The needle will be directed toward the transversus abdominis fascia and injected 30 mL of 0.25% bupivacaine and dexamethasone 4mg between the rectus abdominis and transversus abdominis muscles. The same procedure will be repeated with 30 mL of 0.25% bupivacaine solution and dexamethasone 4mg on the contralateral side.
Procedure: transversus abdominis plane block(TAP)
patients will receive Ultrasound-guided transversus abdominis plane block(TAP) Block for postoperative analgesia of adult patients undergoing laparoscopic appendectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
a numerical rating scale (NRS)
Time Frame: Patients will be asked to record their level of pain at 30 minutes as well as at two, four, six, eight, 12, 18 and 24 hours postoperatively.
an 11-point scale where 0 indicates no pain and 10 indicates the worst imaginable pain. Patients will chose a whole number to express the degree of their pain both at rest and when moving.
Patients will be asked to record their level of pain at 30 minutes as well as at two, four, six, eight, 12, 18 and 24 hours postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative heart rate
Time Frame: the duration of surgery
Heart rate (HR)in beat per minute will be recorded every 5 min till the end of the surgery.
the duration of surgery
Incidence of complications
Time Frame: the duration of surgery
Including nerve injury, hematoma formation, Local anesthetic toxicity, and intravascular injections;
the duration of surgery
the cumulative consumption of pethidine
Time Frame: the first 24 postoperatively
At a NRS pain scores of four or above, 50 mg of intravenous pethidine was administered. The total dose of analgesics administered during the first 24 hours will be carefully recorded.
the first 24 postoperatively
The duration of time before the first request for rescue analgesia post-surgically.
Time Frame: first postoperative hour
The maximum allowed dose of pethidine will be set at 5 mg/kg/24 h based on lean body weight. The blocks will be considered as failed blocks if patients require more than two doses of rescue analgesia in the first postoperative hour.
first postoperative hour
intraoperative blood pressure monitoring
Time Frame: the duration of surgery
mean arterial pressure (MAP) in millimeter mercury will be recorded every 5 min till the end of the surgery.
the duration of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Amira Fathy, MD, Ainshams university
  • Study Chair: Mohsen Basyoni, MD, Ainshams university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

January 6, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • laparoscopic appendectomy pain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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