Erector Spinae vs TAP in Lower Abdominal Surgery

NCT ID: NCT04555993

Last Updated: 2020-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-28

Study Completion Date

2020-10-15

Brief Summary

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The aim of this study is to compare the analgesic effect and safety profile of erector spinae plane block with transverses abdominis plane block in controlling peri-operative pain for lower abdominal cancer surgery.

Detailed Description

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Pain triggers a complex biochemical and physiological stress response leading to impairment of pulmonary, immunological and metabolic functions. Opioids are the current gold standard drug for postoperative pain relief, however exposure to large doses lead to multiple side effects of varying significance such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and sleep breathing disorders. Therefore strategies other than opioids are recommended without sacrificing proper and effective analgesia. Especially in cancer patients who are more susceptible to tolerance and addiction.

The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used effectively in laparotomies. Unilateral analgesia to the skin, muscles, and parietal peritoneum of the anterior abdominal wall will be achieved without affecting visceral pain, when the anterior rami of the lower six thoracic nerves (T7-T12) and the first lumbar nerve (L1) are blocked.

Erector spinae plane block (ESPB) was shown to be an effective analgesic option for different types of surgeries. It's relatively a simple block, drug is injected in the plane between the erector spinae muscle and the vertebral transverse process. Blocking the ventral and dorsal rami of spinal nerves on the paravertebral area distributed from T2-T4 to L1-L2 and gives good coverage to visceral pain. Owing to the lower risk of blood vessel damage and neural damage compared to the epidural or the paravertebral block.

Both blocks haven't been compared to each other in this type of surgery before.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Transversus abdomis plane block

Patients will receive Transversus abdomis plane block

Group Type ACTIVE_COMPARATOR

lower abdominal surgery

Intervention Type PROCEDURE

Patients will undergo lower abdominal surgery under general anesthesia.

Transversus abdominis plane block

Intervention Type OTHER

patients will receive transversus abdominis plane block using 20 mL levobupivacaine (0.25%).

Erector spinae plane block

Patients will receive Erector spinae plane block.

Group Type EXPERIMENTAL

lower abdominal surgery

Intervention Type PROCEDURE

Patients will undergo lower abdominal surgery under general anesthesia.

Erector spinae plane block

Intervention Type OTHER

patients will receive erector spinae plane block using 20 mL levobupivacaine (0.25%).

Interventions

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lower abdominal surgery

Patients will undergo lower abdominal surgery under general anesthesia.

Intervention Type PROCEDURE

Erector spinae plane block

patients will receive erector spinae plane block using 20 mL levobupivacaine (0.25%).

Intervention Type OTHER

Transversus abdominis plane block

patients will receive transversus abdominis plane block using 20 mL levobupivacaine (0.25%).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Physical status ASA II.
* Age ≥ 18 and ≤ 65 Years.
* Cancer patients undergoing laparotomies for radical cystectomy or radical hysterectomy or low anterior resection (lower abdominal procedures).
* Patient is able to provide a written informed consent.
* Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2.

Exclusion Criteria

* Age \<18 years or \>65 years.
* BMI \<20 kg/m2 and \>40 kg/m2.
* Known sensitivity to local anaesthetics and morphine.
* History of psychological disorders and/or chronic pain.
* Significant liver or renal insufficiency.
* Contraindication to regional anaesthesia e.g. local sepsis, preexisting peripheral neuropathies and coagulopathy.
* Patient refusal.
* Severe respiratory or cardiac disorders.
* Pregnancy.
* ASA III-IV.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Shaban Mohammed

Assistant lecturer of anesthesia and critical care medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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waleed hamimy, Professor

Role: STUDY_CHAIR

Cairo University

Locations

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National Cancer Institute

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ahmed hasanin, Professor

Role: CONTACT

+201095076954

ahmed zaghloul, Professor

Role: CONTACT

00201001839591

References

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Randerath WJ, George S. Opioid-induced sleep apnea: is it a real problem? J Clin Sleep Med. 2012 Oct 15;8(5):577-8. doi: 10.5664/jcsm.2162. No abstract available.

Reference Type BACKGROUND
PMID: 23066371 (View on PubMed)

Finnerty O, Carney J, McDonnell JG. Trunk blocks for abdominal surgery. Anaesthesia. 2010 Apr;65 Suppl 1:76-83. doi: 10.1111/j.1365-2044.2009.06203.x.

Reference Type BACKGROUND
PMID: 20377549 (View on PubMed)

Hebbard P. Subcostal transversus abdominis plane block under ultrasound guidance. Anesth Analg. 2008 Feb;106(2):674-5; author reply 675. doi: 10.1213/ane.0b013e318161a88f. No abstract available.

Reference Type BACKGROUND
PMID: 18227342 (View on PubMed)

Yarwood J, Berrill A (2010). Nerve blocks of the anterior abdominal wall, Continuing Education in Anaesthesia Critical Care & Pain, Vol10, Issue 6, pp 182-186.

Reference Type BACKGROUND

Abrahams MS, Horn JL, Noles LM, Aziz MF. Evidence-based medicine: ultrasound guidance for truncal blocks. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S36-42. doi: 10.1097/AAP.0b013e3181d32841.

Reference Type BACKGROUND
PMID: 20216023 (View on PubMed)

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

Reference Type BACKGROUND
PMID: 27501016 (View on PubMed)

Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.

Reference Type BACKGROUND
PMID: 28188621 (View on PubMed)

Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.

Reference Type BACKGROUND
PMID: 28252539 (View on PubMed)

De Cassai A, Marchet A, Ori C. The combination of erector spinae plane block and pectoralis blocks could avoid general anesthesia for radical mastectomy in high risk patients. Minerva Anestesiol. 2018 Dec;84(12):1420-1421. doi: 10.23736/S0375-9393.18.13031-8. Epub 2018 Jul 9. No abstract available.

Reference Type BACKGROUND
PMID: 29991225 (View on PubMed)

Other Identifiers

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MS-39-2019

Identifier Type: -

Identifier Source: org_study_id

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