Erector Spinae vs TAP in Lower Abdominal Surgery

Postoperative Pain Clinical Trial

Official title:

Comparison Between Ultrasound-Guided Transversus Abdominis Plane Block and Ultrasound-Guided Erector Spinae Plane Block in Postoperative Analgesia for Lower Abdominal Cancer Surgery. Randomised Double Blinded Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04555993
• Other study ID #: MS-39-2019
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: October 15, 2020

Study information

• Verified date: September 2020
• Source: National Cancer Institute, Egypt
• Contact: ahmed hasanin, Professor
• Phone: +201095076954
• Email: ahmedmohamedhasanin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: October 15, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• lower abdominal surgery
Patients will undergo lower abdominal surgery under general anesthesia.

Other:
• Erector spinae plane block
patients will receive erector spinae plane block using 20 mL levobupivacaine (0.25%).
• Transversus abdominis plane block
patients will receive transversus abdominis plane block using 20 mL levobupivacaine (0.25%).

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative nausea and vomiting	the number of patients who had nausea and vomiting	24 hours postoperative
Other	Time for first rescue analgesia.	the time at which the patient will request an analgesic	24 hours postoperative
Other	Heart rate	the number of heart beats in one minute	24 hours
Other	Numerical rating scale for pain assessment.	This is a numerical rating scale for pain assessment which ranges from 0 to 10 with the least pain at scale 0 and the worst pain at scale 10	24 hours
Other	mean arterial blood pressure	the mean arteiral blood pressure measurend in mmHg	24 hours
Primary	Total morphine consumption	The total amount of morphine which was consumed post-operatively measured in milligrams	24 hours
Secondary	Intraoperative fentanyl consumption.	The total amount of fentanyl which was consumed during the surgery measured in milligrams	intraoperative