Comparison Of Erector Spinae Plane Block With Transversus Abdominis Plane Block For Postoperative Pain Management In Patients Undergoing Total Abdominal Hysterectomy

NCT05521841 | Unknown

• 1 other identifier: 92(6-11)F2
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hysterectomy is the second most common major Obstetric/gynecology procedure worldwide and one of the most common procedures in our institute. Post-operative pain is one of the most common complications following hysterectomy. Patients report moderate to severe pain following hysterectomy. Transversus abdominis plane block(TAP) is an established technique for abdominal and pelvic analgesia. Although efficient as an analgesic technique, it lacks visceral analgesia.Erector spinae plane block (ESP) is one of the newer developed regional techniques. Initially developed for Thoracic Neuropathic Pain by Forero et al, its use has expanded to include thoracic, abdominal and even femoral and below knee operative pain management. Objective: The objective of this study is to compare the ESP block with the TAP block for postoperative pain management in cases undergoing Total abdominal hysterectomy. Methods: A hospital based randomized, prospective, interventional study will be performed on all consenting patients undergoing total abdominal hysterectomy under general anesthesia. The required number of participants will be selected by probability sampling. Fourty four female participants posted for elective Total abdominal hysterectomy under general anesthesia will be randomized onto two groups. The process of randomisation will be via computer generated randomization sequence.Each of the group will receive either of the two intervention after the completion of operative procedure. The post operative anelgesia duration and NRS score will be compared between the two groups. Approval will be taken from the Institutional Review Committee (IRC) of Institute of Medicine. Written consent will be taken prior to the data collection. Data will be entered in Microsoft Excel and errors will be checked. The clean data will be transferred into SPSS v 20 for analysis The results will be presented in terms of frequency percentage and table The associations will be established.

Conditions

Pain, Postoperative

Keywords

Pain, Postoperative; Postoperative analgesia; ESP block; TAP block; TAH

Outcome Measures

Primary Outcomes (1)

• Time of first rescue analgesia within 24hours

  Rescue analgesia used injection Tramadol, given if Numerical rating score(NRS) \>3 withing 24hours of the procedure.

  24hours

Secondary Outcomes (3)

• Total amount of rescue analgesia.

  24hours

• Pain assessment at set time

  24hours

• Comparision of side effect: Incidence of Respiratory depression,Incidence of sedation, motor block, postoperative nausea and vomiting postoperative nausea and vomiting of intervention

  24hours

Study Arms (2)

Erector Spinae Plane Block

EXPERIMENTAL

Bilateral Ultrasound Guided Erector Spinae Plane Block

Procedure: Erector Spinae Plane Block(Bilateral Ultrasound Guided Erector Spinae Plane Block)

Transversus abdominis plane block

ACTIVE COMPARATOR

Bilateral Ultrasound-guided bilateral Transversus abdominis plane block

Procedure: Transversus abdominis plane block(Bilateral Ultrasound-guided bilateral Transversus abdominis plane block)

Interventions

Erector Spinae Plane Block(Bilateral Ultrasound Guided Erector Spinae Plane Block) PROCEDURE

Bilateral USG guided Erector Spinae Plane Block: Drug used 20 ml of 0.25% Bupivacaine in each side. Total 40 ml volume. Dosage 100mg Ultrasound transducer will be placed in a cephalocaudal orientation over the back at 10th thoracic vertebral level. The probe will then slowly be moved laterally until the transverse process is visible The trapezius muscle and erector spinae muscle will be identified as superficial to the transverse process. A 25-gauge Quincke spinal needle (Romsons spinal needle, Quincke type)will be inserted using an in-plane approach in the cephalad to the caudal direction and towards the transverse process. A 5ml bolus of local anesthetic will be given. Erector spinae muscle plane is then visualized separating from the transverse process. The local anesthetic is then injected in 5 ml increments, with aspiration after every 5 ml to avoid intravascular injection Same procedure will be repeated on the other side

Also known as: ESP

Erector Spinae Plane Block

Transversus abdominis plane block(Bilateral Ultrasound-guided bilateral Transversus abdominis plane block) PROCEDURE

Bilateral Ultrasound-guided bilateral Transversus abdominis plane block Drug used 20 ml of 0.25% Bupivacaine in each side. Total 40 ml volume. Dosage 100mg The linear transducer will be placed in the transverse plane at the lateral abdominal wall in the mid-axillary line, between the lower costal margin and the iliac crest. Abdominal wall muscles (external oblique, internal oblique, and transversus abdominis) will be visualized. Bowel movement and visualization of hypoechoic peritoneum would further guide the block. The needle will be inserted in-plane and advanced until the tip is between the internal oblique and the transversus abdominis muscle. After negative aspiration, 20 mL of 0.25% bupivacaine is injected in a 5ml increment ,aspirating after every 5ml injection. Same procedure will be repeated on the other side.

Also known as: TAP

Transversus abdominis plane block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All cases undergoing total abdominal hysterectomy under GA
• Age \>18 years
• Elective cases
• ASA PS I \& II

You may not qualify if:

• Patient refusal
• Patient with contraindication to peripheral Nerve blocks
• Allergy to local anesthetics
• Weight less than 50kg

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead

Related Publications (16)

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  PMID: 17978124 BACKGROUND

• Lissauer J, Mancuso K, Merritt C, Prabhakar A, Kaye AD, Urman RD. Evolution of the transversus abdominis plane block and its role in postoperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Jun;28(2):117-26. doi: 10.1016/j.bpa.2014.04.001. Epub 2014 May 9.

  PMID: 24993433 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• Kamel AAF, Amin OAI, Ibrahem MAM. Bilateral Ultrasound-Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block on Postoperative Analgesia after Total Abdominal Hysterectomy. Pain Physician. 2020 Jul;23(4):375-382.

  PMID: 32709172 BACKGROUND

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  PMID: 27364392 BACKGROUND

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• Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603.

  PMID: 31033625 BACKGROUND

• Boules ML, Goda AS, Abdelhady MA, Abu El-Nour Abd El-Azeem SA, Hamed MA. Comparison of Analgesic Effect Between Erector Spinae Plane Block and Transversus Abdominis Plane Block After Elective Cesarean Section: A Prospective Randomized Single-Blind Controlled Study. J Pain Res. 2020 May 19;13:1073-1080. doi: 10.2147/JPR.S253343. eCollection 2020.

  PMID: 32547172 BACKGROUND

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  PMID: 30621377 BACKGROUND

• American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.

  PMID: 22227789 BACKGROUND

• Hamed MA, Goda AS, Basiony MM, Fargaly OS, Abdelhady MA. Erector spinae plane block for postoperative analgesia in patients undergoing total abdominal hysterectomy: a randomized controlled study original study. J Pain Res. 2019 Apr 30;12:1393-1398. doi: 10.2147/JPR.S196501. eCollection 2019.

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• Altinpulluk EY, Ozdilek A, Colakoglu N, Beyoglu CA, Ertas A, Uzel M, Yildirim FG, Altindas F. Bilateral postoperative ultrasound-guided erector spinae plane block in open abdominal hysterectomy: a case series and cadaveric investigation. Rom J Anaesth Intensive Care. 2019 Apr;26(1):83-88. doi: 10.2478/rjaic-2019-0013.

  PMID: 31111101 BACKGROUND

• Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.

  PMID: 19020158 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Biplov Neupane, MBBS

CONTACT

9818752077; bclub13@gmail.com

Basu Dev Parajuli, MBBS, MD

CONTACT

9851179038; bashuparajuli2012@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Department of Anesthesiology, Tribhuvan University Teaching Hospital, Institute Of Medicine.

Model Details: hospital based randomized, prospective, interventional study

Study Record Dates

• First Submitted: August 27, 2022
• First Posted: August 30, 2022
• Study Start: November 10, 2022
• Primary Completion: April 10, 2023
• Study Completion: August 10, 2023
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share