Post-c-section Pain Control Satisfaction with Erector Spinae Simple Block Vs Lateral Quadratus Lumborum Block

NCT06771466 | Not Yet Recruiting DMC

• 1 other identifier: FMASU R254/2024
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The study will compare the difference between the patient's satisfaction after Erector spinae plane block (ESP) and Quadratus Lumborum block lateral approach after caesarean section alone or as part of multimodal analgesia. The primary outcome is to test whether the type of plane block has an implication on the patients' satisfaction. The secondary outcome is to test the difference between the two approaches on the hospital discharge

Conditions

Satisfaction; Pain Management After Surgery

Keywords

nerve block, pain, opioids, patient satisfaction, cesarean section

Outcome Measures

Primary Outcomes (1)

• To test whether the type of the plane block have an implication on the patients' satisfaction.

  The patient's satisfaction with the block will be measured using a 4-point Likert assessment to the question, "Are you satisfied with the pain management done after the cesarean section?" totally disagree, disagree, agree, totally agree.

  first 24 hours after the surgery

Secondary Outcomes (1)

• to test the difference between the two approaches on the hospital discharge

  24-48 hours after the surgery

Study Arms (2)

Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E)

ACTIVE COMPARATOR

those will receive Bilateral ultrasound-guided low thoracic Erector spinae plane block at a level of T9 with a total volume of 60 ml of bupivacaine 0.3% and Dexmedetomidine at a total dose of 0.5 mcg/kg

Procedure: Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E)

Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q)

SHAM COMPARATOR

Those patients will receive Bilateral ultrasound-guided Quadratus Lumborum, Lateral approach with a total volume of 60 ml of bupivacaine 0.3% and Dexmedetomidine at a total dose of 0.5 mcg/kg.

Procedure: Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q)

Interventions

Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E) PROCEDURE

The curvilinear ultrasound transducer should be placed in a cephalocaudal orientation over the midline of the back at the desired level. The probe should then slowly be moved laterally until the transverse process is visible. The transverse process requires differentiation from the rib at that level. The transverse process will be more superficial and wider, while the rib will be deeper and thinner. Upon verification of the transverse process, the trapezius muscle, rhomboid major muscle (if performing at T5 level or higher), and erector spinae muscle should be identified superficial to the transverse process. The Tuohy needle should be inserted superior to the ultrasound probe using an in-plane approach in the cephalad to caudal direction.

Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E)

Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q) PROCEDURE

With the patient positioned in the lateral position, scanning is usually started at the mid-axillary line between the iliac crest and subcostal margin, moving the probe posteriorly until tapering of the three abdominal muscle layers and appearance of fascia transversalis and QL muscle are observed. The fascia transversalis usually appears as a hyperechoic layer, which forms a safe landmark to separate the muscle layers from the peri-nephric fat and the abdominal contents

Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q)

Eligibility Criteria

• Age: Up to 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Parturient female
• Scheduled for elective cesarean section

You may not qualify if:

• Known allergy to any of the medications used
• Patients refused to participate in the study
• Patients with emergency section,
• Patients with Bleeding disease
• Patients with postpartum haemorrhage

Sponsors & Collaborators

• Wael Sayed El Gharabawy: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt, 11728, Egypt

Location

Related Publications (6)

• Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.

  PMID: 20142348 BACKGROUND

• Sutton CD, Carvalho B. Optimal Pain Management After Cesarean Delivery. Anesthesiol Clin. 2017 Mar;35(1):107-124. doi: 10.1016/j.anclin.2016.09.010. Epub 2016 Dec 12.

  PMID: 28131114 BACKGROUND

• Wikner M. Unexpected motor weakness following quadratus lumborum block for gynaecological laparoscopy. Anaesthesia. 2017 Feb;72(2):230-232. doi: 10.1111/anae.13754. Epub 2016 Nov 28.

  PMID: 27891579 BACKGROUND

• Ribeiro Junior IDV, Carvalho VH, Brito LGO. Erector spinae plane block for analgesia after cesarean delivery: a systematic review with meta-analysis. Braz J Anesthesiol. 2022 Jul-Aug;72(4):506-515. doi: 10.1016/j.bjane.2021.09.015. Epub 2021 Oct 18.

  PMID: 34673125 BACKGROUND

• Priya TK, Singla D, Talawar P, Sharma RS, Goyal S, Purohit G. Comparative efficacy of quadratus lumborum type-II and erector spinae plane block in patients undergoing caesarean section under spinal anaesthesia: a randomised controlled trial. Int J Obstet Anesth. 2023 Feb;53:103614. doi: 10.1016/j.ijoa.2022.103614. Epub 2022 Dec 6.

  PMID: 36535864 BACKGROUND

• Yu L, Shen X, Liu H. The effect and safety of dexmedetomidine as an adjuvant to local anesthetics in erector spinae plane block: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2023 Feb 27;23(1):61. doi: 10.1186/s12871-023-02019-x.

  PMID: 36849910 BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction; Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Wael S El Gharabawy, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wael S algharabawy, MD

CONTACT

00201096973949; gharabawy76@med.asu.edu.eg

waleed Y youssef, MD

CONTACT

00201006305703; gharabawy76@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The patient will be blind to the technique he will receive, and the care giver will be unaware of the block the patient being cared for received. Furthermore, the outcomes assessor, who is in charge of collecting the data, has no idea who received which block.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assisstant professor of Anesthesia, Intensive care, and Pain management

Model Details: To investigate the difference in patient satisfaction following Erector spinae plane block (ESP) and Quadratus Lumborum block lateral approach after caesarean surgery, either alone or as part of multimodal analgesia.

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 13, 2025
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)