Analgesia of Erector Spinae Plane Block Versus Quadratus Lumborum Block

NCT ID: NCT03803267

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-04-01

Brief Summary

Colorectal cancer is the third most common cancer worldwide. These patients usually undergo open surgical resection of cancer under general anaesthesia.

The aim of this study is to detect whether the Erector spinae plan block or Quadratus lumborum block will provide the most ideal analgesia for these patients. Erector spinae plan block is a novel analgesic technique that provides both visceral and somatic analgesia due to its communication with the paravertebral space. Quadratus lumborum block is a truncal nerve block usually used for intra-abdominal surgeries. Ultrasound guidance increases the accuracy and safety of both techniques. A local anaesthetic mixture of Bupivacaine 0.25% and dexamethasone will be used for both techniques.

Detailed Description

Erector spinae plane block and quadratus lumborum block are analgesic techniques suitable for open colorectal cancer surgeries. postoperative pain score, serum levels of biomarkers of stress (cortisol and CRP), primary hemodynamics, time to first rescue analgesic request, the total amount of rescue analgesic consumption and postoperative nausea and vomiting are the parameters of comparison between both techniques.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Erector spinae plane block

Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique

Group Type: ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type: OTHER

For each side, the eighth thoracic transverse process will be identified by a linear US transducer (HFL38\_10-5 MHz), puncture will be performed in the plane in the craniocaudal direction until the needle contacts the transverse process, and 20 ml of bupivacaine 0.25% and 4 mg dexamethasone will be injected visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesirable motor weakness will be recorded as a side effect.

Propofol

Intervention Type: DRUG

Propofol (2 mg/kg)

Fentanyl NCS

Intervention Type: DRUG

Fentanyl (1µg/Kg)

Atracurium Injectable Product

Intervention Type: DRUG

atracurium (0.5mg/kg)

Endotracheal intubation

Intervention Type: OTHER

endotracheal intubation

Anesthesia Maintenance

Intervention Type: DRUG

Inhalational isoflurane in oxygen/air mixture

Muscle Relaxation

Intervention Type: DRUG

atracurium boluses (0.2 mg/Kg/20 minutes) will be used for maintenance of general anesthesia

Quadratus lumborum block

Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique

Group Type: ACTIVE_COMPARATOR

Quadratus lumborum block

Intervention Type: OTHER

For each side, shamrock sign with three leaves (psoas major muscle anteriorly, the erector spinae muscle posteriorly and the quadratus lumborum muscle adherent to the apex of the transverse process of the L4 vertebral body) will be identified by a curved array US transducer (6-2MHz), puncture will be performed in-plane, the needle will be advanced through the quadratus lumborum muscle penetrating the ventral proper fascia of the quadratus lumborum muscle, and 20 mL of bupivacaine 0.25% and 4 mg dexamethasone will be injected in that space visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesired motor weakness will be recorded as a side effect

Propofol

Intervention Type: DRUG

Propofol (2 mg/kg)

Fentanyl NCS

Intervention Type: DRUG

Fentanyl (1µg/Kg)

Atracurium Injectable Product

Intervention Type: DRUG

atracurium (0.5mg/kg)

Endotracheal intubation

Intervention Type: OTHER

endotracheal intubation

Anesthesia Maintenance

Intervention Type: DRUG

Inhalational isoflurane in oxygen/air mixture

Muscle Relaxation

Intervention Type: DRUG

atracurium boluses (0.2 mg/Kg/20 minutes) will be used for maintenance of general anesthesia

Interventions

Erector spinae plane block

For each side, the eighth thoracic transverse process will be identified by a linear US transducer (HFL38\_10-5 MHz), puncture will be performed in the plane in the craniocaudal direction until the needle contacts the transverse process, and 20 ml of bupivacaine 0.25% and 4 mg dexamethasone will be injected visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesirable motor weakness will be recorded as a side effect.

Intervention Type: OTHER

Quadratus lumborum block

For each side, shamrock sign with three leaves (psoas major muscle anteriorly, the erector spinae muscle posteriorly and the quadratus lumborum muscle adherent to the apex of the transverse process of the L4 vertebral body) will be identified by a curved array US transducer (6-2MHz), puncture will be performed in-plane, the needle will be advanced through the quadratus lumborum muscle penetrating the ventral proper fascia of the quadratus lumborum muscle, and 20 mL of bupivacaine 0.25% and 4 mg dexamethasone will be injected in that space visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesired motor weakness will be recorded as a side effect

Intervention Type: OTHER

Propofol

Propofol (2 mg/kg)

Intervention Type: DRUG

Fentanyl NCS

Fentanyl (1µg/Kg)

Intervention Type: DRUG

Atracurium Injectable Product

atracurium (0.5mg/kg)

Intervention Type: DRUG

Endotracheal intubation

endotracheal intubation

Intervention Type: OTHER

Anesthesia Maintenance

Inhalational isoflurane in oxygen/air mixture

Intervention Type: DRUG

Muscle Relaxation

atracurium boluses (0.2 mg/Kg/20 minutes) will be used for maintenance of general anesthesia

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists physical status I or II
• Body mass index from 18.5 to 35 Kg/m2

Exclusion Criteria

• Body mass index more than 35 Kg/m2.
• Severe or uncompensated cardiovascular disease.
• Severe renal disease.
• Severe hepatic disease.
• Severe endocrinal disease.
• Pregnancy.
• Postpartum.
• Lactating females
• Allergy to one of the agents used.
• Refusal to participate in the study.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amer A Attieh, MD

Role: STUDY_CHAIR

Professor

Mohammed A Ghanem, MD

Role: STUDY_DIRECTOR

Associate Professor

Locations

Amer A Attieh

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

MD.18.11.106

Identifier Type: -

Identifier Source: org_study_id