Erectae Spinae Block Versus Intrathecal Morphine for Postoperative Analgesis in Lumbar Surgeries

NCT05123092 | Completed DMC

• 1 other identifier: M520
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The study design will be double blinded retrospective controlled comparative study. The patients will be included in the study shoud be in the following category:

• American Society of Anesthesiologists (ASA) physical status I, II
• Age range from 18 and 70 years. The patients will be discarded from the study shoud be in the following:
• patient refusal.
• significant renal, hepatic and cardiovascular diseases.
• Pregnancy.
• Any contraindication to regional anesthesia such as local infection or bleeding disorders.
• Chronic opioid use, history of chronic pain and cognitive disorders.
• Lumbar spine lesion revision and dural tear. Postoperative pain will be evaluated using a visual analogue scale (VAS) score as primary outcome measure. demographic data ( Age, Weight, sex and height) , ASA classification ,mean operative times (min), time to the first rescue analgesic (min) ,intraoperative fentanyl consumption(microgram),postoperative opioid consumption ,sedation score, hemodynamics intraoperative and postoperative ( BP ,H R and oxgen saturation %) and complications as 2ry outcome measures.

Conditions

Post-operative; Analgesia

Keywords

Ultrsound; Intrathecal; Morphine; Erectae spinae

Outcome Measures

Primary Outcomes (1)

• VAS score

  The mean VAS score (score 0 =no pain and 10 =worst pain ever ) in the two groups of the study.

  Every 4 bours for 48 hours post operative

Secondary Outcomes (12)

• Age

  Day 1

• Gender

  Day 1

• Height

  Day 1

• Weight

  Day 1

• Body Mass Index

  Day 1

Study Arms (2)

Group ( ultrasound guided erectae spinae block)

ACTIVE COMPARATOR

The same anesthesiologist who is experienced in US guided regional anesthesia will perform the block. In the group ESP, a high frequency linear US probe (HFL\_50, 15\_6MHz) will be placed vertically and nearly 3 cm lateral to the vertebra in the middle of the incision line. The transverse process and the overlaying erector spinae muscles (ESM) will be identified under parasagittal scanning A22 G,50 mm block needle (SONOTAP,Pajunk, Geisingen,Germany) will be inserted at a 30-40° angle in the cranial to caudal direction via an in-plane approach and advanced into the plane between the fascia of ESM and transverse process under sterile conditions. The correct needle position will be confirmed after a hydro dissection with 3 ml of isotonic saline, and then 20 ml of 0.25% bupivacaine will be injected in the interfascial plane between the rhomboideus major muscle and ESM. The local anesthetic spread will be visualized in a fascial longitudinal pattern deep to the ESM.

Other: Ultrasound guided lumbar erectae spinae block; Other: Intrathecal Morphine injection

Group (Intrathecal morphine)

ACTIVE COMPARATOR

In the group of intrathecal morphine , a lumbar puncture will be done in the lateral position via a midline approach into the level of the vertebra which exists in the middle of the incision with complete aseptic condition using 25 gauge Quincke spinal needle to give 0.3 mg of morphine (preservative free form) suspended in 0.4 ml of normal saline .

Other: Ultrasound guided lumbar erectae spinae block; Other: Intrathecal Morphine injection

Interventions

Ultrasound guided lumbar erectae spinae block OTHER

One group by using ultrasound for making erectae spinae block

Group ( ultrasound guided erectae spinae block); Group (Intrathecal morphine)

Intrathecal Morphine injection OTHER

Injecting intrathecal morphine

Group ( ultrasound guided erectae spinae block); Group (Intrathecal morphine)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I, II patients who will be scheduled for elective lumbar surgery for one or two levels. • Age range from 18 and 70 years.

You may not qualify if:

• patient refusal.
• significant renal, hepatic and cardiovascular diseases.
• History of allergy to one of the study drugs.
• Pregnancy.
• Any contraindication to regional anesthesia such as local infection or bleeding disorders.
• Chronic opioid use, history of chronic pain and cognitive disorders.
• Lumbar spine lesion revision and dural tear.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Atef Mohamed mahmoud

Al Fayyum, 63511, Egypt

Location

Related Publications (1)

• Mahmoud AM, Ragab SG, Shawky MA, Masry DH, Botros JM. The Efficacy of Erector Spinae Plane Block Compared With Intrathecal Morphine in Postoperative Analgesia in Patients Undergoing Lumbar Spine Surgery: A Double-blind Prospective Comparative Study. Pain Physician. 2023 Mar;26(2):149-159.

  PMID: 36988361 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done via computer-generated random numbers that will be placed in separate closed envelopes and will be opened by study investigators just after induction of general anesthesia. Neither the patients, the study investigators, the attending clinicians nor the data collectors will be aware of the allocation of groups till the study ends.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The patients will be allocated in 1:1 ratio to one of the two groups: group erector spinae plane block (n=41), and group intrathecal morphine (n=41).

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: November 17, 2021
• Study Start: January 20, 2021
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)