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Ultrasound-guided Erector Spinae Block Versus Quadratus Lumborum Block for Laparotomies

Primary Purpose

Analgesia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
erector spinae plane block
Quadratus lumborum plane block
placebo
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring ESPB, QLPB, analgesia, postoperative pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18-60 years.
  • ASA I-II.
  • Both sexes.
  • Open laparotomies.

Exclusion Criteria:

  1. Patient refusal
  2. Allergy to local anesthetics
  3. BMI >40 kg/m2
  4. Bleeding diathesis or history of anticoagulant use.
  5. Psychiatric diseases.
  6. Infection of the skin at the site of needle punctures area.

Sites / Locations

  • Minia University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Erector spinae plane block (ESPB)

Quadratus lumborum plane block (QLPB)

Control group

Arm Description

20 ml of 0.25% bupivacaine will be administered to perform ESP block on each side

The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1.

patients received no regional block

Outcomes

Primary Outcome Measures

Total analgesic consumption
total fentanyl consumption as rescue analgesia

Secondary Outcome Measures

Time of first analgesic request.
first dose of rescue analgesia
dynamic Visual analogue pain score
degree of pain description on movement from (0-10 )which 0-3 is the no pain, 4-5 mild pain, 6-8 moderate pain and 9-10 severe pain
resting Visual analogue pain score
degree of pain description on rest from (0-10 )which 0-3 is the no pain, 4-5 mild pain, 6-8 moderate pain and 9-10 severe pain

Full Information

First Posted
July 3, 2021
Last Updated
November 3, 2022
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT04965194
Brief Title
Ultrasound-guided Erector Spinae Block Versus Quadratus Lumborum Block for Laparotomies
Official Title
Ultrasound-guided Erector Spinae Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparotomies: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies. This prospective randomized controlled study will be done after obtaining ethics committee's permission and written informed consent of the patients 60 adult patients aged 18-60 years scheduled for open laparotomies under general anesthesia will be included in this study. According to the used technique, the patients will be randomly allocated into 3 parallel equal groups (20 patients in each one). Group I (ES group): the patients will receive bilateral ESP block. Group II (QL group): the patients will receive bilateral QL block. Group III (control group): the patients will not receive any regional block.
Detailed Description
Postoperative pain management is one of the most important issues influencing the outcome of surgery. Postoperative pain, especially when poorly controlled, results in harmful acute effects such as adverse physiological responses and chronic effects like delayed long term recovery and chronic pain.the investigators aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies. Primary outcome: Total analgesic consumption in the first 24hrs postoperative. Secondary outcomes: Time of first analgesic request. Visual analogue pain score in the first 24hrs postoperative Incidence of any side effects. All patients will be premedicated using midazolam 0.03 mg /kg iv upon arrival to the operating room then standard monitoring which included SPO2, ECG, non-invasive blood pressure monitoring will be applied. All patients will receive the same anesthetic technique. Following anesthesia induction using 1-2 mcg/kg fentanyl, 2- 3 mg/kg propofol, and 0.5 mg/kg atracurium, the patients will be intubated and maintenance of anesthesia will be done by Isoflurane (MAC 1.2) and intermittent doses of atracurium to maintain adequate muscle relaxation. All hemodynamics will be measured before and after induction of general anesthesia and then every 5 min till end of surgery. In ES group: superficial probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T7. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic (LA), and 20 ml of 0.25% bupivacaine will be administered to perform ESP block. LA spread to both cranial and caudal directions will be seen. In QL group: A curved array transducer for the transmuscular QL (TQL) nerve block is placed in the axial plane on the patient's flank just cranial to the iliac crest. The "shamrock sign" is visualized: The transverse process of vertebra L4 is the stem, whereas the erector spinae posteriorly, QL laterally, and psoas major anteriorly represents the three leaves of the trefoil. The target for injection is the fascial plane between the QL and psoas major muscles. The needle is inserted using an in-plane technique from the posterior end of the transducer through the QL muscle. The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1. Before the end of the surgery all patients will receive 1g of paracetamol IV, at the end of the surgery reversal of neuromuscular blockade will be done by neostigmine and atropine and then the patients will be transferred to recovery room. 30 mg of ketorolac will be given to all patients every 8 hrs. Parameters will be assessed: Intraoperative: Hemodynamics after induction of anesthesia, after block and then every 15min till the end of surgery. Postoperative: Hemodynamics immediately after recovery and then 1, 2, 4, 8, 12, 16, 20and 24 hrs postoperative. VAS in the same previous intervals. Time of first analgesic request. Total analgesic requirement in the first 24 hrs. postoperative. Incidence of side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
Keywords
ESPB, QLPB, analgesia, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector spinae plane block (ESPB)
Arm Type
Experimental
Arm Description
20 ml of 0.25% bupivacaine will be administered to perform ESP block on each side
Arm Title
Quadratus lumborum plane block (QLPB)
Arm Type
Experimental
Arm Description
The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
patients received no regional block
Intervention Type
Procedure
Intervention Name(s)
erector spinae plane block
Intervention Description
Superficial probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T8. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic (LA), and 20 ml of 0.25% bupivacaine will be administered to perform ESP block. LA spread to both cranial and caudal directions will be seen.
Intervention Type
Procedure
Intervention Name(s)
Quadratus lumborum plane block
Intervention Description
A curved array transducer for the transmuscular QL (TQL) nerve block is placed in the axial plane on the patient's flank just cranial to the iliac crest. The "shamrock sign" is visualized: The transverse process of vertebra L4 is the stem, whereas the erector spinae posteriorly, QL laterally, and psoas major anteriorly represents the three leaves of the trefoil. The target for injection is the fascial plane between the QL and psoas major muscles. The needle is inserted using an in-plane technique from the posterior end of the transducer through the QL muscle. The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
patients received no regional block
Primary Outcome Measure Information:
Title
Total analgesic consumption
Description
total fentanyl consumption as rescue analgesia
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Time of first analgesic request.
Description
first dose of rescue analgesia
Time Frame
24 hours
Title
dynamic Visual analogue pain score
Description
degree of pain description on movement from (0-10 )which 0-3 is the no pain, 4-5 mild pain, 6-8 moderate pain and 9-10 severe pain
Time Frame
24 hours
Title
resting Visual analogue pain score
Description
degree of pain description on rest from (0-10 )which 0-3 is the no pain, 4-5 mild pain, 6-8 moderate pain and 9-10 severe pain
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-60 years. ASA I-II. Both sexes. Open laparotomies. Exclusion Criteria: Patient refusal Allergy to local anesthetics BMI >40 kg/m2 Bleeding diathesis or history of anticoagulant use. Psychiatric diseases. Infection of the skin at the site of needle punctures area.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shadwa R Mohamed, MD
Organizational Affiliation
Mina university hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed H Mohamed
Organizational Affiliation
Minia Universiry hospital
Official's Role
Study Director
Facility Information:
Facility Name
Minia University Hospital
City
Minya
State/Province
Minia
ZIP/Postal Code
61111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Ultrasound-guided Erector Spinae Block Versus Quadratus Lumborum Block for Laparotomies

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