NCT05574283

Brief Summary

Colorectal cancers are one of the leading causes of cancer-related mortality, and the incidence is increasing day by day. For this reason, colorectal cancer surgery and postoperative analgesia have gained more importance in recent years.Although laparoscopic surgery is less invasive, it can still generate moderate to severe acute postoperative pain.For a long time, opioids have played a major role in postoperative analgesia, but heavy use of these drugs will cause adverse reactions such as nausea, vomiting and enteroparalysis, which is not conducive to rapid recovery after surgery Therefore, it is critical to developing a more effective regional analgesic technique for patients undergoing abdominal surgery . Erector spinae plane block (ESPB) is a novel interfascial plane block technique that was firstly described in 2016. It involves injecting local anesthetic into the plane between the deep fascia of the erector spinae muscle and the vertebral transverse process under ultrasound guidance to relieve pain in the thoracoabdominal region .The quadratus lumborum block (QLB) is a new posterior abdominal trunk block which produces analgesic effects through local anesthetic that covers thoracolumbar fascia and thoracic paravertebral space. Based on the injection position and approach, there are 3 QLB techniques: lateral approach, posterior approach and anterior approach. The anterior transmuscular quadratus lumborum block (TQLB) is a truncal block (ventral rami of T7- L2) that produces its analgesic effect by blocking the thoracic sympathetic trunk, the ventral rami of lower spinal nerves, the sympathetic fibers and mechanoreceptors within the thoracolumbar fascia, and the celiac ganglion by spread via the splanchnic nerves .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 4, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2023

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

October 4, 2022

Last Update Submit

October 6, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total dose of rescue analgesia that was consumed in the first 24 hours postoperatively.

    Total dose of rescue analgesia (nalbuphine) , that was consumed in the first 24 hours postoperatively,if patient visual analogue score more than or equal 3.

    First 24 hours postoperatively. Starting immediately after surgery up to 24 hours.

Secondary Outcomes (1)

  • 1st time to rescue analgesic (min).

    First 24 hours postoperatively. Starting from the end of the surgery up to 24 hours..

Study Arms (2)

ESPB group

EXPERIMENTAL

ESPB group: 30 patients will receive bilateral ultrasound-guided erector spinae plane block using 20 ml of bupivacaine 0.25% with 4 mg dexamethasone for each side.

Procedure: Erector spinae plane block and transmuscular quadratus lumborum block

TQLB group

EXPERIMENTAL

TQLB group: 30 patient will receive bilateral ultrasound-guided transmuscular quadratus lumborum block using 20 ml of bupivacaine 0.25% with 4 mg dexamethasone for each side.

Procedure: Erector spinae plane block and transmuscular quadratus lumborum block

Interventions

All blocks were performed after securing the airway before the start of surgery. ESPB group will receive bilateral ultrasound-guided erector spinae plane block using 20 ml of bupivacaine 0.25% with 4 mg dexamethasone for each side. TQLB group will receive bilateral ultrasound-guided transmuscular quadratus lumborum block using 20 ml of bupivacaine 0.25% with 4 mg dexamethasone for each side

ESPB groupTQLB group

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 35 and 75 years.
  • patient scheduled for laparoscopic resection of colorectal cancer.
  • American Society of Anesthesiologists classification of physical status \< IV.
  • body's mass index (BMI) ≤ 35 kg/m2.

You may not qualify if:

  • Refusal of the patient.
  • known hypersensitivity to any study medication.
  • Chronic opioid use or chronic pain patient.
  • Liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7).
  • Renal insufficiency (defined as a glomerular filtration rate \< 44 ml/min).
  • MOrbid obesity (defined as a BMI \> 35 kg/m2).
  • Obstructive sleep apnea syndrom.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benisuef university

Banī Suwayf, 11311, Egypt

RECRUITING

Related Publications (1)

  • Mahmoud Fakhry D, ElMoutaz Mahmoud H, Yehia Kassim D, NegmEldeen AbdElAzeem H. Erector Spinae Plane Block versus Quadratus Lumborum Block for Postoperative Analgesia after Laparoscopic Resection of Colorectal Cancer: A Prospective Randomized Study. Anesthesiol Res Pract. 2024 Mar 18;2024:6200915. doi: 10.1155/2024/6200915. eCollection 2024.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • hebatullah Negmeldeen, lecturer

    Beni-Suef University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HEBATULLAH Negmeldeen, lecturer

CONTACT

Dina Kasem, A.P

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaesthesia

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 10, 2022

Study Start

October 4, 2022

Primary Completion

October 4, 2023

Study Completion

October 4, 2023

Last Updated

October 10, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations