Erector Spinae Plane Block as Analgesia in Patients for Colectomy

May 7, 2025 updated by: Abdelrhman Alshawadfy, Suez Canal University

Erector Spinae Plane Block as Analgesia in Patients for Colectomy: A Randomized Controlled Study

Management of postoperative pain relief is largely inadequate. Despite the recent advances in pain management, postoperative pain incidence has not decreased; most patients still experience severe pain after major surgery. Poorly or inadequately controlled pain was reported to be linked to prolonged hospitalization, decreased patient satisfaction, the risk of readmission, and a higher incidence of postoperative complications.

Study Overview

Status

Completed

Conditions

Detailed Description

In major abdominal surgeries, the gold standard for postoperative analgesia is thoracic epidural analgesia. Nevertheless, there are many concerns regarding its side effects, including motor blockade and hypotension. Moreover, many researchers interrogated its role as it may increase the risk of serious problems such as epidural hematoma and abscess. As an alternative, some surgeons proposed the transversus abdominis plane (TAP); however, a recent meta-analysis established that TAP block was of minimal effect.

The erector spinae plane block (ESPB) is a fairly original paraspinal plane block that was first designated for thoracic analgesia. Recently, some reports showed that it could offer effective and widespread somatic and visceral abdominal analgesia. Bilateral continuous ESP blockade represents a respected alternative to thoracic epidural analgesia. The local injection under the erector spinae muscle is carried out in this technique, which is estimated to spread a paravertebral of three vertebral levels cranially and four levels caudally. It was designated that the injected local anesthesia passes across the costotransverse foramina and blocks the ventral and dorsal rami of spinal nerves, causing a sensory blockade over the anterolateral thorax. The dermatomes enclosed by ESPB depend on the site of entry, the volume, and the concentration of the local anesthetic used. This RCT aimed to assess the analgesic effectiveness of US-guided bilateral erector spinae plane block in patients undergoing elective colectomy.

This randomized controlled trial was designed to assess the analgesic effectiveness of bilateral US-guided erector spinae plane blocks (ESPB) in patients undergoing elective colectomy surgery.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ismailia, Egypt
        • Faculty of Medicine, Suez Canal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients of colorectal carcinoma scheduled for elective colectomy

Exclusion Criteria:

  • Patients with a body mass index (BMI) of 35 kg/m2 or above
  • patients with a history of hepatic or renal diseases
  • patients with second- or third-degree heart blocks
  • patients with coagulopathies
  • patients with history of hypersensitivity to local anesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ESPB
ESPB using local anaesthetic 20 ml 0.25% bupivacaine on each side
ESPB using local anesthetic 20 ml 0.25% bupivacaine on each side
Placebo Comparator: Saline
ESPB using normal saline 20 ml on each side
ESPB using normal saline 20 ml 0.25% bupivacaine on each side

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphine consumption
Time Frame: From the time of end of surgery till the pass of the first 24 hours postoperatively
postoperative total morphine consumption over 24 hours
From the time of end of surgery till the pass of the first 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

December 15, 2024

Study Registration Dates

First Submitted

April 26, 2025

First Submitted That Met QC Criteria

April 26, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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