Erector Spinae Plane Block as Analgesia in Patients for Colectomy

NCT06957574 | Completed

• 1 other identifier: ESPB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colo-rectal Cancer

Keywords

erector spinae plane; colectomy

Outcome Measures

Primary Outcomes (1)

• morphine consumption

  postoperative total morphine consumption over 24 hours

  From the time of end of surgery till the pass of the first 24 hours postoperatively

Study Arms (2)

ESPB

ACTIVE COMPARATOR

ESPB using local anaesthetic 20 ml 0.25% bupivacaine on each side

Drug: Bubpivacaine

Saline

PLACEBO COMPARATOR

ESPB using normal saline 20 ml on each side

Drug: Normal Saline (Placebo)

Interventions

Bubpivacaine DRUG

ESPB using local anesthetic 20 ml 0.25% bupivacaine on each side

ESPB

Normal Saline (Placebo) DRUG

ESPB using normal saline 20 ml 0.25% bupivacaine on each side

Saline

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients of colorectal carcinoma scheduled for elective colectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

faculty of medicine, Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

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: Assistant professor

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 4, 2025
• Study Start: August 1, 2021
• Primary Completion: November 30, 2024
• Study Completion: December 15, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)