Erector Spinae Plane Block as Analgesia in Patients for Colectomy

NCT ID: NCT06957574

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2024-12-15

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.

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.

Conditions

Colo-rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ESPB

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

Group Type: ACTIVE_COMPARATOR

Bubpivacaine

Intervention Type: DRUG

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

Saline

ESPB using normal saline 20 ml on each side

Group Type: PLACEBO_COMPARATOR

Normal Saline (Placebo)

Intervention Type: DRUG

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

Interventions

Bubpivacaine

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

Intervention Type: DRUG

Normal Saline (Placebo)

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrhman Alshawadfy

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

faculty of medicine, Suez Canal University

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

ESPB

Identifier Type: -

Identifier Source: org_study_id