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NCT Number: NCT06957574

Erector Spinae Plane Block as Analgesia in Patients for Colectomy

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.

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Key information

Conditions

Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of medicine, Suez Canal University

Ismailia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bubpivacaine

Drug

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

Normal saline (placebo)

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 4, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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