Sacral Erector Spinae Plane Block Effect on Post-Hemorrhoidectomy Pain

NCT05965674 | Completed

• 1 other identifier: KonyaCityH Study Hemo
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Hemorrhoids are commonly observed surgical conditions affecting the anorectal area, characterized by symptoms such as pain, bleeding, and the presence of a protruding mass from the anal opening. Fear of postoperative pain is one of the most important factors for patients to avoid surgical interventions. Postoperative pain is a significant concern, with over 80% of patients encountering moderate to severe pain. The main aim is to evaluate ESPB from the sacral level would result in effective analgesia following hemorrhoidectomy. It is also aimed if sacral ESPB would reduce the use of additional analgesics after hemorrhoidectomy and increase patient satisfaction. In this prospective, randomized, controlled trial, our main objective was to examine the postoperative analgesic effects of sacral ESPB following hemorrhoidectomy.

Conditions

Postoperative Pain

Keywords

Sacral Erector Spinae Plane Block; Post-Hemorrhoidectomy Pain; Analgesic consumption

Outcome Measures

Primary Outcomes (1)

• pain intensity at rest and in motion evaluated with an NRS (0-10, 0 = no pain, 10 = worst pain) at 0, 2, 4, 6, 12, and 24h.

  The primary outcome is pain score at rest and in motion evaluated with an NRS (0-10, 0 = no pain, 10 = worst pain) at 0, 2, 4, 6, 12, and 24h.

  Perioperative period

Secondary Outcomes (1)

• The cumulative doses of tramadol, the number of patients who required rescue medication postoperatively, and QoR-15T patient recovery quality.

  Perioperative period

Study Arms (2)

The sacral ESPB group (Group S)

ACTIVE COMPARATOR

Patients in Group S underwent a procedure where a high-frequency linear ultrasound probe (Clarius, 205-2980 Virtual Way, Vancouver, BC, Canada V5M 4X3 MyLabFive; Esaote Europe BV Philipsweg 1 6227 AJ, Maastricht, the Netherlands) was positioned on the transverse plane, specifically on the fifth spinous process. The probe was then moved downwards to visualize the first and second median sacral crest. Next, the transducer was placed 3-4 cm laterally to the second medial sacral crest in order to visualize the intermediate sacral crest. In the interfascial plane, a total of 20 mL of local anesthetic solution (comprised of 10 mL bupivacaine 0.5%, 5 mL lidocaine 2%, and 5 mL normal saline) was injected between the erector spinae muscles and the intermediate sacral crest. The same procedure was performed on the contralateral side.

Procedure: Sacral Erector Spinae Plane Block

The control group (Group N)

NO INTERVENTION

It will not be performed any extra intervention, just rutin clinic protocol.

Interventions

Sacral Erector Spinae Plane Block PROCEDURE

The transducer will be placed 3-4 cm laterally to the second medial sacral crest in order to visualize the intermediate sacral crest. In the interfascial plane, a total of 20 mL of local anesthetic solution (comprised of 10 mL bupivacaine 0.5%, 5 mL lidocaine 2%, and 5 mL normal saline) will be injected between the erector spinae muscles and the intermediate sacral crest. The same procedure will be performed on the contralateral side.

The sacral ESPB group (Group S)

Eligibility Criteria

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

You may qualify if:

• being between the ages of 18 and 65,
• having an ASA status of 1-2.

You may not qualify if:

• under the age of 18, pregnant individuals,
• significant hematopoietic, cardiovascular, liver, or kidney disorders,
• patients unable to comply with medical instructions, individuals on anticoagulant therapy, and those with contraindications to regional anesthetic agents or a history of previous hemorrhoidectomy.

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Aydın Mermer

Konya, Selcuklu, 42080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 28, 2023
• Study Start: June 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 7, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

TU (1)