Sacral Erector Spinae Plane Block Effect on Post-Hemorrhoidectomy Pain

Postoperative Pain Clinical Trial

Official title:

The Effect of Sacral Erector Spinae Plane Block on Post-Hemorrhoidectomy Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05965674
• Other study ID #: KonyaCityH Study Hemo
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: July 7, 2023

Study information

• Verified date: July 2023
• Source: Konya City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. This heightened pain level contributes to an elevated risk of complications including atelectasis, thromboembolism, myocardial ischemia, cardiac arrhythmia, electrolyte imbalance, urinary retention, and ileus. The two main unresolved issues following surgery are postoperative pain and urinary retention. In addition to improving patient satisfaction, pain management will decrease urinary retention and constipation, especially in the first 24 hours following surgery. According to earlier research, even with analgesic therapy, 20% to 40% of patients who underwent hemorrhoidectomy would experience severe postoperative pain. Commonly used pain relievers like nonsteroidal anti-inflammatory drugs, paracetamol, and opioids often come with adverse effects such as dizziness, nausea, vomiting, and constipation and can even lead to tolerance. These side effects could prevent a full recovery and result in a poor prognosis. Bilateral pudendal nerve blocks are said to significantly reduce postoperative pain, but they are technically difficult and require specific positioning. Furthermore, the administration of pudendal nerve block carries the risk of potential complications, including hematoma formation, sciatic nerve injury, and accidental rectal puncture. Therefore, an alternative analgesic method with minimal adverse effects would be beneficial.

The erector spinae plane block (ESPB) was initially introduced as an interfascial plane block performed at the upper thoracic levels with the purpose of alleviating neuropathic pain. Subsequently, its application expanded to encompass a range of thoracic interventions, including mastectomy, video-assisted thoracoscopy (VATS), and cardiac surgery, while also being utilized at lumbar levels for procedures such as abdominal surgery, prostatectomy, lumbar spine surgery, total hip arthroplasty, and proximal femur surgery. A newly introduced method called the sacral Erector Spinae Plane Block (ESPB) has been recently documented in scientific literature. Case studies have demonstrated its effectiveness in various surgical procedures. Specifically, it has shown promise in managing radicular pain at the L5-S1 level after sex reassignment surgery and hypospadias surgery, as well as providing analgesia for the posterior branches of the sacral nerves during pilonidal sinus surgery.

The main hypothesis is that performing ESPB from the sacral level would result in effective analgesia following hemorrhoidectomy. It is also hypothesized that sacral ESPB would reduce the use of additional analgesics after hemorrhoidectomy and increase patient satisfaction. In this prospective, randomized, controlled trial, the main objective is to examine the postoperative analgesic effects of sacral ESPB following hemorrhoidectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 7, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• being between the ages of 18 and 65,

• having an ASA status of 1-2.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Sacral Erector Spinae Plane Block
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.

Locations

Country	Name	City	State
Turkey	Aydin Mermer	Konya	Selcuklu

Sponsors (1)

Lead Sponsor	Collaborator
Konya City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The cumulative doses of tramadol, the number of patients who required rescue medication postoperatively, and QoR-15T patient recovery quality.	The secondary outcome measures are the cumulative doses of tramadol, the number of patients who required rescue medication postoperatively, and QoR-15T patient recovery quality.	Perioperative period