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Sacral Erector Spinae Plane Block Effect on Post-Hemorrhoidectomy Pain

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sacral Erector Spinae Plane Block
Sponsored by
Konya City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Sacral Erector Spinae Plane Block, Post-Hemorrhoidectomy Pain, Analgesic consumption

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aydın Mermer

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

The sacral ESPB group (Group S)

The control group (Group N)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 4, 2023
Last Updated
July 20, 2023
Sponsor
Konya City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05965674
Brief Title
Sacral Erector Spinae Plane Block Effect on Post-Hemorrhoidectomy Pain
Official Title
The Effect of Sacral Erector Spinae Plane Block on Post-Hemorrhoidectomy Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Sacral Erector Spinae Plane Block, Post-Hemorrhoidectomy Pain, Analgesic consumption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The sacral ESPB group (Group S)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
The control group (Group N)
Arm Type
No Intervention
Arm Description
It will not be performed any extra intervention, just rutin clinic protocol.
Intervention Type
Procedure
Intervention Name(s)
Sacral Erector Spinae Plane Block
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Perioperative period
Secondary Outcome Measure Information:
Title
The cumulative doses of tramadol, the number of patients who required rescue medication postoperatively, and QoR-15T patient recovery quality.
Description
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.
Time Frame
Perioperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Aydın Mermer
City
Konya
State/Province
Selcuklu
ZIP/Postal Code
42080
Country
Turkey

12. IPD Sharing Statement

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Sacral Erector Spinae Plane Block Effect on Post-Hemorrhoidectomy Pain

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