Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Pain

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Analgesics

All Drugs and Chemicals

press tack needle acupuncture (ACU) and routine postoperative analgesic care

press tack placebo acupressure (SHAM) and routine postoperative analgesic care

Patients in the control group will receive only routine postoperative analgesic care

On the day before surgery, patients randomized to the intervention groups will receive routine postoperative analgesic care with application of 6 bilateral press tack needles (diameter of 0.15mm and length of 0.6mm for P-6 and Shenmen, diameter of 0.20mm and length of 1.2mm for SP-6, Seirin New Pyonex, Seirin Corp., Shizuoka City, Japan).

Acupuncture

On the day before surgery, patients randomized to the intervention groups will receive routine postoperative analgesic care with application of 6 bilateral press tack placebos (knob without needle, diameter of 0.15mm and length of 0.6mm for P-6 and Shenmen, diameter of 0.20mm and length of 1.2mm for SP-6, Seirin New Pyonex, Seirin Corp., Shizuoka City, Japan).

Acupressure

Hans Heinzer, Prof.

Acupuncture has been shown in several meta-analyses and clinical studies, in different surgical settings and chronic back pain, to be a safe adjuvant option for postoperative pain treatment. In this study, the investigator hypothesize that acupuncture can decrease postoperative pain intensity and amount of given analgesics, and accelerate recovery of bowel motility, in patients after open radical prostatectomy.

The investigator will also investigate whether or not acupuncture with needle skin penetration is more efficacious than acupressure.

This study will be a randomized, controlled and partially blinded study with three arms: 1) press tack needle acupuncture (ACU) and routine postoperative analgesic care, 2) press tack placebo acupressure (SHAM) and routine postoperative analgesic care, and 3) only routine postoperative analgesic care (CONTROL).

Acupuncture With Press Tack Needles for Perioperative Pain After Open Radical Prostatectomy

A Randomized Controlled Study on Acupuncture for Perioperative Pain After Open Radical Prostatectomy

The primary outcome is to check the effects of permanent needle acupuncture at 6 acupuncture points for changing postoperative pain intensity as measured by the Numeric Rating Scale (NRS-11), calculated as area under the curve (AUC).

Cumulative use (sum in mg) of routine postoperative analgesics

Time to first defecation following surgery

fill out a questionnaire: According to the website httpp://euroqol.org/eq-5d-instruments/eq-5d-5l-about/ under the tab "User guide 5L", page 5 in a blue box, it states that EQ-5D-5L is not an abbreviation and should be used and quoted as is. The EQ-5D-5L questionnaire measures quality of life based on 5 different levels (no problems, slight problems, moderate problems, severe problems and extreme problems) to each of the following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Seirin Corporation, Shizuoka City, Japan

Martini-Klinik am UKE GmbH

Nervous System Diseases

Rare Diseases

Pain, Postoperative

Postoperative Complications

Acute Pain

Neurologic Manifestations

Acute Graft Versus Host Disease

Central Nervous System Depressants

Anesthetics

Ropivacaine

Analgesics, Opioid

Anesthetics, Local

ESPB performed with infusion of Ropivacaine 0,375% (20 ml at ech side)

ESPB performed with infusion of N/S 0,9% (20 ml at each side)

Effect of continuous ESPB performed with Ropivacaine 0,375% infusion, in patients undergoing elective laparoscopic colectomy.

Ropivacaine injection

Freideriki Sifaki, M.D., MSc

Pelagia Chloropoulou, PhD

Freideriki Sifaki, MSc

The aim of the trial is to study the efficacy of continuous bilateral Erector Spinae Plane Block (ESPB) in managing perioperative pain in patients who undergo elective laparoscopic colectomy.

Laparoscopic colectomy is a common surgery performed by general surgeons for a variety of reasons, such as colon cancer, inflammatory bowel disease, multiple precancerous colon polyps. Nowadays, due to the evolution of laraposcopic techniques, laparoscopic colectomies are performed with minimally invasive procedures. However, most patients complain for moderate to severe post-operative pain, which requires the application of multimodal analgesia recipes and the administration of large doses of opioids perioperatively, in order to be relieved. Due to the opioid crisis observed in the U.S. and in many european countries and due to the variety of adverse effects observed after the administration of opioids (respiratory depression, nausea, vomiting, delayed mobilization of gastrointestinal system and the patient), which augment not only the hospitalization time but also the hospitilization cost of the patients, anesthesiologists tend to limit their administration, especially in colectomies.

Erector Spinae Plane Block (ESPB) is an innovating trunk block, which was first described in 2016 by Forrero et. al in order to relieve neuropathic pain. Since then, it was embraced by modern anesthesia practices and is currently effectively performed for chronic pain, acute post-traumatic and acute post-operative pain, in various surgical procedures. Specifically, ESPB has been performed for the treatment of thoracic neuropathic pain, of acute post-operative pain after thoracotomy, laparoscopic cholecystectomy, total hip arthroplasty, modified radical mastectomy, emergent laparotomy and after various surgical procedures of the spine, with good results.

There are no clinical trials that study the effectiveness of continuous bilateral Erector Spinae Plane Block in laparoscopic colectomies.

This trial is a randomized, controlled, double - blind, prospective trial, predominantly aiming at evaluating the effectiveness of continuous bilateral Erector Spinae Plane Block (ESPB) in managing perioperative pain in patients who undergo elective laparoscopic colectomy.

This trial will recruit 40 patients (men and women), aged 18 to 85 years old who will undergo laparoscopic colectomy, performed by the same experienced, surgical team.

Patients will be randomized into two groups, Group B (Block Group - Ropivacaine 0,375%) and Group C (Control group - N/S 0,9%).

ESPB will be performed bilaterally, accompanied with the placement of catheters for continuous solution infusion, by the same, experienced in regional anesthesia anesthesiologist, before the induction of general anesthesia. The solutions administered during the performance of ESPB, will be prepared by an independent anesthesiology nurse. The quality of the ultrasound image and the pain intensity during the performance of ESPB, as well as the dermotomes blocked by ESPB and the complications that may arise after the performance of the block, will be recorded.

The age, sex, Body Mass Index and American Society of Anesthesiologists (ASA) classification of the participants, will be recorded. Preoperative standard laboratory tests, as well as TNF-a, Interleukine-1 and Interleukine-6 levels will be recorded.

After the induction of general anesthesia \[propofol (2,5 mg/kg), fentanyl (1 γ/kg), rocuronium (0,6 mg/kg)\], general anesthesia will be maintained with desflurane titration, guided by BIS Monitor readings. In all patients, remifentanil infusion will be titrated in order to achieve intraoperative analgesia, guided by Nociception Monitoring (NOL Monitor). In all patients Magnesium Sulphate 50 mg/kg and Pantoprazole 40 mg will be administered at the start of the surgical procedure. Paracetamol 1000 mg, Tramadol 100 mg, Droperidol 1,25 mg and Ondansetron 4 mg will be also administered to all patients 30 minutes before the end of surgery. During surgery, vital signs, BIS and NOL readings, Cardiac Output, Stroke Volume Variation, Glucose and Lactate levels will be recorded. Total fluids, desflurane and remifentanyl administration, urine output, as well as the administration of other drugs will also be recorded. At the end of surgery, Train of Four stimulation will be performed and in the presence of remaining neuromuscular blockade, sugammadex will be administered in the proper doses.

In all patients, post - operative analgesia will include administration of Paracetamol 1000 mg every 6 hours. Tramadol 50 mg will be offered as rescue analgesia, if NRS pain score of the patient is \> 4. 12, 24, 36 and 48 hours after the performance of ESPB, Ropivacaine 0,375% (patients randomized in Group B) or N/S 0,9% (patients randomized in Group C) will be infused through the ESPB catheters.

The duration of stay of the patient in Post Anesthesia Care Unit (PACU), the Aldrete Score and the vital signs the moment the patient leaves the PACU, will be recorded.

Post - operative observation of the patient will include recording of NRS pain score at rest and activity, Post-Operative Nausea and Vomiting Score, tramadol consumption, vital signs, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the end of surgery. Quality of Recovery Score of the patient will be recorded 72 hours after the end of surgery. Mobilization time of the patient and of the gastrointestinal tract, the time of removal of bladder catheter and drainages, the time of start of oral fluids and enteral nutrition, the discharge time and the total cost, will also be recorded. The satisfaction score of the patient in a scale from 1 to 6, 96 hours after the end of surgery will be recorded. Standard laboratory tests of the first, second and third post-operative days will be recorded, as well as the TNF-a, Interleukine-1 and Interleukine-6 levels the first and the fourth post-operative day.

EFFECT - EFFectiveness of ESPB (Erector Spinae Plane Block) in Laparoscopic Cοlectomies Trial

Effectiveness of Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Colectomies -A Randomized, Controlled, Double Blind, Prospective Trial

Quality of Recovery-15 \[(QoR) -15\] Questionnaire. A questionnaire which consists of 15 questions in two Parts, rated from 0 to 10 ("0" is the worst and "10" is the best answer). The worst overall score is 0 and the best overall score is 150.

Time of Mobilization of the gastrointestinal tract and of the patient

Time of start of oral fluids and enteral nutrition

Satisfaction Score of the patient regarding perioperative analgesia, using a numerical rating scale from 1 to 6, where "1" means not satisfied at all and "6" means completely satisfied.

Duration of hospital stay after surgery in days

Pain score at discharge from Post-Anesthesia Care Unit (PACU), ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score at discharge from Post-Anesthesia Care Unit (PACU), ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.

Pain score 12 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 12 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.

Pain score 24 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 24 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.

Pain score 36 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 36 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.

Pain score 48 hours post - operatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable", Post Operative Nausea and Vomiting Score 48 hours post - operatively, ranging from 0 to 2, where "0" means no PONV, "1" means nausea and "2" means vomiting.

Total intraoperative Desflurane Consumption

Total intraoperative Remifentanyl Consumption

Total cost of surgery, anesthesia and hospitalization

Comparison of TNF-a, Interleukine-1 and Interleukine-6 levels preoperatively and post - operatively (the first and fourth day after surgery)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Acupuncture With Press Tack Needles for Perioperative Pain After Open Radical Prostatectomy	NCT04172649	Prostate Cancer Perioperative P...	Acupuncture Acupressure	18 Years - 70 Years	Martini-Klinik am UKE GmbH
Acupuncture With Press Tack Needles for Perioperative Pain After Open Radical Prostatectomy	NCT04172649	Prostate Cancer Perioperative P...	Acupuncture Acupressure	18 Years - 70 Years	Martini-Klinik am UKE GmbH
EFFECT - EFFectiveness of ESPB (Erector Spinae Plane Block) in Laparoscopic Cοlectomies Trial	NCT04879004	Pain, Postopera... Acute Pain Postoperative C... Pain Ropivacaine Analgesia Regional Anesth... Analgesics Anesthesia, Loc... Colorectal Canc... Perioperative P...	Ropivacaine inj...	18 Years - 85 Years	Democritus University of Thrace
EFFECT - EFFectiveness of ESPB (Erector Spinae Plane Block) in Laparoscopic Cοlectomies Trial	NCT04879004	Pain, Postopera... Acute Pain Postoperative C... Pain Ropivacaine Analgesia Regional Anesth... Analgesics Anesthesia, Loc... Colorectal Canc... Perioperative P...	Ropivacaine inj...	18 Years - 85 Years	Democritus University of Thrace
EFFECT - EFFectiveness of ESPB (Erector Spinae Plane Block) in Laparoscopic Cοlectomies Trial	NCT04879004	Pain, Postopera... Acute Pain Postoperative C... Pain Ropivacaine Analgesia Regional Anesth... Analgesics Anesthesia, Loc... Colorectal Canc... Perioperative P...	Ropivacaine inj...	18 Years - 85 Years	Democritus University of Thrace
EFFECT - EFFectiveness of ESPB (Erector Spinae Plane Block) in Laparoscopic Cοlectomies Trial	NCT04879004	Pain, Postopera... Acute Pain Postoperative C... Pain Ropivacaine Analgesia Regional Anesth... Analgesics Anesthesia, Loc... Colorectal Canc... Perioperative P...	Ropivacaine inj...	18 Years - 85 Years	Democritus University of Thrace

Spots Global Cancer Trial Database for perioperative pain