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Postoperative Pain ManagementNCT04434339

Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia of Adult Patients Undergoing Ovarian Cancer Surgery

A study testing erector spinae block and transversus abdominis block in people with Postoperative Pain Management, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Postoperative pain is one of the greatest patient concerns following any surgery. Although an increased emphasis has been placed on pain management, approximately 80% of surgical patients report postoperative pain with 86% of patients rating their pain as moderate, severe, or extreme. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postoperative Pain Management
What is being tested?
erector spinae block and transversus abdominis block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteEgypt
Study dates
15 Jul 2020to 2 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • female Patients undergoing ovarian cancer surgery under general anesthesia with ASA I-II and Age ≥ 18 and ≤ 65 Years

Who cannot join

  • Patient refusal.
  • uncooperative patients
  • Cardiovascular disease in the form of Uncontrolled hypertension, IHD, AF, cardiomyopathy with EF <50%
  • Cerebrovascular insufficiency in the form of TIAs, REND, stroke, cerebral hemorrhage, brain tumour, epilepsy
  • Coagulation defects with INR>1.5 platelets count< 80000
  • hepatic insufficiency with ALT and AST > twice normal, total bilirubin >1.5 , PC < 80%.
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  • Hypersensitivity to the study drugs.
  • Pregnant patients
  • patients receiving vasoactive drugs or beta blockers

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • anesthesia department at Cairo University

    Cairo, Manial, 11512

Other trials in Egypt

About this study

Official title: A Comparison Between Ultrasound-guided Erector Spinae Plane Block and Transversus Abdominis Plane Block for Postoperative Analgesia of Adult Patients Undergoing Ovarian Cancer Surgery Under General Anesthesia: Randomized, Controlled Study.

Postoperative pain is one of the greatest patient concerns following any surgery. Although an increased emphasis has been placed on pain management, approximately 80% of surgical patients report postoperative pain with 86% of patients rating their pain as moderate, severe, or extreme.

In recent years, the increasing adoption of ultrasound-guided regional anesthesia for acute pain management parallels the rapid rise in the availability of ultrasound machines, facilitating description of a number of important fascial plane blocks blocking the dorsal, lateral and anterior cutaneous nerves of the thorax and abdomen. These new descriptions in blocks are supposed to be an advance in regional anesthesia due to its simplicity and lack of complications. These include the transversus abdominis plane block, rectus sheath block, quadratus lumborum block, pectoralis nerve block, serratus plane block, retrolaminar block, and now the Erector spinae block.

Read more

Although ESP and TAB blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing ovarian cancer surgery under general anesthesia thus in this randomized controlled study we are aiming to fill this gap in the literature.

Hypothesis Analgesia provided by the erector spine plane block is superior to that of transversus abdominis block in patients undergoing ovarian cancer surgery under general anesthesia.

Read the detailed description

Introduction:

Postoperative pain is one of the greatest patient concerns following any surgery. Although an increased emphasis has been placed on pain management, approximately 80% of surgical patients report postoperative pain with 86% of patients rating their pain as moderate, severe, or extreme.

In recent years, the increasing adoption of ultrasound-guided regional anesthesia for acute pain management parallels the rapid rise in the availability of ultrasound machines, facilitating description of a number of important fascial plane blocks blocking the dorsal, lateral and anterior cutaneous nerves of the thorax and abdomen. These new descriptions in blocks are supposed to be an advance in regional anesthesia due to its simplicity and lack of complications. These include the transversus abdominis plane block, rectus sheath block, quadratus lumborum block, pectoralis nerve block, serratus plane block, retrolaminar block, and now the Erector spinae block.

The TAP is a potential anatomical space that lies between transversus abdominis and internal oblique muscles, where local anesthetic can be deposited, creating a non-dermatomal "field block.".This block can be placed before or during a surgery either by ultrasound guidance or by landmarking through the triangle of Petit (inferior lumbar triangle). Blocks can be placed either intra-abdominally prior to abdominal fascial closure or by transdermal injection. Transversus abdominis plane (TAP) blocks can provide reliable relief of somatic incisional pain. However, the lack of reliable visceral pain relief with TAP blocks may necessitate additional modes of analgesia.

Previous studies have investigated the efficacy of TAP blocks in benign gynecology, general surgery,and non-ovarian gynecologic oncology.These studies have had mixed outcomes, but a recent meta-analysis has demonstrated an overall reduction in pain and opioid usage associated with TAP blocks in laparotomy.

Since its first description by Forero et al. there have been many articles and case reports including an increasingly number of indications for the ESP block: chronic and acute pain treatment , rib fractures management in the emergency setting, treatment of abdominal surgical pain , hip arthroplasty , analgesic management in breast surgery,or in spinal surgery.

The ESP block targets the erector spinae plane, which lies between the anterior surface of the cephalon-caudal oriented erector spinae muscles (that arise from and insert into various bony components of the vertebral column, for example, from spinous process to spinous process, rib to rib, and transverse process to transverse process and the posterior surface of the spinal transverse processes. LA is deposited in the fascial plane deep to the erector spinae muscle and superficial to the tips of the transverse processes, from where it diffuses to the dorsal and ventral rami of spinal nerves, achieving an extensive multi-dermatomal sensory block of the posterior, lateral, and anterior thoracic wall .

ESP block could result in both visceral and somatic abdominal analgesia if the injection were performed at a lower thoracic level.as the local anesthetic penetrates anteriorly through the intertransverse connective tissue and enters the thoracic paravertebral space where it can potentially block not only the ventral and dorsal rami of spinal nerves but also the rami communicants that transmit sympathetic fibers.

For 2019 about 22,530 women will receive a new diagnosis of ovarian cancer and about 13,980 women will die from ovarian cancer as for The American Cancer Society estimation for ovarian cancer in the United States. oncologic ovarian cancer surgeries performed by general anesthesia (GA),cannot provide adequate postoperative pain control as cytoreductive and staging procedures often involve considerable visceral disruption and incisions above the umbilicus have accessory innervation. and the routine use of parenteral opioids aggravates postoperative sedation, nausea, emesis, impaired oxygenation and depressed ventilation.

Although ESP and TAB blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing ovarian cancer surgery under general anesthesia thus in this randomized controlled study we are aiming to fill this gap in the literature.

Aim of the work Aims to evaluate the analgesic effects of combined general with ultrasound-guided erector spinae block versus that of combined general with transversus abdominis block in patients undergoing major ovarian cancer surgery 1. Inclusion criteria female Patients undergoing ovarian cancer surgery under general anesthesia with ASA I-II and Age ≥ 18 and ≤ 65 Years 2. Exclusion criteria

  • Patient refusal.
  • uncooperative patients
  • Cardiovascular disease in the form of Uncontrolled hypertension, IHD, AF, cardiomyopathy with EF <50%
  • Cerebrovascular insufficiency in the form of TIAs, REND, stroke, cerebral hemorrhage, brain tumour, epilepsy
  • Coagulation defects with INR>1.5 platelets count< 80000
  • hepatic insufficiency with ALT and AST > twice normal, total bilirubin >1.5 , PC < 80%.
  • Hypersensitivity to the study drugs.
  • Pregnant patients
  • patients receiving vasoactive drugs or beta blockers V. Study Procedures
  1. Randomization (in RCT only) Computer generated sequence will be used for randomization.
  2. Study Protocol After approval of the Research Ethics Committee and written informed consent from all patients, A randomized, prospective, comparative, single blinded as the anesthesiologist who will collect data will be blinded for which block was given study to compare between ultrasound-guided erector spinae plane block and transversus abdominis plane block for postoperative analgesia of adult patients undergoing ovarian cancer surgery under general anesthesia with lower midline incision approach will be conducted on A total of 45 Patients that will be randomly allocated by using computer generated random numbers into Group1: (n=15) "ESP block group" ,Patients received preoperative US guided ESP block on BOTH sides to be operated upon 30 minutes before being transferred to the OR, Group 2: (n=15) "TAB group" ,Patients received bilateral lower TAB 30 min before being transferred to the OR and Group 3: (n=15)"the control group", Patients will not receive any block.

The day before surgery, all patients will be instructed to fast for 6-8 hours. On the day of the operation, the patient will arrive to the preparation room 1 hour before operation, to allow time for the block procedure and a minimum of 30 minutes to pass after the block before induction of general anesthesia, an 18 G cannula insertion, a start of IV fluid drip, and premedication with 0.02-0.03 mg/kg intravenous midazolam will be done. All basic monitoring will be applied (ECG/HR/SpO2/NIBP), and baseline values for HR, SPO2, SBP, DBP and MAP will be documented then every 5 minutes till the patient reaches the operating room.

In group 1 a mark will be applied on the required level (T10) identified as 3rd spinous process caudal to that of T7 which located in the middle of a line passing between the lower tips of the scapulae, the midline (spinous processes) and the injection points 3 cm on either sides from midline. While the patient is in a sitting position with support from a member of staff, Preparation of the field with iodine will be made. The ultrasound transducer is placed in a longitudinal parasagittal orientation using the HFL38X linear multi-frequency 6-13 MHz probe of SonoSite M-Turbo of portable ultrasound system anatomical landmarks will be identified including the transverse process at T10 level and the layers of muscles from posterior to anterior: trapezius-erector spinae. After subcutaneous lidocaine 2% injection a 22-G spinal needle will be inserted under ultrasound guidance in plane, aiming towards the transverse process. After a Gentle contact with the transverse process, a volume of 20 ml for each side with 0.25% bupivacaine will be injected in increments with careful repetitive aspiration to avoid intravascular injection targeting to cover dermatomal levels from T8-T12 as minimum.

In group 2 while the patient is lying supine, the probe will be placed perpendicular to the mid-axillary line between the iliac crest and subcostal margin, the 3 abdominal muscle layers were identified, and the transversus abdominis plane was located between the internal oblique and transversus abdominis muscle. Next, 20 mL of 0.25% bupivacaine will be injected in increments with careful repetitive aspiration to avoid intravascular injection, and drug spread in the plane will be observed. The same procedure will be repeated on the other side of the abdomen.

Then the patient will be transferred to the OR. All basic monitoring will be applied (ECG/HR/SpO2/NIBP) while monitoring of end-tidal CO2 will be initiated after induction of anesthesia and values will be recorded for HR, SPO2 ,SBP,DBP ,MAP and ETCO2 every 5 minutes till the end of the surgery then for 30 minutes from time of reaching PACU.

General anesthesia will be induced with 2 mg/kg propofol, 1μg/kg fentanyl and 0.5 mg/kg atracurium to facilitate endotracheal intubation. After intubation the lungs will be mechanically ventilated to maintain the ETCO2 35-40 mmHg. Anesthesia will be maintained with isoflurane keeping the ET concentration of isoflurane 1-2% to maintain the BIS value 40-60. Atracurium besylate top-up doses 0.1mg/kg will be given based on the response to train of four ulnar nerve stimulation. Additional fentanyl dose of 0.5 µg/kg IV for maximum of 3 µg/kg will be given if HR and /or BP increased more than 20% from baseline in response to surgical stimulation and the total dose of fentanyl will be recorded.

The patient's pain will be monitored and documented using the Numerical Rating Score (NRS) for pain at times 0,30 minutes, 1, 2, 4, 6, 8, 10, 12, 18 and 24 hours.(28)The "zero" point of time will be the moment the patient recovered from general anesthesia. Time to first analgesic requirement will be recorded which is the time from the "zero" point till the NRS is 4 or more.

1 g paracetamol IV will be given every 6 hours regardless the NRS value while rescue medication in the form of 50 mg tramadol IV will be given on demand when NRS score is 4 or more with maximum dose of 1 mg /kg every 6 hours and the total consumption of tramadol will be recorded.

Complications in the form of local anesthetic systemic toxicity, failed block, injury to surrounding structures (peritoneum, vessels, dura ,pleura inform of pneumothorax) will be documented

Being tested
erector spinae block, transversus abdominis block
Keywords
erector spinae, block, pain, transversus, abdominis
Medical subject headings
Bites and Stings, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erector spinae blockProcedure or surgery

    Also called erector spinae plane block

    A volume of 20 ml for each side of erector spinae plane with 0.25% plain bupivacaine

  • transversus abdominis blockProcedure or surgery

    Also called transversus abdominis plane block

    A volume of 20 ml for each side of transversus abdominis plane with 0.25% plain bupivacaine

Study groups in NCT04434339
Study groupRoleWhat they receive
group 1Experimental"ESP block group" ,Patients received preoperative US guided ESP block on BOTH sides to be operated upon 30 minutes before being transferred to the OR
Receives: Procedure: erector spinae block
group 2Experimental"TAB group" ,Patients received bilateral lower TAB 30 min before being transferred to the OR
Receives: Procedure: transversus abdominis block
group 3No intervention"the control group", Patients will not receive any block.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative tramadol consumption

    postoperative tramadol consumption in mg

    Measured: within 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start15 Jul 2020
  3. Primary completion30 Oct 2020
  4. Study completion2 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04434339
Sponsor's protocol ID
MS-104-2020
Status last verified
Dec 2020
First submitted
12 Jun 2020
Last updated
16 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: not for sharing

Publications

  • 25. .Jiří M.,et al. Postoperative Pain Management. Third updated edition.Mladá fronta a. s., Mezi Vodami 2017.1952/9 26. Tulgar S. et tal Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective,randomized, controlled clinical trial. Journal of Clinical Anesthesia .2018; (49):101-106 27. Canakci, E.et al.The Analgesic Efficacy of Transverse Abdominis Plane Block versus Epidural Block after Caesarean Delivery: Which One Is Effective? TAP Block? Epidural Block?." Pain research & management. 2018. 3562701. 28. Rodriguez CS. Pain measurement in the elderly: a review. Pain Manag Nurs 2001;(2):38-46 29. Altıparmak. B.,et tal. Ultrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia of adult patients undergoing laparoscopic cholecystectomy: Randomized, controlled trial Journal of Clinical Anesthesia. 2019;(57):31-36

Questions about this trial

What is this clinical trial studying?

A study testing erector spinae block and transversus abdominis block in people with Postoperative Pain Management, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative tramadol consumption (time frame: within 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04434339, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.

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