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Postoperative PainNCT04016688

Bilateral Erector Spinae Plane Block After Elective Cesarean Section

A study testing ESPB and TAP block in people with Postoperative Pain, run by Fayoum University at 3 sites 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

The aim of work is to assess and compare the analgesic efficacy of bilateral erector spinae plane block with that of bilateral transversus abdominis plane block after elective cesarean section. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postoperative Pain
What is being tested?
ESPB and TAP block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesEgypt
Study dates
8 Jul 2019to 1 Jan 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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • aged 18 - 40 years
  • American Society of Anesthesiologists physical status ІІ, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation.

Who cannot join

  • Patient refusal.
  • Contraindications to regional anesthesia.
  • Known allergy to the study drugs.
  • Severe cardiovascular, renal or hepatic diseases.
  • Bleeding disorders.
  • Local infection.

Trial locations and contacts

3 sites in 1 country.

Egypt3 sites
  • Faculty of Medicine

    Al Fayyum, 63511

  • Mohamed Hamed

    Al Fayyum, 63511

  • Mohamed

    Al Fayyum, 65345

Other trials in Egypt

About this study

Official title: Comparative Study Between the Analgesic Effect of Erector Spinae Plane Block and Transversus Abdominis Plane Block After Elective Cesarean Section

The aim of work is to assess and compare the analgesic efficacy of bilateral erector spinae plane block with that of bilateral transversus abdominis plane block after elective cesarean section.

Read the detailed description

Inclusion criteria:

  • Parturients aged 18 - 40 years with American Society of Anesthesiologists physical status І or ІІ, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation.

Exclusion criteria:

  • Patient refusal.
  • Contraindications to regional anesthesia.
  • Known allergy to the study drugs.
  • Severe cardiovascular, renal or hepatic diseases.
  • Bleeding disorders.
  • Local infection.

Participants will be randomly divided into two groups:

Group A will receive bilateral Erector spinae plane block. (n=30) Group B will receive bilateral Transversus abdominis plane block. (n=30) Simple randomization will be performed by computer-generated random numbers that will be placed in separate opaque envelopes that will be opened by responsible anesthesiologist just before the intrathecal block.

Routine preoperative investigations including electrocardiogram (ECG), complete blood picture, renal function tests, liver function tests, and coagulation profile will be done. All parturients will fast for 8 h preoperatively. IV access will be obtained (one peripheral venous cannula 18G) and standard monitoring including pulse oximetry, ECG and noninvasive blood pressure will be placed for measurement of the hemodynamic variability.

Ten ml.kg-1 of Ringer lactate solution will be infused over 15 minutes as a preload. The parturient will be asked to turn into sitting position where the skin on the back will be sterilized and spinal anesthesia will be performed via a midline approach into the L4-5 interspaces using a 25 gauge Quincke spinal needle after giving 3 ml of lidocaine 2% as a subcutaneous infiltration. After confirming free CSF flow through the needle, a 10mg of hyperbaric bupivacaine 0.5 % will be slowly injected for both groups.

The parturient will be placed in the supine position with 15° left tilt, and an oxygen mask will be applied at 2 L.min-1. The surgical procedure will start after sufficient anesthesia level is obtained, with continuous hemodynamics monitoring and recording.

After delivery of the fetus, 10 units of oxytocin will be given by IV infusion. By the end of the surgery, patients in group (A) received bilateral ESP block. First in the supine position, sham TAP block was done then the patient was turned into the lateral position to receive ESP block and after

proper skin sterilization then the vertebrae were counted from cephalad to caudal direction until T9 spinous process was reached as the first palpable spinous process is C7 and at this level a linear ultrasound (US) transducer (Phillips Saronno Italy) was placed vertically 3cm lateral to the midline to visualize the back muscles superior to the transverse process. -A 22-G short bevel needle (spinocan, B.Braun, melsungen AG, Germany) was inserted in cranial-caudal direction until it make contact with the transverse process. Confirmation of the correct position of the tip of the needle was by injection of 1 ml saline causing hydrodisscetion between the erector spinae muscle and the transverse process. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine was injected. The same procedure was done on the other side of the back. -Patients in group (B) received bilateral TAP block. First in the supine position a linear ultrasound (US) transducer (Phillips Saronno Italy) was placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis. -A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) was introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine was injected causing an elliptical separation of the two muscles. The same procedure was done on the other side. Then the patient was placed in the lateral position to do sham ESP block.

The patients will be instructed to notify us if they have experienced any signs of systemic toxicity as circumoral or tongue numbness, dizziness, visual and auditory disturbances as difficulty focusing and tinnitus.

Spinal level will be assessed and recorded before both blocks in all patients, then they will be transferred to postoperative anesthesia care unit (PACU) with standard monitoring.

After surgery the patient will receive paracetamol 1gm IV infusion/8 hours, ketorolac 30 mg IV/12hours as a multimodal analgesia for postoperative pain.

Postoperative pain will be assessed by Visual analog scale (VAS) for pain (ranging from 0 to 10, where 0 no pain and 10 the worst possible pain) at time intervals at 0 hour, 4hours, 8 hours, 12hours and 24 hours. Postoperative mean arterial blood pressure and heart rate will be assessed and recorded.

Time for the first request to analgesia and total analgesic consumption will be recorded in the first 24 hours after surgery. Any complications as nausea and vomiting will be recorded.

Sensory block by a pin prick test will be assessed (0: normal sensation, 1: decreased pain sensation, 2: loss of pain sensation). The duration of the sensory block which is the time interval between performance of the block and complete resolution of anesthesia will be assessed and recorded every 2 hours.

Patient satisfaction with analgesia will be assessed as (0: poor, 1: good, 2: excellent).

Being tested
ESPB and TAP block
Medical subject headings
Pain, Postoperative

What participants receive

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

  • ESPB and TAP blockProcedure or surgery

    bilateral TAP block: while the patient in the supine position, a linear ultrasound (US) transducer (Phillips Saronno Italy) is placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis.

    A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) is introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.5 % bupivacaine is injected causing an elliptical separation of the two muscles. The same procedure is done on the other side.

Study groups in NCT04016688
Study groupRoleWhat they receive
ES Erector Spinae Plane BlockActive comparatorbilateral ESP block at the level of T9 by a linear ultrasound (US) transducer (Phillips Saronno Italy) placed vertically 3cm lateral to the midline to visualize the back muscles superior to the transverse process. A 22-G short bevel needle (spinocan, B.Braun, melsungen AG, Germany) will be inserted in cranial-caudal direction until it make contact with the transverse process. Confirmation of the correct position of the tip of the needle is by injection of 1 ml saline causing hydrodisscetion between the erector spinae muscle and the transverse process. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine is injected.The same procedure is done on the other side of the back.
Receives: Procedure: ESPB and TAP block
TAP Transversus Abdominis Plane BlockActive comparatorbilateral TAP block: while the patient in the supine position, a linear ultrasound (US) transducer (Phillips Saronno Italy) is placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis. A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) is introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine is injected causing an elliptical separation of the two muscles. The same procedure is done on the other side.
Receives: Procedure: ESPB and TAP block

What is being measured

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

  1. duration of analgesia of the two blocks

    time

    Measured: 24 hours

Secondary outcomes (7)
  1. Visual analogue scale

    Visual analogue scale for pain

    Measured: immediatiy in pacu

  2. Visual analogue scale

    Visual analogue scale for pain

    Measured: 4 hours

  3. Visual analogue scale

    Visual analogue scale for pain

    Measured: 8 hours

  4. Visual analogue scale

    Visual analogue scale for pain

    Measured: 12 hours

  5. Visual analogue scale

    Visual analogue scale for pain

    Measured: 24 hours

  6. the first request to analgesia

    duration

    Measured: 24 hours

  7. total analgesic consumption

    amount

    Measured: 24 hours

Timeline

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

  1. First posted11 Jul 2019
  2. Study start8 Jul 2019
  3. Primary completion31 Dec 2019
  4. Study completion1 Jan 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
Model description
Parallel Assignment
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04016688
Sponsor's protocol ID
R 126
Status last verified
Jan 2020
First submitted
8 Jul 2019
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ueshima H, Otake H. Similarities Between the Retrolaminar and Erector Spinae Plane Blocks. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):123-124. doi: 10.1097/AAP.0000000000000526. No abstract available.

    PubMed 27997492
  • Leung AY. Postoperative pain management in obstetric anesthesia--new challenges and solutions. J Clin Anesth. 2004 Feb;16(1):57-65. doi: 10.1016/j.jclinane.2003.02.012.

    PubMed 14984863

Questions about this trial

What is this clinical trial studying?

A study testing ESPB and TAP block in people with Postoperative Pain, run by Fayoum University at 3 sites 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 2 inclusion and 6 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 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

duration of analgesia of the two blocks (time frame: 24 hours). 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 NCT04016688, which also lists 2 linked publications.

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 22 Jan 2020; AzTrials last refreshed its copy on 30 Oct 2026.

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