Postoperative PainNCT03398564
Erector Spinae Plan Block for Postoperative Analgesia
A study testing Erector Spinae Plan Block and Oblique subcostal TAP in people with Postoperative Pain, run by Al Jedaani Hospital at 1 site in Saudi Arabia.
Trial summary
Laparoscopic cholecystectomy is a widely employed procedure in ambulatory surgery. Pain after laparoscopic cholecystectomy arises significantly from port site incisions in the anterior abdominal wall. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector Spinae Plan Block and Oblique subcostal TAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Jan 2018to 30 Nov 2018
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 60 ASA I- II adult patients
- 20-60 years old
- elective laparoscopic cholecystectomy
- Body mass index (BMI) less than 35
- Port sites at or above thoracic T 10 dermatome
Who cannot join
- Allergy to amino-amide local anesthetics
- Presence of coagulopathy
- Local skin infection at the needle puncture sites
- Preoperative chronic dependence upon opioid and NSAID medications
- Liver or renal insufficiency
- History of psychiatric or neurological disease
Show all 9Show fewer
- Deafness
- previous open surgery that need the conversion of laparoscopic to open surgery or manipulations more than expected with more tissue trauma
- American Society of Anesthesiologists (ASA) above Class II
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Al Jedaani group of hospitals
Jeddah, Meccah, 21462/7500
About this study
Official title: Efficacy of Ultrasound-Guided Erector Spinae Plan Block on Postoperative Pain After Laparoscopic Cholecystectomy Under General Anesthesia. Randomized, Controlled Trial
Laparoscopic cholecystectomy is a widely employed procedure in ambulatory surgery. Pain after laparoscopic cholecystectomy arises significantly from port site incisions in the anterior abdominal wall. Innervation of the anterior abdominal wall is segmentally supplied by pain afferents in the plane of fascia between transversus abdominis and the internal oblique muscles. Opioids analgesia is used to control postoperative pain, but it carries the risk of increased nausea and vomiting, ileus and sedation that may delay hospital discharge.
Several techniques have been tried as.neuroaxial narcotics, intraperitoneal lavage of local anesthetic and transversus abdominis plan (TAP) block and successfully reduced opioid use and improve postoperative analgesia.
Read more
The ultrasound-guided erector spinae plan(ESP) block is a recently described technique which produces reliable unilateral analgesia at thoraco-lumbar dermatomes. ESP block carries the advantages of being simple, safe, easily recognizable by ultrasound, and a catheter can be threaded to extend the duration of analgesia.
Few case series reported the efficacy of (US)-guided ESP blocks in reducing postoperative pain and opioids consumption.
Because of that, the investigators aimed to test the hypothesis that US-guided ESP blocks can decrease opioid consumption during the first 24 h after of laparoscopic cholecystectomy in comparison with the conventional systemic analgesia.
- Conditions
- Postoperative Pain
- Being tested
- Erector Spinae Plan Block, Oblique subcostal TAP
- Keywords
- Erecror Spinae Plan Block, postoperative pain, Laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plan BlockProcedure or surgery
The trocar site incision was done 15 minutes after the block in the three groups. The skin was disinfected with chlorhexidine solution, and the high-frequency transducer was isolated with a sterile disposable plastic cover and gel. The patient was placed in lateral position. A high-frequency linear ultrasound probe was placed longitudinally lateral to the T8 spinous process by 3 cm. After identification of the 3 muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle was introduced in a cephalo-caudal orientation. The needle tip was positioned fascial plane between rhomboid major and erector spinae muscles. Hydrodissection by 1-2 ml of normal saline to visualize the plan, then deposition of local anesthetic was done. A total of 20 mL of 0.25% bupivacaine was injected here. The same procedure was repeated on the other side.
Oblique subcostal TAPProcedure or surgery
ultrasound-guided bilateral oblique subcostal TAP block with bupivacaine 0.25% (20ml on each side)
| Study group | Role | What they receive |
|---|---|---|
| Group I (Control) | Placebo comparator | ultrasound guided Bilateral Erector Spinae Plan Block using isotonic saline Receives: Procedure: Erector Spinae Plan Block |
| Group II (ESP) | Active comparator | ultrasound guided Bilateral Erector Spinae Plan Block with bupivacaine 0.25% Receives: Procedure: Erector Spinae Plan Block |
| Group III(OSTAP) | Active comparator | Ultrasound-guided bilateral oblique subcostal TAP block Receives: Procedure: Oblique subcostal TAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
It was calculated as equivalent morphine dose to the opioid analgesia consumed
Measured: 24 hours postoperatively.
Secondary outcomes (4)
Quality of analgesia
comparing visual analog scores (VAS) every two hours after surgery
Measured: Every 2 hours for 24 hours postoperatively
The intraoperative fentanyl
(µg) required during surgery
Measured: 2 hours
equivalent morphine dose in the recovery unit (PACU)
equivalent morphine dose in the recovery unit (PACU)
Measured: one hour
Erector spinae plan block complications
local anesthetic systemic toxicity, vascular injury, and intravascular injection of local anesthetic
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start10 Jan 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al Jedaani Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398564
- Sponsor's protocol ID
- 1/12
- Status last verified
- Oct 2018
- First submitted
- 29 Dec 2017
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ibrahim M. Erector Spinae Plane Block in Laparoscopic Cholecystectomy, Is There a Difference? A Randomized Controlled Trial. Anesth Essays Res. 2020 Jan-Mar;14(1):119-126. doi: 10.4103/aer.AER_144_19. Epub 2020 Feb 3.
PubMed 32843804
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-Guided Erector Spinae Plan Block on Postoperative Pain After Laparoscopic Cholecystectomy Under General Anesthesia. Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03398564
- Acronym / sponsor ID
- 1/12
- Conditions
- Postoperative Pain
- Keywords
- Erecror Spinae Plan Block, postoperative pain, Laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Al Jedaani HospitalUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic cholecystectomy is a widely employed procedure in ambulatory surgery. Pain after laparoscopic cholecystectomy arises significantly from port site incisions in the anterior abdominal wall. Innervation of the anterior abdominal wall is segmentally supplied by pain afferents in the plane of fascia between transversus abdominis and the internal oblique muscles. Opioids analgesia is used to control postoperative pain, but it carries the risk of increased nausea and vomiting, ileus and sedation that may delay hospital discharge.
Several techniques have been tried as.neuroaxial narcotics, intraperitoneal lavage of local anesthetic and transversus abdominis plan (TAP) block and successfully reduced opioid use and improve postoperative analgesia.
The ultrasound-guided erector spinae plan(ESP) block is a recently described technique which produces reliable unilateral analgesia at thoraco-lumbar dermatomes. ESP block carries the advantages of being simple, safe, easily recognizable by ultrasound, and a catheter can be threaded to extend the duration of analgesia.
Few case series reported the efficacy of (US)-guided ESP blocks in reducing postoperative pain and opioids consumption.
Because of that, the investigators aimed to test the hypothesis that US-guided ESP blocks can decrease opioid consumption during the first 24 h after of laparoscopic cholecystectomy in comparison with the conventional systemic analgesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (Control) | Placebo comparator | Procedure: Erector Spinae Plan Blockultrasound guided Bilateral Erector Spinae Plan Block using isotonic saline |
| Group II (ESP) | Active comparator | Procedure: Erector Spinae Plan Blockultrasound guided Bilateral Erector Spinae Plan Block with bupivacaine 0.25% |
| Group III(OSTAP) | Active comparator | Procedure: Oblique subcostal TAPUltrasound-guided bilateral oblique subcostal TAP block |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 60 ASA I- II adult patients
- 20-60 years old
- elective laparoscopic cholecystectomy
- Body mass index (BMI) less than 35
- Port sites at or above thoracic T 10 dermatome
Key exclusion criteria (9 listed)
- Allergy to amino-amide local anesthetics
- Presence of coagulopathy
- Local skin infection at the needle puncture sites
- Preoperative chronic dependence upon opioid and NSAID medications
- Liver or renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plan BlockThe trocar site incision was done 15 minutes after the block in the three groups. The skin was disinfected with chlorhexidine solution, and the high-frequency transducer was isolated with a sterile disposable plastic cover and gel. The patient was placed in lateral position. A high-frequency linear ultrasound probe was placed longitudinally lateral to the T8 spinous process by 3 cm. After identification of the 3 muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle was introduced in a cephalo-caudal orientation. The needle tip was positioned fascial plane between rhomboid major and erector spinae muscles. Hydrodissection by 1-2 ml of normal saline to visualize the plan, then deposition of local anesthetic was done. A total of 20 mL of 0.25% bupivacaine was injected here. The same procedure was repeated on the other side. | Procedure or surgery | Group I (Control), Group II (ESP) |
| Oblique subcostal TAPultrasound-guided bilateral oblique subcostal TAP block with bupivacaine 0.25% (20ml on each side) | Procedure or surgery | Group III(OSTAP) |
Primary outcome
Morphine consumption
Time frame: 24 hours postoperatively.
It was calculated as equivalent morphine dose to the opioid analgesia consumed
4 secondary outcomes
Quality of analgesia
Time frame: Every 2 hours for 24 hours postoperatively
The intraoperative fentanyl
Time frame: 2 hours
equivalent morphine dose in the recovery unit (PACU)
Time frame: one hour
Erector spinae plan block complications
Time frame: 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Derived from this study: PubMed 32843804Ibrahim M. Erector Spinae Plane Block in Laparoscopic Cholecystectomy, Is There a Difference? A Randomized Controlled Trial. Anesth Essays Res. 2020 Jan-Mar;14(1):119-126. doi: 10.4103/aer.AER_144_19. Epub 2020 Feb 3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plan Block and Oblique subcostal TAP in people with Postoperative Pain, run by Al Jedaani Hospital at 1 site in Saudi Arabia.
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 5 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 26 Dec 2018. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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?
Morphine consumption (time frame: 24 hours postoperatively.). 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 NCT03398564, 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 26 Dec 2018.