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Postoperative PainPhase 2NCT04715165

Analgesia After Laparoscopic Cholecystectomy

A Phase 2 study testing USG-STAP with bupivacaine and dexmedetomidine and IP bupivacaine and dexmedetomidine in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Pain after laparoscopic cholecystectomy is common and may lead to delayed hospital discharge. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Postoperative Pain
What is being tested?
USG-STAP with bupivacaine and dexmedetomidine and IP bupivacaine and dexmedetomidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteEgypt
Study dates
7 Aug 2021to 15 Feb 2022
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing elective LC under general anesthesia, aged from 20 to 65 years old.

Who cannot join

  • Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
  • Altered conscious level
  • Pregnancy
  • Body mass index (BMI > 35)
  • Patients who have difficulty understanding the study protocol 6- Patients who have any known contraindication to study medications 7- Patient refusal.

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Assiut University

    Asyut, 71515

    Seham M Moeen, M.D., 01006386324 ext. 02, seham.moeen@aun.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Comparison of Subcostal Transversus Abdominis Block With Intraperitoneal Instillation of Bupivacaine and Dexmedetomidine for Pain Relief After Laparoscopic Cholecystectomy: A Randomized Trial

Pain after laparoscopic cholecystectomy is common and may lead to delayed hospital discharge.

Read the detailed description

Laparoscopic cholecystectomy (LC) is very commonly performed nowadays, and it has now completely replaced open cholecystectomy in the management of biliary lithiasis. Although it is minimally invasive surgery, pain in postoperative period is always major concern as it increases perioperative stress, morbidity, and hospital stay.

There are two components involved in pain after LC; the visceral component is due to tissue damage in anterior abdominal wall during the insertion of trocar and shoulder tip pain due to diaphragmatic irritation caused by Spillage of blood or bile and peritoneum stretching caused by pneumoperitoneum.

There are several methods employed in the management of postoperative pain after LC such as conventional systemic analgesics, including paracetamol, non-steroidal anti-inflammatory drugs, systemic opioids, thoracic epidural analgesia, low-pressure pneumoperitoneum, and warm air with all having its side effects .

Transversus abdominis plane (TAP) block has got a substantial role in postoperative analgesia after abdominal surgery because deposition of local anesthetics in transversus abdominis fascial plane can produce sensory block over the anterior abdominal wall from T7 to L1. Many clinical studies reported beneficial effects of TAP but results were mainly connected to lower abdominal surgery. Since the major part of pain after LC derives from abdominal wall incisions, some trials investigated TAP block as potential analgesic option. Some studies showed that TAP block can reduce opioid requirements and pain scores but the results were not conclusive enough because many differences in study designs.

The ultrasound-guided (USG) subcostal transversus abdominis plane block (STAP), first described by Hebbard 2008, is a variation of TAP which successfully solve the problem of unreliable supraumbilical distribution of the block. Results obtained in a few small studies showed significantly better analgesia after LC compare to traditional opioid analgesia, port-site infiltration and standard TAP.

Intraperitoneal (IP) instillation of local anaesthetics around the operative site is used as an analgesic technique on the assumption that conduction from visceral sites is obstructed and may lessen the intensity of referred pain to the shoulder (C3, C4) which results from irritation of diaphragmatic innervations, i.e., phrenic nerve (C3, C4, C5) and diaphragmatic stretching due to gaseous distension, in the postoperative period. Narchi I' et al., as early as in 1991 had reported that instillation of local anaesthetic (80 mL of bupivacaine 0.125%, epinephrine (1:200,000) under the right diaphragm reduced shoulder pain after minor gynaecologic laparoscopy.

Dexmedetomidine is a selective, short acting, agonist of the α2-adrenergic receptors. It has high affinity to α2-adrenergic receptors (more than eight-fold) and lower affinity to α1-receptors, compared with other α2-agonists agents, besides its great selectivity to α2A-adrenergic receptors, which is responsible for its analgesic effect. It has been used clinically as an adjunct to anesthesia and analgesia, and it is useful for painful surgical procedure and ICU sedation.

Being tested
USG-STAP with bupivacaine and dexmedetomidine, IP bupivacaine and dexmedetomidine
Medical subject headings
Pain, Postoperative

What participants receive

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

  • USG-STAP with bupivacaine and dexmedetomidineDrug

    Patients will receive USG-STAP block with bupivacaine and dexmedetomidine in both sides ten minutes before skin incision and intraperitoneal normal saline

  • IP bupivacaine and dexmedetomidineDrug

    Patients will receive bupivacaine and dexmedetomidine through the intraperitoneal route and USG-STAP block with normal saline at the end of surgery

Study groups in NCT04715165
Study groupRoleWhat they receive
Group IActive comparatorPatients will receive USG-STAP block with bupivacaine and dexmedetomidine in both sides ten minutes before skin incision and intraperitoneal normal saline.
Receives: Drug: USG-STAP with bupivacaine and dexmedetomidine
Group IIPlacebo comparatorPatients will receive bupivacaine and dexmedetomidine through the intraperitoneal route and USG-STAP block with normal saline at the end of surgery
Receives: Drug: IP bupivacaine and dexmedetomidine

What is being measured

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

  1. The intensity of postoperative pain

    Assessed by the numerical rating pain scale (NRS)

    Measured: 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 posted20 Jan 2021
  2. Study start7 Aug 2021
  3. Primary completion15 Feb 2022 (estimated)
  4. Study completion15 Feb 2022 (estimated)

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04715165
Sponsor's protocol ID
SM 1, 2021
Status last verified
Aug 2021
First submitted
15 Jan 2021
Last updated
13 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • El Sabour AIA, Youssef HA, Ismail EA, Ahmed DH. Comparison of subcostal transversus abdominis block with intraperitoneal instillation of bupivacaine and dexmedetomidine for pain relief after laparoscopic cholecystectomy, randomized double blinded controlled study. BMC Anesthesiol. 2025 Nov 14;25(1):560. doi: 10.1186/s12871-025-03412-4.

    PubMed 41239226

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing USG-STAP with bupivacaine and dexmedetomidine and IP bupivacaine and dexmedetomidine in people with Postoperative Pain, run by Assiut 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 5 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: status not confirmed, as of the sponsor's last update on 13 Aug 2021. 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. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Seham M Moeen, MD (01006386324 ext. 02, seham.moeen@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The intensity of postoperative pain (time frame: 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 NCT04715165, 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 13 Aug 2021; AzTrials last refreshed its copy on 30 Oct 2026.

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