NCT06156657

Brief Summary

many methods were considered to control postoperative pain in laparoscopic bariatic surgery including non steroidal anti-inflammatory drugs, opioids and neuraxial block but subcostal (TAP) block has provided good analgesic effect when used as a part of multimodal analgesia in bariatric surgery due to lack of visceral block

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

November 26, 2023

Last Update Submit

November 26, 2023

Conditions

Postoperative Pain

Keywords

subcostal TAPlaparoscopicsleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain control

    by using VAS score

    9 months

Secondary Outcomes (2)

  • postoperative 24 hour opioid consumption

    9 months

  • postoperative nausea and vomiting

    9 months

Study Arms (2)

TAP group

ACTIVE COMPARATOR

patients candidate for laparoscopic sleeve gastrectomy to receive GA and subcostal TAP block to control postoperative pain and minimize opioid consumption

Other: subcostal TAP block

Control group

NO INTERVENTION

healthy controls candidate for laparoscopic sleeve gastrectomy to receive GA only opioids were used

Interventions

subcostal TAP blockOTHER

Comparison between subcostal TAP block and opioids for postoperative pain after laparscopic sleeve gastrectomy

TAP group

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-60 years
  • ASA Ι-ΙΙ
  • BMI \>35

You may not qualify if:

  • Patient refusal.
  • Allergy to study drugs.
  • Infection at site of injection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Azhar University

Cairo, Naser City, 11811, Egypt

RECRUITING

Related Publications (4)

  • Basaran B, Basaran A, Kozanhan B, Kasdogan E, Eryilmaz MA, Ozmen S. Analgesia and respiratory function after laparoscopic cholecystectomy in patients receiving ultrasound-guided bilateral oblique subcostal transversus abdominis plane block: a randomized double-blind study. Med Sci Monit. 2015 May 7;21:1304-12. doi: 10.12659/MSM.893593.

    PMID: 25948166BACKGROUND

  • Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.

    PMID: 20830871BACKGROUND

  • Ganapathy S, Sondekoppam RV, Terlecki M, Brookes J, Das Adhikary S, Subramanian L. Comparison of efficacy and safety of lateral-to-medial continuous transversus abdominis plane block with thoracic epidural analgesia in patients undergoing abdominal surgery: A randomised, open-label feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):797-804. doi: 10.1097/EJA.0000000000000345.

    PMID: 26426576BACKGROUND

  • Lissauer J, Mancuso K, Merritt C, Prabhakar A, Kaye AD, Urman RD. Evolution of the transversus abdominis plane block and its role in postoperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Jun;28(2):117-26. doi: 10.1016/j.bpa.2014.04.001. Epub 2014 May 9.

    PMID: 24993433BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Ismail M Ahmed, prof

CONTACT

00201117310053ismailabdelgawad.623@azhar.edu.eg

Khaled Elsheshtawy M Sherif, lecturer

CONTACT

00201064819857khalkedsherif2@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patient and the anasthesiologist who perform postoperative pain will not know the group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DOCTOR

Study Record Dates

First Submitted

November 26, 2023

First Posted

December 5, 2023

Study Start

January 30, 2023

Primary Completion

November 30, 2023

Study Completion

December 15, 2023

Last Updated

December 5, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

IPD are planned to be coded for privacy protection

Locations

EG(1)