NCT07254130

Brief Summary

To compare the mean duration of postoperative analgesia following addition of dexmedetomidine to ropivacaine versus plain ropivacaine in ultrasound guided rectus sheath block in patients undergoing midline laparotomies

Trial Health

87
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 28, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
Last Updated

November 28, 2025

Status Verified

October 1, 2025

Enrollment Period

6 months

First QC Date

November 19, 2025

Last Update Submit

November 19, 2025

Conditions

Midline Laparotomy

Outcome Measures

Primary Outcomes (1)

  • Mean duration of analgesia

    Assessed using the visual analogue score(VAS) ranging from 0-10 (0=no pain , 10= most severe unbearable pain)

    Baseline , 30 minutes , 2 hours, 4 hours , 6 hours , 8 hours , 12 hours , 24 hours

Study Arms (2)

Ropivacaine only group

ACTIVE COMPARATOR
Procedure: Rectus Sheath Block

Dexmedetomedine combined with ropivacaine group

ACTIVE COMPARATOR
Procedure: Rectus Sheath Block

Interventions

Rectus Sheath BlockPROCEDURE

In Dexmedetomedine combined with ropivacaine group, under ultrasound guidance, the needle will be advanced posterior to the rectus muscle, and 20 ml of 0.25% ropivacaine mixed with 1ug/kg body weight will be injected to hydrodissect the rectus muscle from the posterior sheath. In ropivacine only group, under ultrasound guidance, the needle will be advanced posterior to the rectus muscle, and 20 ml of 0.25% ropivacaine will be injected to hydrodissect the rectus muscle from the posterior sheath.

Dexmedetomedine combined with ropivacaine groupRopivacaine only group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with age 30 - 60 years.
  • Patients that will be scheduled for laparotomy under general anesthesia.
  • ASA (American Society of Anesthesiologist) s

You may not qualify if:

  • Patient who will refuse for participation in study.
  • Infection at site of Rectus Sheath block.
  • History of any addiction.
  • Sensitivity to the local anesthetics.
  • Patient with pre-existing coagulation abnormalities INR more than 1.5.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahawal Victoria Hospital, Bahawalpur

Bahawalpur, Punjab Province, 63100, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 28, 2025

Study Start

February 28, 2025

Primary Completion

August 28, 2025

Study Completion

September 20, 2025

Last Updated

November 28, 2025

Record last verified: 2025-10

Locations

PA(1)