Skip to content

"Dexa vs Dexmedetomidine With Bupivacaine in TAP Block for Laparotomy Analgesia

Comparison Of Dexamethasone Versus Dexmedetomidine As An Adjuvant To 0.25% Bupivacaine In Ultrasound Guided Tap Block On Post-Op Analgesia Duration In Patients Undergoing Laparotomy

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07590752
Enrollment
96
Registered
2026-05-15
Start date
2024-03-03
Completion date
2026-07-04
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparotomy, Opioid Use, Pain, Postoperative

Brief summary

Transversus abdominis plane block is a regional anesthetic technique which blocks the abdominal neural afferents by introducing local anesthetic into the neuro-fascial plane between the internal oblique and the transversus abdominis muscle and gives analgesia from the skin to parietal peritoneum. There are studies showing evidence of improved post operative analgesia with addition of adjuvants such as dexmedetomidine or dexamethasone in comparison with plane local anesthesia in terms of time to rescue analgesia and the overall quantity of analgesic used post operatively.

Detailed description

After approval of synopsis by the research board and ethical committee and Research department CPSP Karachi, the data collection process will begin. The study will be conducted in the Anesthesia Department of Sahiwal Teaching Hospital Sahiwal. Written informed consent will be obtained from all the patients included in the study. Patients aged between 25 to 65 years, belonging to ASA class-I and class-II, scheduled for laparotomy will be divided into 2 groups of 48 patients each: * Group A: Patients who will receive transversus abdominis plane block with - 18ml Bupivacaine 0.25%+ 2 ml Dexamethasone 8mg. * Group B: Patients who will receive transversus abdominis plane block with - 18ml Bupivacaine 0.25%+ 2ml Dexmedetomidine (1µg/Kg diluted in 2ml saline). At the end of the surgery, bilateral Ultrasound (U/S) guided TAP block will be performed in both groups using ultrasound machine. The patient will be in supine position and a high frequency linear probe will be placed transverse to abdominal wall between the costal margin and iliac crest at mid axillary line. The needle will be introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transverse abdominis muscles. Upon reaching the plane and after negative aspiration test for blood, 2ml of saline will be injected to confirm correct needle position, after which the patient will receive the TAP block as per the group allocation. Patients will be observed for any complication like signs of local anesthetic toxicity or hematoma formation at site of block. In PACU and surgical unit, Visual Analogue Scale Score (VAS) will be recorded at arrival to PACU 2, 4, 6, 12 and 24 hours post-operative. A VAS score of ≤3 will be considered satisfactory pain relief. If patients have inadequate analgesia, supplementary rescue analgesia will be given in the form of IV ketorolac 30mg at VAS ≥4. The time of first request for rescue analgesic will be recorded. Post-operative nausea and vomiting will be documented according to a categorical scale: 0 none, 1 nausea, 2 vomiting, 3 nausea and vomiting. Hemodynamic variables such as heart rate and mean arterial pressure will be recorded. The primary outcome will be to compare the time for first rescue analgesia. The secondary outcome will be assessment of postoperative pain using VAS score at 2, 6, 12, 18 and 24 hrs.

Interventions

DRUGBupivacaine Hcl 0.25% Inj_#1

At the end of the surgery, bilateral Ultrasound (U/S) guided TAP block will be performed using ultrasound machine. The patient will be in supine position and a high frequency linear probe will be placed transverse to abdominal wall between the costal margin and iliac crest at mid axillary line. The needle will be introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transverse abdominis muscles. Upon reaching the plane and after negative aspiration test for blood, 2ml of saline will be injected to confirm correct needle position, after which the patient will receive the TAP block as per the group allocation.

DRUGBupivacaine Hcl 0.25% Inj_#2

At the end of the surgery, bilateral Ultrasound (U/S) guided TAP block will be performed in both groups using ultrasound machine. The patient will be in supine position and a high frequency linear probe will be placed transverse to abdominal wall between the costal margin and iliac crest at mid axillary line. The needle will be introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transverse abdominis muscles. Upon reaching the plane and after negative aspiration test for blood, 2ml of saline will be injected to confirm correct needle position, after which the patient will receive the TAP block as per the group allocation.

Sponsors

Sahiwal medical college sahiwal
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

* Group A: Patients who will receive transversus abdominis plane block with - 18ml Bupivacaine 0.25%+ 2 ml Dexamethasone 8mg. * Group B: Patients who will receive transversus abdominis plane block with - 18ml Bupivacaine 0.25%+ 2ml Dexmedetomidine (1µg/Kg diluted in 2ml saline).

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients undergoing laparotomy. * Patients aged 25 to 65 years. * Both genders. * Patients with ASA Class I, II.

Exclusion criteria

* Patients who do not give consent. * Patients with Comorbidities like DM, HTN, CKD, CLD. * Patients with bleeding disorders. * Infection at site of injection. * Allergy to any drug, local anaesthetic, or other drugs used. * Patients with polytrauma.

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain24 hoursDuration of postop analgesia

Countries

Pakistan

Contacts

CONTACTDr Maryam Mumtaz, MBBS
Maryamsumra3@gmail.com00923336238201
CONTACTDr Muhammad Shahid
shahidnishtar@gmail.com00923336173056
STUDY_DIRECTORAdeel Riaz, MD

Sahiwal medical college sahiwal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026