Comparison of Pain ReliefofBupivacaineWith Dexmedetomidine and Bupivacaine Alone in TransversusAbdominisPlane Block For Postoperative Anelgesia in Patients Undergoing Abdominal Surgeries

NCT05244252 | Unknown Early Phase 1

• 1 other identifier: SZMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain related to abdominal surgeries poses significant burden on the healthcare system, in terms of increased use of different analgesics, delayed ambulation, pulmonary complications, DVT, and prolonged hospital stays. Abdominal wall is major source of pain and there have been much debate in the past to bring up the effective, low cost and prolong pain relief to the patients after abdominal surgeries. But yet a consensus has to be developed about which analgesic to be used for most efficient and prolonged pain relief. Though, many studies have been done on TAP block and different combinations have been tried in TAP block, like, dexmedetomidine, midazolam, ropivacaine, but we still lack local data. Recent studies have shown very promising results in terms of efficacy and duration of block by mixing bupivacaine with dexmedetomidine, alongwith minimal side effects to the patients. This randomised control trial will enroll 88 patients coming to Anesthesia department of Sheikh Zayed Hospital Rahim Yar Khan, for abdominal surgeries, judged on the basis of inclusion and exclusion criteria, into two groups of equal sizes. TAP block will be given to all patients bilaterally at the end of procedure after extubation in operation room. One group will be given bupivacainemixed with dexmedetomidine, while the other group will receive bupivacaine only, and they will be followed upto 12 hours postoperatively in post surgical ICU. Study protocol will be according to the ethical standards declared by Helsinki. For both the groups, HR, BP, SpO2,VAS score,rescue analgesia and sedation score stated on the clinical proforma will be assessed. After appropriate sample collection,patient data will be sorted in SPSS v23 through which statistical analysis using corresponding statistical functions and tests will be done.Quantitative data (like heart rate, mean arterial pressure, VAS score etc.) will be analysed using t-test. For qualitative variable(pain relief, bradycardia nausea etc.)chi-square test will be applied. P value \</= 0.05 will be considered significant. Results of the study will be summarized and presented in final thesis.

Conditions

Pain Relief in Post Operative Patient

Keywords

Dexmeditomidine, bupivacaine, VAS, remsay sedation score

Outcome Measures

Primary Outcomes (1)

• Visual analogue score

  It is a scale from 0-10 showing minimal pain on 0 and maximum pain on 10. This score is classified in to 5 categories. 0 No Pain 1-3 Mild Pain 4-6 Moderate Pain 7-9 Severe Pain 10 very severe

  12 hours post operative pain will be followed

Study Arms (2)

Group A

EXPERIMENTAL

Two drugs dexmeditomidine and bupivacaine will be given in TAP block

Drug: dexmeditomidine and bupivacaine

Group B

ACTIVE COMPARATOR

One drug bupivacaine will be given in TAP block

Drug: Bupivacaine

Interventions

dexmeditomidine and bupivacaine DRUG

Transversus abdominis plane block will be given bilaterally

Group A

Bupivacaine DRUG

bupivacaine

Group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who will give written informed consent
• ASA I \&II
• Age between 21-45 years
• Patients undergoing abdominal surgeries
• Patients understanding VAS

You may not qualify if:

• Patients allergic to bupivacaine or dexmeditomidine
• Complicated procedure
• History of coagulopathy
• History of chronic use of pain medications

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

Alina Zafar

Rahim Yar Khan, Punjab Province, 64200, Pakistan

RECRUITING

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

alina zafar, MBBS

CONTACT

+923126555448; docaleena786@gmail.com

Fatima Zahra, MBBS

CONTACT

+923006724677; fatimatuzahra92@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Two groups of equal size will be included in study

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: October 4, 2021
• Primary Completion: March 3, 2022
• Study Completion: April 10, 2022
• Last Updated: March 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)