NCT06076707

Brief Summary

The goal of this study's clinical trial is to compare in post-operative analgesic effectiveness of wound infiltration using bupivacaine, tramadol, and tramadol plus bupivacaine in patients undergoing elective cesarean section under spinal anesthesia. The main question the study aimed to answer is "which approach is best among the 3" all participants need to respond to the pain severity for the data collectors and they will receive treatments accordingly There will be 3 groups in the study

  • group T: for tramadol
  • group B: for bupivacaine
  • group TB : tramadol + bupivacaine

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
163

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

May 17, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2024

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

May 17, 2023

Last Update Submit

November 4, 2023

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Measuring pain severity

    Pain severity is measured by a visual analog scale(VAS) which measures pain severity from zero to ten

    starting from discharging from operation table to the 2nd day of surgery ( for 48 hours)

Study Arms (3)

Tramadol (T) group

EXPERIMENTAL

Participants will be infiltrated with only 200mg tramadol around the wound.

Drug: bupivacain-tramadol

Bupivacain (B) group

PLACEBO COMPARATOR

participants will be infiltrated with only bupivacaine around the wound

Drug: bupivacain-tramadol

Tramadol + bupivacain ( T+B) group

EXPERIMENTAL

The participants will be infiltrated with tramadol and bupivacaine which are mixed together in the same syringe.

Drug: bupivacain-tramadol

Interventions

bupivacain-tramadolDRUG

Comparing effectiveness of tramadol and bupivacaine for postoperative pain treatment and prevention for cesarian section

Bupivacain (B) groupTramadol (T) groupTramadol + bupivacain ( T+B) group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe stud focused on a mother giving birth by incision (cesarian section)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women age between 18 and 35
  • ASA risk class I-II

You may not qualify if:

  • \- Chronic pain diagnosis
  • ASA above II
  • Comorbidities (Anemia, DM, HTN, Arthritis)
  • Known allergy to bupivacaine, tramadol
  • History of alcohol, opiate, or other drug abuse
  • Use of preoperative anti-pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dessie comprehensive specilized hospital

Dessie, Amhara, 801103, Ethiopia

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Woldemichael

    Wollo Universty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aynalem Bf Woldemichael, MSC

CONTACT

251916583316aynalembefkadu31@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The data collector and the investigator will be blind for the study while the patient is not.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Quality control coordinater, Research team leader, lecturer in anesthesia

Study Record Dates

First Submitted

May 17, 2023

First Posted

October 11, 2023

Study Start

November 30, 2023

Primary Completion

May 30, 2024

Study Completion

June 2, 2024

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

ET(1)