NCT05831501

Brief Summary

Transverse abdominis plane (TAP) block is an effective method to manage postoperative pain in patients with midline abdominal wall incisions. It is used frequently in many lower abdominal surgeries however its use after caesarean section is still new, and fewer studies are available. We conducted this study to see the analgesic effect of TAP block after caesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

April 13, 2023

Last Update Submit

April 25, 2023

Conditions

Keywords

TAP block, C-section, Spinal anesthesia, localized field effects, analgesia, Postoperative pain and Opioids

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

    within 24hours after surgery

    24 hours post cesarean section

Secondary Outcomes (3)

  • Pain intensity Score

    from end of secarean section till 24 post operative hours

  • Vomiting

    Within 24hours after surgery

  • Duration of First Rescue Analgesia

    Within 24hours after surgery

Study Arms (2)

TAP block group

EXPERIMENTAL

At the end of the cesarean section, a TAP block will be given by Injecting of 20ml 0.25% Bupivacaine on both sides of the midline using ultrasound-guided subcostal approach

Procedure: Trans abdominis plane block

Placebo group

NO INTERVENTION

At the end of the cesarean section, 20 ml of saline will be injected on both sides of the midline

Interventions

Ultrasound guided infiltration of local anaesthetic bupivacaine via 22G Quincke needle between internal oblique and trans abdominis muscle layers in abdominal wall.

TAP block group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Elective Caesarean section
  • ASA 1-3
  • yrs to 45yrs

You may not qualify if:

  • Emergency Surgery
  • known allergy to local anaesthetic
  • severe pre-eclampsia
  • placenta accreta
  • ASA 4
  • Coagulopathy
  • Hemodynamically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combined Military Hospital

Sargodha, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

April 13, 2023

First Posted

April 26, 2023

Study Start

June 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations