NCT04037878

Brief Summary

It is a randomized controlled trial to determine the total tramadol consumption after major gynecological studies. Intervention groups include TAP block or local infiltration by the surgeon. These will be compared to a control group. Total tramadol consumption will be calculated and therefore pain control will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration 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

November 20, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2020

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

2.6 years

First QC Date

June 20, 2019

Last Update Submit

January 14, 2021

Conditions

Pain, Acute

Keywords

TAP blockLocal infiltrationTramadolGynecological surgeryPain control

Outcome Measures

Primary Outcomes (1)

  • Total consumption of tramadol

    Total consumption of tramadol post operatively

    12 hours post operatively

Secondary Outcomes (5)

  • Pain score

    12 hours post operatively

  • Respiratory depression

    12 hours post operatively

  • Nausea

    12 hours post operatively

  • Sedation

    12 hours post operatively

  • Patient satisfaction

    12 hours post operatively

Study Arms (3)

TAP block group

EXPERIMENTAL

Patients in this arm will be given Transversus Abdominal Plane(TAP) block after the induction of anesthesia. They will also be given post operative patient controlled intravenous analgesia(PCIA) using tramadol.

Procedure: Transversus Abdominis Plane Block(TAP Block)Drug: PCIA Tramadol

Local infiltration

EXPERIMENTAL

Patients in this arm will be given local and intraperitoneal infiltration of local anesthetic before closure.They will also be given post operative patient controlled intravenous analgesia(PCIA) using tramadol.

Procedure: Intra-peritoneal infiltrationDrug: PCIA Tramadol

Control group

OTHER

These patients will be given post operative analgesia in the form of patient controlled intravenous analgesia(PCIA) using tramadol. Neither local infiltration nor TAP block will be administered

Drug: PCIA Tramadol

Interventions

Transversus Abdominis Plane Block(TAP Block)PROCEDURE

Under ultrasound guidance, a 22 gauge stimuplex needle will be used to approach the transversus abdominis plane and 20ml of 0.25% Bupivicaine will be infiltrated into the TAP space. This procedure will be performed on either sides once anesthesia is induced.

TAP block group
Intra-peritoneal infiltrationPROCEDURE

Before skin closure, the surgeon will infiltrate the peritoneal cavity using a mixture of bupivicaine and epinephrine

Local infiltration
PCIA TramadolDRUG

All patients will be given patient controlled intravenous analgesia using Tramadol as the drug

Control groupLocal infiltrationTAP block group

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Weight between 40 and 90kg
  • ASA(American Society of Anesthesiologists) I to III
  • Females scheduled for major gynecological surgeries(Abdominal hysterectomy, myomectomy, ovarian cystectomy, oophorectomy) through Pfannenstiel incision

You may not qualify if:

  • Refusal to participate in the study,
  • History of drug allergy to bupivacaine, tramadol or other narcotics, addiction/ tolerance to opioids,
  • Having bleeding disorders,
  • Abdominal skin infections or open wounds/ abdominal drains,
  • Previous history of failed TAP block,
  • On blood thinners or narcotic analgesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan Hospital

Karachi, Sindh, Pakistan

Location

Related Publications (2)

  • Size M, Soyannwo OA, Justins DM. Pain management in developing countries. Anaesthesia. 2007 Dec;62 Suppl 1:38-43. doi: 10.1111/j.1365-2044.2007.05296.x.

    PMID: 17937712BACKGROUND

  • Stanley G, Appadu B, Mead M, Rowbotham DJ. Dose requirements, efficacy and side effects of morphine and pethidine delivered by patient-controlled analgesia after gynaecological surgery. Br J Anaesth. 1996 Apr;76(4):484-6. doi: 10.1093/bja/76.4.484.

    PMID: 8652316RESULT

MeSH Terms

Conditions

Acute PainAgnosia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The patient is randomized according to randomization block and sealed envelops. The investigator doesn't know what study group the patient is randomized into
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

June 20, 2019

First Posted

July 30, 2019

Study Start

November 20, 2017

Primary Completion

June 23, 2020

Study Completion

June 23, 2020

Last Updated

January 15, 2021

Record last verified: 2021-01

Locations

PA(1)