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Menstrual Phase and Postoperative Pain

Primary Purpose

Acute Postoperative Pain, Chronic Postoperative Pain

Status

Completed

Phase

Early Phase 1

Locations

Turkey

Study Type

Interventional

Intervention

HAD scale

The SF 12 test

Visual analogue score

About this trial

This is an interventional prevention trial for Acute Postoperative Pain focused on measuring chronic postoperative pain, menstrual cycle

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Women with a negative urine pregnancy test

Exclusion Criteria:

Patients with pre-existing pain syndromes
Patients using routinely using opioids
Patients using hormone preparations in the last 6 months
Patients with hysterectomy
Patients breastfeeding in the previous 6 months
Patients with body mass index >35 kg/m2

Sites / Locations

Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

follicular phase

luteal phase

Arm Description

Visual anlogue score vas used to evaluate pain. The anxiety/depression scale (HAD) was used to assess anxiety and depression. The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.

Outcomes

Primary Outcome Measures

Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale

Secondary Outcome Measures

The anxiety and depression was evaluated with Hospital anxiety and depression scale.

Full Information

NCT ID

NCT02137135

First Posted

May 12, 2014

Last Updated

May 12, 2014

Sponsor

Aydin Adnan Menderes University

1. Study Identification

Unique Protocol Identification Number

NCT02137135

Brief Title

Menstrual Phase and Postoperative Pain

Official Title

The Influence of the Menstrual Cycle on Acute and Persistent Pain After Laparoscopic Cholecystectomy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aydin Adnan Menderes University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Fluctuations of female sex hormones during the menstrual cycle influence pain perception. Endogenous pain is pronounced in the follicular phase of the menstrual cycle. The investigators tested the primary hypothesis that the women having surgery during their follicular phase have more acute pain and require more opioids than those in the luteal phase, and secondarily the investigators tested that women who have surgery during their follicular phase have more incisional pain at 3 month postoperatively.

Detailed Description

127 adult females having laparoscopic cholecystectomy were randomized to have surgery during the luteal or follicular phase of their menstrual cycle. Standardized anesthesia and pain management regimen was given to all patients. Pain and analgesic consumption were evaluated in PACU and every four hours in first 24 hours. Adverse effects were also questioned every four hours. Time to oral intake and ambulation were recorded. Post-surgical pain, hospital anxiety and depression scale, and SF-12 questionnaire were also evaluated at 1- and 3-month visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Postoperative Pain, Chronic Postoperative Pain

Keywords

chronic postoperative pain, menstrual cycle

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

follicular phase

Arm Type

Experimental

Arm Description

Visual anlogue score vas used to evaluate pain. The anxiety/depression scale (HAD) was used to assess anxiety and depression. The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.

Arm Title

luteal phase

Arm Type

Active Comparator

Arm Description

Visual anlogue score vas used to evaluate pain. The anxiety/depression scale (HAD) was used to assess anxiety and depression. The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.

Intervention Type

Other

Intervention Name(s)

HAD scale

Other Intervention Name(s)

The anxiety/depression scale

Intervention Description

The anxiety/depression scale (HAD) was used to assess anxiety and depression.

Intervention Type

Other

Intervention Name(s)

The SF 12 test

Other Intervention Name(s)

SHORT FORM 12

Intervention Description

The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.

Intervention Type

Other

Intervention Name(s)

Visual analogue score

Other Intervention Name(s)

VAS score

Intervention Description

Visual analogue score vas used to evaluate pain.

Primary Outcome Measure Information:

Title

Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale

Time Frame

3 months

Secondary Outcome Measure Information:

Title

The anxiety and depression was evaluated with Hospital anxiety and depression scale.

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

Quality of life was evaluated with SF 12 test.

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women with a negative urine pregnancy test Exclusion Criteria: Patients with pre-existing pain syndromes Patients using routinely using opioids Patients using hormone preparations in the last 6 months Patients with hysterectomy Patients breastfeeding in the previous 6 months Patients with body mass index >35 kg/m2

Overall Study Officials: