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Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery

Use of Paracervical Block in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01534416
Enrollment
132
Registered
2012-02-16
Start date
2011-09-30
Completion date
2013-09-30
Last updated
2017-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Gynecologic Surgery, Paracervical Block, Postoperative Pain

Keywords

Paracervical Block, Laparoscopic Surgery, Postoperative Pain, Bupivacaine, Hysterectomy, Myomectomy, Randomized Trial

Brief summary

The purpose of this study is to determine the effectiveness of placing numbing medication around the cervix prior to performing laparoscopic gynecologic surgery in decreasing pain after surgery. The study focuses on laparoscopic hysterectomies and robotic-assisted myomectomies. It will assess whether patients who receive the medication experience less pain and require less pain medication post operatively and if it helps reduce the number of patients who require hospitalization for pain control following surgery.

Detailed description

A variety of traditionally open surgical procedures have recently become minimally invasive through the use of laparoscopic technology. Gynecologic surgeries are no exception. However, some gynecologic laparoscopic procedures are associated with significant post-operative pain, necessitating prolonged hospitalization, use of post-operative opioids, and in some cases, the development of chronic post-operative pain. Prolonged hospitalization and use of opioids pose important patient safety concerns, such as increased risk of hospital borne illnesses and medication errors; in addition, opioids may cause respiratory depression and addiction. Given the rising cost of health care there is also an economic incentive to eliminate the need for hospital admission due to post-operative pain. Preemptive analgesia involves nerve blockade or administration of pain medication systemically prior to incision to reduce post-procedure pain. Paracervical blockade is a form of preemptive analgesia. Paracervical blocks have been demonstrated to be safe and effective for obstetrical procedures in reducing post-operative pain since the 1970s. Recently they have also been shown to be efficacious for reducing post-operative pain in vaginal hysterectomy (Long et al, Int Urogynecol J (2009) 20:5-10). For the present investigation, we intend to study the effectiveness of paracervical blockade for laparoscopic and robotic-assisted laparoscopic gynecological surgery. We hypothesize that paracervical blockade prior to surgical incision will lessen levels of post-operative pain, reduce use of opioids, and decrease the number of patients requiring hospitalization for pain control. We also hypothesize that the effects may be longer lasting than the immediate post-operative period and may decrease the amount of time to return to normal activity after surgery. Using anecdotal evidence from the primary investigator, Dr. Ascher-Walsh the rate of hospitalization for laparoscopic hysterectomy (laparoscopic-assisted vaginal hysterectomy, total laparoscopic hysterectomy, laparoscopic assisted supracervical hysterectomy) is approximately 67%. In this study, we wish to decrease hospitalization with the paracervical block by 50%, thus obtaining an overall post-operative hospitalization rate of 33%. For robotic-assisted laparoscopic myomectomy, the rate of hospitalization is 50%. We wish to decrease this by 50% as well. Overall we are aiming to achieve a rate of 30% for post-operative hospitalization for pain control for laparoscopic hysterectomies and robotic myomectomies combined.

Interventions

DRUGBupivacaine

Subjects are injected paracervically with 10 ml of 0.5% bupivacaine with 1:200000 units epinephrine prior to surgical incision.

DRUGNormal Saline

Subjects are injected paracervically with 10 ml of normal saline prior to surgical incision.

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Female * Age 18 or older * Scheduled for robotic-assisted laparoscopic myomectomy or laparoscopic hysterectomy, including total and supracervical hysterectomy, laparoscopic-assisted vaginal hysterectomy * Surgery being performed for benign disease

Exclusion criteria

* Male * Women under 18 years old * Pregnancy * Suspected or known malignant disease * Immunocompromised

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Hospital Admission for Postoperative Pain ControlFour hours after conclusion of surgeryUnplanned hospital admissions and the hospital admissions at the request of the patients for pain management

Secondary

MeasureTime frameDescription
Postoperative Pain Score1and 2 hour postoperativelyPostoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff.
Postoperative Day Pain Medication UsePostoperative days 0-10Numbers of Patients Using Pain Medication on Postoperative Days 1-10. The subjects recorded at home the type and amount of pain medication they use for 10 days postoperatively.

Countries

United States

Participant flow

Recruitment details

Patients undergoing laparoscopic surgery for benign indications were enrolled between 2011 and 2013

Participants by arm

ArmCount
Bupivacaine
Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
68
Saline
Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
64
Total132

Baseline characteristics

CharacteristicTotalBupivacaineSaline
Admission Planned6 admissions5 admissions1 admissions
Age, Continuous48.1 years
STANDARD_DEVIATION 9.2
48.4 years
STANDARD_DEVIATION 9.2
47.8 years
STANDARD_DEVIATION 9.3
Body Mass Index28.1 kg/m^2
STANDARD_DEVIATION 6.4
27.2 kg/m^2
STANDARD_DEVIATION 5.7
29.1 kg/m^2
STANDARD_DEVIATION 6.9
Parity
0
59 Participants21 Participants38 Participants
Parity
1
20 Participants10 Participants10 Participants
Parity
2
41 Participants22 Participants19 Participants
Parity
≥3
26 Participants15 Participants11 Participants
Preoperative Hematocrit36.7 % of cells
STANDARD_DEVIATION 4.1
36.8 % of cells
STANDARD_DEVIATION 4
36.6 % of cells
STANDARD_DEVIATION 4.2
Race/Ethnicity, Customized
Asian
7 Participants4 Participants3 Participants
Race/Ethnicity, Customized
Black
32 Participants12 Participants20 Participants
Race/Ethnicity, Customized
Hispanic
23 Participants13 Participants10 Participants
Race/Ethnicity, Customized
Other
4 Participants2 Participants2 Participants
Race/Ethnicity, Customized
White
64 Participants36 Participants28 Participants
Sex: Female, Male
Female
132 Participants68 Participants64 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Surgical Indication
Bleeding
3 Participants2 Participants1 Participants
Surgical Indication
Bleeding & pain
9 Participants4 Participants5 Participants
Surgical Indication
Fibroids
16 Participants7 Participants9 Participants
Surgical Indication
Fibroids & bleeding
33 Participants19 Participants14 Participants
Surgical Indication
Fibroids, bleeding & pain
41 Participants18 Participants23 Participants
Surgical Indication
Other
3 Participants0 Participants3 Participants
Surgical Indication
Pain
5 Participants4 Participants1 Participants
Surgical Indication
Prolapse
22 Participants14 Participants8 Participants
Uterine Size14.0 weeks
STANDARD_DEVIATION 5.1
13.7 weeks
STANDARD_DEVIATION 5.5
14.2 weeks
STANDARD_DEVIATION 4.6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 680 / 64
other
Total, other adverse events
17 / 6816 / 64
serious
Total, serious adverse events
1 / 680 / 64

Outcome results

Primary

Number of Participants With Hospital Admission for Postoperative Pain Control

Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management

Time frame: Four hours after conclusion of surgery

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
BupivacaineNumber of Participants With Hospital Admission for Postoperative Pain ControlUnplanned admission23 Participants
BupivacaineNumber of Participants With Hospital Admission for Postoperative Pain ControlUnplanned admission for pain10 Participants
SalineNumber of Participants With Hospital Admission for Postoperative Pain ControlUnplanned admission17 Participants
SalineNumber of Participants With Hospital Admission for Postoperative Pain ControlUnplanned admission for pain11 Participants
Secondary

Postoperative Day Pain Medication Use

Numbers of Patients Using Pain Medication on Postoperative Days 1-10. The subjects recorded at home the type and amount of pain medication they use for 10 days postoperatively.

Time frame: Postoperative days 0-10

Population: missing data from 5 participants in Bupivacaine Arm and 4 in Saline Arm

ArmMeasureGroupValue (NUMBER)
BupivacainePostoperative Day Pain Medication UsePostoperative Day 75 participants
BupivacainePostoperative Day Pain Medication UsePostoperative Day 513 participants
BupivacainePostoperative Day Pain Medication UsePostoperative Day 328 participants
BupivacainePostoperative Day Pain Medication UsePostoperative Day 103 participants
BupivacainePostoperative Day Pain Medication UsePostoperative Day 419 participants
BupivacainePostoperative Day Pain Medication UsePostoperative Day 83 participants
BupivacainePostoperative Day Pain Medication UsePostoperative Day 612 participants
BupivacainePostoperative Day Pain Medication UsePostoperative Day 92 participants
BupivacainePostoperative Day Pain Medication UsePostoperative Day 152 participants
BupivacainePostoperative Day Pain Medication UsePostoperative Day 243 participants
SalinePostoperative Day Pain Medication UsePostoperative Day 613 participants
SalinePostoperative Day Pain Medication UsePostoperative Day 515 participants
SalinePostoperative Day Pain Medication UsePostoperative Day 96 participants
SalinePostoperative Day Pain Medication UsePostoperative Day 333 participants
SalinePostoperative Day Pain Medication UsePostoperative Day 711 participants
SalinePostoperative Day Pain Medication UsePostoperative Day 426 participants
SalinePostoperative Day Pain Medication UsePostoperative Day 239 participants
SalinePostoperative Day Pain Medication UsePostoperative Day 152 participants
SalinePostoperative Day Pain Medication UsePostoperative Day 810 participants
SalinePostoperative Day Pain Medication UsePostoperative Day 107 participants
Saline GroupPostoperative Day Pain Medication UsePostoperative Day 224 participants
Saline GroupPostoperative Day Pain Medication UsePostoperative Day 615 participants
Saline GroupPostoperative Day Pain Medication UsePostoperative Day 716 participants
Saline GroupPostoperative Day Pain Medication UsePostoperative Day 812 participants
Saline GroupPostoperative Day Pain Medication UsePostoperative Day 99 participants
Saline GroupPostoperative Day Pain Medication UsePostoperative Day 117 participants
Saline GroupPostoperative Day Pain Medication UsePostoperative Day 329 participants
Saline GroupPostoperative Day Pain Medication UsePostoperative Day 428 participants
Saline GroupPostoperative Day Pain Medication UsePostoperative Day 519 participants
Saline GroupPostoperative Day Pain Medication UsePostoperative Day 109 participants
Saline Discharged ParticipantsPostoperative Day Pain Medication UsePostoperative Day 218 participants
Saline Discharged ParticipantsPostoperative Day Pain Medication UsePostoperative Day 110 participants
Saline Discharged ParticipantsPostoperative Day Pain Medication UsePostoperative Day 1010 participants
Saline Discharged ParticipantsPostoperative Day Pain Medication UsePostoperative Day 528 participants
Saline Discharged ParticipantsPostoperative Day Pain Medication UsePostoperative Day 812 participants
Saline Discharged ParticipantsPostoperative Day Pain Medication UsePostoperative Day 911 participants
Saline Discharged ParticipantsPostoperative Day Pain Medication UsePostoperative Day 716 participants
Saline Discharged ParticipantsPostoperative Day Pain Medication UsePostoperative Day 322 participants
Saline Discharged ParticipantsPostoperative Day Pain Medication UsePostoperative Day 624 participants
Saline Discharged ParticipantsPostoperative Day Pain Medication UsePostoperative Day 426 participants
Secondary

Postoperative Pain Score

Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff.

Time frame: 1and 2 hour postoperatively

Population: This doesn't include hospitalization for reasons other than pain management.

ArmMeasureGroupValue (MEAN)Dispersion
BupivacainePostoperative Pain Score1 hour postoperative4.7 units on a scaleStandard Deviation 2.9
BupivacainePostoperative Pain Score2 hours postoperative4.3 units on a scaleStandard Deviation 2.5
SalinePostoperative Pain Score2 hours postoperative2.7 units on a scaleStandard Deviation 1.8
SalinePostoperative Pain Score1 hour postoperative3.9 units on a scaleStandard Deviation 2.2
Saline GroupPostoperative Pain Score1 hour postoperative5.1 units on a scaleStandard Deviation 2
Saline GroupPostoperative Pain Score2 hours postoperative4.5 units on a scaleStandard Deviation 2.4
Saline Discharged ParticipantsPostoperative Pain Score1 hour postoperative4.5 units on a scaleStandard Deviation 2.4
Saline Discharged ParticipantsPostoperative Pain Score2 hours postoperative3.8 units on a scaleStandard Deviation 2.3
Secondary

Postoperative Pain Score

Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects self-reported their pain level.

Time frame: 1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative

Population: Only those subjects with pain analyzed

ArmMeasureGroupValue (MEAN)Dispersion
BupivacainePostoperative Pain Score2 hours postoperative3.37 units on a scaleStandard Deviation 2.19
BupivacainePostoperative Pain ScoreDay 1 postoperative3.80 units on a scaleStandard Deviation 2.53
BupivacainePostoperative Pain Score4 hours postoperative3.83 units on a scaleStandard Deviation 2.57
BupivacainePostoperative Pain ScoreDay 2 postoperative3.16 units on a scaleStandard Deviation 2.34
BupivacainePostoperative Pain Score1 hour postoperative4.30 units on a scaleStandard Deviation 2.55
SalinePostoperative Pain ScoreDay 2 postoperative3.37 units on a scaleStandard Deviation 2.39
SalinePostoperative Pain Score1 hour postoperative4.69 units on a scaleStandard Deviation 2.29
SalinePostoperative Pain Score2 hours postoperative4.01 units on a scaleStandard Deviation 2.32
SalinePostoperative Pain Score4 hours postoperative4.35 units on a scaleStandard Deviation 2.43
SalinePostoperative Pain ScoreDay 1 postoperative4.35 units on a scaleStandard Deviation 2.14

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026