Assessing Maternal Post-partum Pain With Suppositories

Pain Clinical Trial

— CRAMPS  

Official title:

CRAMPS Trial: Controlled Randomized Trial Assessing Maternal Post-partum Pain With Suppositories

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271855
• Other study ID #: 201720
• Status: Completed
• Phase: Phase 4
• First received: January 5, 2011
• Last updated: February 5, 2018
• Start date: July 22, 2009
• Est. completion date: September 29, 2011

Study information

• Verified date: February 2018
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial will evaluate whether the routine use of belladonna/opium (B&O) suppositories improve patients' self-reported pain control in the first 24-hours after delivery.

Description:

Childbirth is commonly regarded as one of life's most painful experiences and, like childbirth, the postpartum period can also be painful for women. Pain in the immediate postpartum period may significantly affect a woman's overall delivery experience. Pain control is especially important in this period, as women are bonding with their infant and trying to initiate breastfeeding, which may be adversely affected by poor pain management.

Postpartum pain may come from multiple sources. Women experience uterine cramping as a result of uterine involution. Depending on delivery type, women may also have incision pain following cesarean section or perineal pain resulting from episiotomy, perineal tears, or generalized genital trauma during delivery. Perineal pain is common, present in 75% of patients with intact perineum and up to 95-97% with perineal lacerations or episiotomies during the first day after delivery. Commonly employed methods of controlling postpartum pain include opioid analgesics, non-steroidal anti-inflammatories, acetaminophen, and topical analgesics. Pain medication is generally administered via oral or intravenous route. Several studies have investigated suppositories as an alternative method of improving pain following delivery. A double-blinded randomized controlled trial by Wilasrusmee et al (2008) showed naproxen suppositories to be effective for reducing perineal pain after vaginal delivery. Another study showed prophylactic rectal diclofenac to provide effective analgesia after perineal repair, maintained into second and third day postpartum, and a Cochrane Review showed NSAID suppositories to be associated with less pain 24 hours after birth.

Rectal analgesia provides a means of improving pain control through local effects on the perineum and uterus while possibly decreasing systemic absorption, which may in turn decrease systemic side effects and transmission to the newborn infant through breast milk. B&O suppositories contain two medications that could potentially decrease postpartum pain. Morphine, the principle agent in opium, binds opioid receptors and blocks ascending pain pathways. Atropine, a major active component of belladonna, blocks acetylcholine receptors, leading to smooth muscle relaxation. This quality may significantly improve pain from uterine contractions during the postpartum period. The primary aim of our study is to investigate whether belladonna and opium suppositories decrease patient-reported pain in the immediate postpartum period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 29, 2011
• Est. primary completion date: September 29, 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Anticipated Vaginal or Cesarean delivery at Gottlieb Medical Center or Loyola University Medical Center

• > 34 weeks gestation at time of delivery

• > 18 years old

• No known allergy to belladonna, opium, or vegetable oil suppositories

• Able to consent and complete study documents

Exclusion Criteria:

• Chronic pain condition or on narcotic medication prior to admission

• Contraindications to B&O suppositories, including patients with glaucoma, severe hepatic, or renal disease; bronchial asthma; narcotic idiosyncrasies; respiratory depression; convulsive disorders; acute alcoholism; delirium tremens; history of hypersensitivity to any component of product.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Belladonna and opioid suppository
Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
• Glycerin Suppository
A vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.

Locations

Country	Name	City	State
United States	Loyola Univeristy Medical Center	Maywood	Illinois
United States	Gottlieb Memorial Hospital	Melrose Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. — View Citation

DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg. 1998 Jan;86(1):102-6. — View Citation

Gallagher EJ, Bijur PE, Latimer C, Silver W. Reliability and validity of a visual analog scale for acute abdominal pain in the ED. Am J Emerg Med. 2002 Jul;20(4):287-90. — View Citation

Hedayati H, Parsons J, Crowther CA. Rectal analgesia for pain from perineal trauma following childbirth. Cochrane Database Syst Rev. 2003;(3):CD003931. Review. — View Citation

Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. — View Citation

Searles JA, Pring DW. Effective analgesia following perineal injury during childbirth: a placebo controlled trial of prophylactic rectal diclofenac. Br J Obstet Gynaecol. 1998 Jun;105(6):627-31. — View Citation

Wilasrusmee S, Chittachareon A, Jirasiritum S, Srisangchai P. Naproxen suppository for perineal pain after vaginal delivery. Int J Gynaecol Obstet. 2008 Jul;102(1):19-22. doi: 10.1016/j.ijgo.2008.01.015. Epub 2008 Mar 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Level Twenty Four Hours After Delivery	The primary outcome is pain measured at 24-hours after delivery. Patients will be asked to report a Visual Analog Scale (VAS) pain score at 24-hours after delivery. This scale ranges from 0 to 10 (0=no pain and 10=worst pain).	Twenty-four hours
Secondary	Number of Patients Taking Additional Pain Medications	Twenty-four hours after delivery, the number of participants taking additional pain medications will be recorded.	Twenty-four hours
Secondary	Patient Satisfaction	Patients' satisfaction with their pain control is recorded at the time of discharge using a five point scale ranging from 1 (Not Satisfied) to 3 (Okay) to 5 (Very Satisfied).	Discharge